Laboratoires Genevirer Menotrophin LG IU 1.8.2

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Laboratoires Genevirer Menotrophin LG IU 1.8.2"

Transcription

1 Menotrophin LG IU.8.2 VI.2 VI.2. Elements for a Public Summary Overview of disease epidemiology Infertility is when a woman cannot get pregnant (conceive) despite having regular unprotected sexual intercourse. Infertility is diagnosed when a couple have being unable to conceive after trying for at least 2 years. There are many possible causes of infertility and fertility problems can affect both men and women. Infertility becomes more common with increasing age. Problems with ovulation (the monthly release of an egg) are one of the leading causes of infertility accounting for about in 4 cases of female infertility. One of the most common ovulation disorders to cause infertility is polycystic ovary syndrome (PCOS). PCOS is a condition which makes it more difficult for an egg to be released and accounts for about 73% of infertility cases due to ovulation disorders. Although infertility is not a life-threatening condition, being unable to have a child can cause depression and anxiety for those couples that are affected. VI.2.2 Summary of treatment benefits Fertility treatments are medical techniques which help women to have children. There are three main types of fertility treatments: Medical treatment to restore fertility: this generally involves the use of drugs, such as clomiphene or gonadotrophins, to encourage ovulation. Controlled ovarian hyperstimulation (COH) is a type of medical treatment during which drugs are used to produce multiple ovarian follicles (each follicle is a fluid-filled sac that contains an egg) in one treatment cycle to improve pregnancy rates. COH can be used during assisted conception, described below. Assisted conception: this is also known as assisted reproduction technology (ART) and includes in vitro fertilisation (IVF). This technique involves removing eggs from a woman s body, mixing them with sperm to produce embryos, and then placing these back in the woman s body. This helps conception without the need for vaginal intercourse. Surgical treatments: these can be used to restore fertility. The choice of treatment used depends on the type of infertility that has been diagnosed. In the UK, about in 7 couples seek medical advice for infertility. Across Europe, the availability of different fertility treatments varies. In particular, different countries have adopted different legal approaches with respect to assisted conception. However, Europe leads the world (excluding Asia) for ART treatment, starting approximately 7% of all reported ART cycles. The impact of successful infertility treatment cannot be underestimated For the purposes of this Summary, we will discuss the first two treatments.

2 Menotrophin LG IU.8.2 For women who are infertile due to ovulation disorders, clomiphene citrate or metformin or a combination of the two medicines are then recommended as the first treatment option toencourage ovulation. Clomiphene citrate may not work in some women and for these patients, another treatment option is to combine clomiphene citrate with metformin, if that is hasn t been already tried, or to have gonadotrophin therapy. Gonadotrophins are hormones which are naturally found in the human body. A type of gonadotrophin that is commonly used for the treatment of infertility is human menopausal gonadotrophin (HMG) which contains three hormones: follicle-stimulating hormone (FSH), luteinising hormone (LH) and human chorionic gonadotrophin (hcg). These hormones stimulate the ovaries to produce follicles which each contain an egg (oocyte). HMG products are well known and have been used as infertility treatment for over 40 years. HMG products are also one of the standard treatments offered to couples as a first option for ensuring controlled ovarian hyperstimulation (COH) when they are undergoing ART such as IVF. Menotrophin LG IU is a new HMG drug which can be used to treat infertility in women with ovulation disorders and for women who are undergoing ART. Main studies: Two clinical studies have been performed to see how effective Menotrophin LG IU is when it is given to women undergoing COH in ART. In both studies, Menotrophin LG IU was compared with another HMG product called Menopur. Menopur is very similar to Menotrophin LG IU. Both medicines were injected under the skin of each patient; this is known as a subcutaneous injection. A total of 427 female patients took part in these studies. Supporting study: In addition, a supporting clinical study was performed with Merional another HMG product which is very similar to Menotrophin LG IU when it is injected either into the muscle or under the skin (sub-cutaneous injection) of women undergoing COH in ART. A total of 68 female patients involved in this study. In the main studies, no detectable differences were seen between Menotrophin LG IU and Menopur. Both treatments produced a similar number of eggs (oocytes) and showed a safe and adequate response. In the supporting study, no detectable differences were seen between the different injection techniques of subcutaneous and intramuscular. No post-authorisation data are available for Menotrophin LG IU at present because it has not been available on the market for very long. However, other similar HMG products, such as Merional and Menopur, have been successfully used for over 40 years for the treatment of infertility in women so no problems are anticipated for Menotrophin LG IU. VI.2.3 Unknowns relating to treatment benefits In the studies all patients were female, white Caucasians aged between 2 and 40. There is no evidence to suggest that results would be any different in non-white patients and this age range is considered to be representative of the women most likely to undergo fertility treatment. The biggest difference in older patients would be the greater likelihood of treatment failure and any safety EMA/78034/202 2

3 Menotrophin LG IU.8.2 concerns would be the same as those experienced by the age group of patients who took part in the clinical trials. The women who took part in these studies had a body mass index of between 8 to 30 kgm 2. Women who are under or overweight may have more difficulty in becoming pregnant. Indeed, guidelines in the UK, issued by the National Institute of Health and Clinical Excellence (NICE) recommend that women should be informed that the ideal BMI is in the range 9-30 kg/m 2 before they start fertility treatment. Although all women undergoing fertility treatment are at potential risk, women with PCOS are at higher risk of experiencing ovarian hyperstimulation syndrome (OHSS). OHSS is a well-known side effect of fertility treatment which causes the ovaries to swell up and produce too many follicles. Women with PCOS did not take part in the clinical studies. However, usage of HMG products that are very similar to Menotrophin LG has shown the safety and effectiveness of these medicines. Furthermore, only licensed clinics or recognised fertility experts are allowed to prescribe these fertility drugs and patients are closely monitored for OHSS. It is standard practice for these clinics carrying out such treatments to have acceptable processes in place to manage OHSS. EMA/78034/202 3

4 Menotrophin LG IU.8.2 VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Swollen ovaries and over production of follicles (ovarian hyperstimulation syndrome) Having more than one baby (e.g. twins) in a single pregnancy (multiple pregnancy) Skin reactions at the place where the injection is given using a needle (Injection site reactions) OHSS is a well-known side effect of fertility treatment. The occurrence of OHSS is higher in young women, women with PCOS and in treatment cycles during which conception occurs. In the UK, most cases of OHSS are mild to moderate in severity and affect up to in 20 (5%) of all patients undergoing IVF treatment. More severe cases of OHSS are less common (up to in 00 (0.5- %) of all IVF cycles) and require hospitalisation to be treated. Severe OHSS normally responds to treatment. Very rarely, OHSS is life-threatening. After infertility treatment, multiple pregnancies, especially twins, are relatively common. It is the single greatest health risk associated with fertility treatment. In patients undergoing ART, the risk of multiple pregnancy is related to how many embryos are placed inside the woman s body, the quality of these embryos and the patient s age. Legally, doctors are not allowed to transfer more than two embryos if a woman is under the age of 40 and no more than three for women who are aged 40. Women over 40 are at much lower risk of multiple pregnancy and its complications. A reaction to a needle injection is a known but usually non-serious and mild side effect. The side effects may include one or more of itching, rash, pain and redness where the needle was injected into the skin. Only licensed clinics or recognised fertility experts are able to prescribe fertility drugs. Patients are closely monitored for OHSS during fertility treatment. It is standard practice for all clinics carrying out fertility treatment to have acceptable processes in place to manage OHSS. Only licensed clinics or recognised fertility experts are able to prescribe fertility drugs and patients are closely monitored for this known and expected side effect during treatment. For some patients it may not be enough to just inform them about the chance of twin or multiple pregnancy. For these patients, their doctor will provide additional information about the increased risk of serious complications, like birth defects such as cerebral palsy. If patients require more than one injection, their doctor will advise them to inject into different places around the body or a smaller needle can be used. As this is a known side effect of needle injections, the patients will be monitored. EMA/78034/202 4

5 Menotrophin LG IU.8.2 Important potential risks Risk False pregnancy when the egg implants itself outside the womb (ectopic pregnancy) Loss of pregnancy; abortion or miscarriage (pregnancy wastage) What is known (Including reason why it is considered a potential risk) The number of ectopic pregnancies seen after IVF treatment varies between 2-% of all pregnancies. This is higher than the number reported after natural conception (%). It is unclear why infertile patients have a higher risk of experiencing an ectopic pregnancy. The incidence of pregnancy wastage by miscarriage or abortion is higher in patients undergoing fertility treatment than those who aren t. Most early pregnancy losses are due to genetic problems in the developing embryo at about 6-8 weeks. Because women who are having fertility treatment know the correct date of the pregnancy test, they will be able to recognise the very early signs of miscarriage more quickly than women who have no fertility problems. A complete abortion is unlikely to cause a life-threatening risk unless a significant amount of blood is lost or infection occurs. Illness may be increased if anaemia or infection develops. Incomplete abortions happen when pregnancy tissue is left in the womb. These are a cause for concern particularly when significant bleeding or infection occurs. If pregnancy tissue is left in the womb, patients may experience symptoms of increased bleeding, increased cramping, and/or infection. Cancer of the reproductive organs (reproductive system neoplasms) Birth defects (congenital malformations) Blood clots (thromboembolic events {TEE}) The seriousness of the condition depends on the type of cancer diagnosed. It should be noted that no link has been confirmed between fertility treatment and cancer. The number of cases of birth defects after ART may be slightly higher than after a natural pregnancy. However, the occurrence of birth defects after fertility treatment still remains rare. In addition, there is no conclusive evidence to link fertility treatment with any specific birth defect. These may affect the arteries or veins. In the veins this may lead to a painful swelling of the legs (deep vein thrombosis) and very occasionally life threatening or fatal clots in the lungs. Clots in the arteries may lead to a heart attack or stroke particularly in patients who already have problems with their arteries. Clots are rare but are a serious complication that can occur during fertility treatment. They are usually associated with OHSS. Other possible causes may be a personal or family history of clots, severe obesity (BMI >30 kg/m 2 ) or your blood has a higher tendency to clot. It should be noted that pregnancy, even without fertility treatment, also carries an increased risk of blood clots developing. Important missing information Not Applicable. EMA/78034/202 5

6 Menotrophin LG IU.8.2 VI.2.5 Summary of additional risk minimisation measures by safety concern All medicines have a Summary of Product Characteristics (SmPC) which provides physicians, pharmacists and other health care professionals with details of how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PIL). The measures in these documents are known as routine risk minimisation measures. This medicine has no additional risk minimisation measures. VI.2.6 Planned post authorisation development plan Not applicable. Studies which are a condition of the marketing authorisation Not applicable. VI.2.7 Summary of changes to the Risk Management Plan over time Not applicable. EMA/78034/202 6

POLYCYSTIC OVARY SYNDROME

POLYCYSTIC OVARY SYNDROME POLYCYSTIC OVARY SYNDROME Information Leaflet Your Health. Our Priority. Page 2 of 6 What is polycystic ovary syndrome? (PCOS) Polycystic ovary syndrome (PCOS) is the most common hormonal disorder in women

More information

Polycystic Ovarian Syndrome

Polycystic Ovarian Syndrome Polycystic Ovarian Syndrome What is Polycystic Ovarian Syndrome? Polycystic ovary syndrome (or PCOS) is a common condition affecting 3 to 5% of women of reproductive age. It is linked with hormonal imbalances,

More information

Clinical Policy Committee

Clinical Policy Committee Northern, Eastern and Western Devon Clinical Commissioning Group South Devon and Torbay Clinical Commissioning Group Clinical Policy Committee Commissioning policy: Assisted Conception Fertility assessment

More information

FERTILITY AND AGE. Introduction. Fertility in the later 30's and 40's. Am I fertile?

FERTILITY AND AGE. Introduction. Fertility in the later 30's and 40's. Am I fertile? FERTILITY AND AGE Introduction Delaying pregnancy is a common choice for women in today's society. The number of women in their late 30s and 40s attempting pregnancy and having babies has increased in

More information

Pre-implantation Genetic Diagnosis (PGD)

Pre-implantation Genetic Diagnosis (PGD) Saint Mary s Hospital Department of Genetic Medicine Saint Mary s Hospital Pre-implantation Genetic Diagnosis (PGD) Information For Patients What is PGD? Pre-implantation genetic diagnosis (PGD) is a specialised

More information

The relevant NICE Clinical Guidance 156, Fertility can be accessed here: http://www.nice.org.uk/guidance/cg156

The relevant NICE Clinical Guidance 156, Fertility can be accessed here: http://www.nice.org.uk/guidance/cg156 City and Hackney CCG Fertility policy Approved January 2015 Introduction City and Hackney CCG is responsible for commissioning a range of health services including hospital, mental health and community

More information

Tower Hamlets CCG Fertility policy

Tower Hamlets CCG Fertility policy Tower Hamlets CCG Fertility policy Approved December 2014 Introduction Tower Hamlets CCG is responsible for commissioning a range of health services including hospital, mental health and community services

More information

Fertility care for women diagnosed with cancer

Fertility care for women diagnosed with cancer Saint Mary s Hospital Department of Reproductive Medicine Fertility care for women diagnosed with cancer Information For Patients INF/DRM/NUR/16 V1/01/11/2013 1 2 Contents Page Overview 4 Our Service 4

More information

Risk Management Plan

Risk Management Plan Risk Management Plan Active substance: Drospirenone/ethinylestradiol Version number: 4.0 VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Oral contraception Effective control

More information

In Vitro Fertilization

In Vitro Fertilization Patient Education In Vitro Fertilization What to expect This handout describes how to prepare for and what to expect when you have in vitro fertilization. It provides written information about this process,

More information

How do fertility drugs work?

How do fertility drugs work? How do fertility drugs work? Under normal circumstances, ovulation occurs once a month when a ripened egg which is ready to be fertilised is released from the ovaries. For couples who are trying to conceive,

More information

Fertility Facts and Figures 2008

Fertility Facts and Figures 2008 Fertility Facts and Figures 2008 Contents About these statistics... 2 Accessing our data... 2 The scale of fertility problems... 3 Treatment abroad... 3 Contacts regarding this publication... 3 Latest

More information

Risks and complications of assisted conception

Risks and complications of assisted conception Risks and complications of assisted conception August 005 Richard Kennedy British Fertility Society Factsheet www.fertility.org.uk No medical treatment is entirely free from risk and infertility treatment

More information

it right? activity (page 4) to highlight ethical issues associated with IVF

it right? activity (page 4) to highlight ethical issues associated with IVF IN VITRO FERTILIZATION I V F In some cases, a sperm is directly injected into an egg IVF: THE MEETING OF SPERM AND EGG IN GLASS Louise Brown, the first test tube baby was born in 1978. Since then, there

More information

Clinical Reference Group Quality & Safety Committee Governing Body. Policy Screened

Clinical Reference Group Quality & Safety Committee Governing Body. Policy Screened Fertility Policy 1 SUMMARY This policy is intended to support individuals and couples who want to become parents but who have a possible pathological problem (physical or psychological) leading to them

More information

CONSENT TO PARTICIPATE IN THE IN VITRO FERTILIZATION-EMBRYO TRANSFER PROGRAM

CONSENT TO PARTICIPATE IN THE IN VITRO FERTILIZATION-EMBRYO TRANSFER PROGRAM CONSENT TO PARTICIPATE IN THE IN VITRO FERTILIZATION-EMBRYO TRANSFER PROGRAM I, after consultation with my physician, request to participate in the In Vitro Fertilization (IVF)-Embryo Transfer (ET) procedures

More information

Getting Pregnant: The Natural Approach Revealing the Secrets to Increase Your Fertility

Getting Pregnant: The Natural Approach Revealing the Secrets to Increase Your Fertility Getting Pregnant: The Natural Approach Revealing the Secrets to Increase Your Fertility Page 1 Contents Introduction 3 Part I Understanding Fertility and Infertility Chapter 1: What is Fertility? 4 - Signs

More information

Information for you Treatment of venous thrombosis in pregnancy and after birth. What are the symptoms of a DVT during pregnancy?

Information for you Treatment of venous thrombosis in pregnancy and after birth. What are the symptoms of a DVT during pregnancy? Information for you Treatment of venous thrombosis in pregnancy and after birth Published in September 2011 What is venous thrombosis? Thrombosis is a blood clot in a blood vessel (a vein or an artery).

More information

Polycystic ovary syndrome: what it means for your long-term health

Polycystic ovary syndrome: what it means for your long-term health Polycystic ovary syndrome: what it means for your long-term health Information for you Published in February 2005, minor amendments in June 2005 Revised 2009 What is polycystic ovary syndrome? Polycystic

More information

Artificial insemination with donor sperm

Artificial insemination with donor sperm Artificial insemination with donor sperm Ref. 123 / 2009 Reproductive Medicine Unit Servicio de Medicina de la Reproducción Gran Vía Carlos III 71-75 08028 Barcelona Tel. (+34) 93 227 47 00 Fax. (+34)

More information

Final Version Two (Sept 2014) Eastern Cheshire Clinical Commissioning Group NHS Funded Treatment for Subfertility Policy

Final Version Two (Sept 2014) Eastern Cheshire Clinical Commissioning Group NHS Funded Treatment for Subfertility Policy Final Version Two (Sept 2014) Eastern Cheshire Clinical Commissioning Group NHS Funded Treatment for Subfertility Policy NHS FUNDED TREATMENT FOR SUBFERTILITY ELIGIBILITY CRITERIA Table of Contents 1.

More information

, hereby agree to a form of treatment known

, hereby agree to a form of treatment known Patient Consent for Therapy Human In Vitro Fertilization and Embryo Transfer This is to certify that I, as In Vitro Fertilization and Embryo Transfer., hereby agree to a form of treatment known I have

More information

WOMENCARE A Healthy Woman is a Powerful Woman (407) 898-1500. Birth Control Pills

WOMENCARE A Healthy Woman is a Powerful Woman (407) 898-1500. Birth Control Pills Birth Control Pills WOMENCARE A Healthy Woman is a Powerful Woman (407) 898-1500 Birth control pills (also called oral contraceptives or "the pill") are used by millions of women in the United States to

More information

ELEMENTS FOR A PUBLIC SUMMARY. Overview of disease epidemiology. Summary of treatment benefits

ELEMENTS FOR A PUBLIC SUMMARY. Overview of disease epidemiology. Summary of treatment benefits VI: 2 ELEMENTS FOR A PUBLIC SUMMARY Bicalutamide (CASODEX 1 ) is a hormonal therapy anticancer agent, used for the treatment of prostate cancer. Hormones are chemical messengers that help to control the

More information

Standardising Access Criteria to NHS Fertility Treatment FOR COMMISSIONERS OF FERTILITY SERVICES

Standardising Access Criteria to NHS Fertility Treatment FOR COMMISSIONERS OF FERTILITY SERVICES Standardising Access Criteria to NHS Fertility Treatment FOR COMMISSIONERS OF FERTILITY SERVICES Status of the document This document offers guidance to help PCTs move towards more equitable provision

More information

FDA-Approved Patient Labeling IMPLANON (etonogestrel implant) Subdermal Use

FDA-Approved Patient Labeling IMPLANON (etonogestrel implant) Subdermal Use FDA-Approved Patient Labeling IMPLANON (etonogestrel implant) Subdermal Use IMPLANON does not protect against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases. Read this

More information

Uterine fibroids (Leiomyoma)

Uterine fibroids (Leiomyoma) Uterine fibroids (Leiomyoma) What are uterine fibroids? Uterine fibroids are fairly common benign (not cancer) growths in the uterus. They occur in about 25 50% of all women. Many women who have fibroids

More information

implant contraceptiv contraceptive contraceptive raceptiv contraceptive implant contraceptive contraceptive ontraceptive implant ontraceptive im

implant contraceptiv contraceptive contraceptive raceptiv contraceptive implant contraceptive contraceptive ontraceptive implant ontraceptive im your guide to the contraceptive implant Helping you choose the method of contraception that is best for you contra ontraceptive im contraceptive implant mpl ceptive contraceptive contracepti ntraceptive

More information

Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Polycystic Ovary Syndrome Polycystic ovary syndrome (PCOS) is a disorder that affects as many as 5 10% of women. PCOS has three key features: 1) high levels of hormones called androgens; 2) irregular menstrual

More information

Consent for Frozen Donor Oocyte In Vitro Fertilization and Embryo Transfer (Recipient)

Consent for Frozen Donor Oocyte In Vitro Fertilization and Embryo Transfer (Recipient) Name of Patient: Name of Partner: We, the Patient and Partner (if applicable) named above, are each over the age of twenty-one (21) years. By our signatures below, I/we request and authorize the performance

More information

The cost-effectiveness of IVF in the UK: a comparison of three gonadotrophin treatments Sykes D, Out H J, Palmer S J, van Loon J

The cost-effectiveness of IVF in the UK: a comparison of three gonadotrophin treatments Sykes D, Out H J, Palmer S J, van Loon J The cost-effectiveness of IVF in the UK: a comparison of three gonadotrophin treatments Sykes D, Out H J, Palmer S J, van Loon J Record Status This is a critical abstract of an economic evaluation that

More information

Polycystic ovary syndrome (PCOS)

Polycystic ovary syndrome (PCOS) Centre for Diabetes and Endocrinology - Patient information Polycystic ovary syndrome (PCOS) Approximately 1 in 5 women have polycystic ovaries. This describes the appearance of the ovaries when they are

More information

Confirmed Deep Vein Thrombosis (DVT)

Confirmed Deep Vein Thrombosis (DVT) Confirmed Deep Vein Thrombosis (DVT) Information for patients What is deep vein thrombosis? Blood clotting provides us with essential protection against severe loss of blood from an injury to a vein or

More information

progestog progestogen stogen-only pill progestogen progestogen-only pill he progestogen-only pill progestogen-onl progestogen-o the progestogenonly

progestog progestogen stogen-only pill progestogen progestogen-only pill he progestogen-only pill progestogen-onl progestogen-o the progestogenonly your guide to the progestogenonly pill Helping you choose the method of contraception that is best for you the progestogen rogestogen-only the progestogen-only pill progestogen-only pill stogen-only progestoge

More information

FACT SHEET. The Polycystic Ovary Syndrome (PCOS) Introduction

FACT SHEET. The Polycystic Ovary Syndrome (PCOS) Introduction FACT SHEET The Polycystic Ovary Syndrome (PCOS) Introduction The polycystic ovary syndrome (PCOS) is the commonest hormonal disturbance to affect women. The main problems that women with PCOS experience

More information

Summary of the risk management plan (RMP) for Otezla (apremilast)

Summary of the risk management plan (RMP) for Otezla (apremilast) EMA/741412/2014 Summary of the risk management plan (RMP) for Otezla (apremilast) This is a summary of the risk management plan (RMP) for Otezla, which details the measures to be taken in order to ensure

More information

In Vitro Fertilization (IVF) Page 1 of 11

In Vitro Fertilization (IVF) Page 1 of 11 In Vitro Fertilization (IVF) Page 1 of 11 This document is a part of your informed consent process. Both partners should read the entire document carefully. In vitro fertilization (IVF) is a treatment

More information

Preventing Blood Clots in Adult Patients. Information For Patients

Preventing Blood Clots in Adult Patients. Information For Patients Preventing Blood Clots in Adult Patients Information For Patients 1 This leaflet will give you information on how to reduce the risk of developing blood clots during and after your stay in hospital. If

More information

Understanding Endometriosis - Information Pack

Understanding Endometriosis - Information Pack What is endometriosis? Endometriosis (pronounced en- doh mee tree oh sis) is the name given to the condition where cells like the ones in the lining of the womb (uterus) are found elsewhere in the body.

More information

Menstruation and the Menstrual Cycle

Menstruation and the Menstrual Cycle Menstruation and the Menstrual Cycle Q: What is menstruation? A: Menstruation is a woman s monthly bleeding, also called a period. When you menstruate, your body is shedding the lining of the uterus (womb).

More information

Patient Guide. Important information for patients starting therapy with LEMTRADA (alemtuzumab)

Patient Guide. Important information for patients starting therapy with LEMTRADA (alemtuzumab) Patient Guide Important information for patients starting therapy with LEMTRADA (alemtuzumab) This medicinal product is subject to additional monitoring. This will allow quick identification of new safety

More information

BUTTE COUNTY PUBLIC HEALTH DEPARTMENT POLICY & PROCEDURE

BUTTE COUNTY PUBLIC HEALTH DEPARTMENT POLICY & PROCEDURE BUTTE COUNTY PUBLIC HEALTH DEPARTMENT POLICY & PROCEDURE SUBJECT: Pregnancy Testing and Counseling Protocol P&P # APPROVED BY: EFFECTIVE DATE: Mark Lundberg MD Health Officer REVISION DATE: 2/20/2010 Phyllis

More information

Assisted Conception Policy. February 2016. Dr. Liz Saunders Cyril Haessig

Assisted Conception Policy. February 2016. Dr. Liz Saunders Cyril Haessig Assisted Conception Policy February 2016 Dr. Liz Saunders Cyril Haessig CONTENTS Executive Summary... 3 Policy outline... 5 Detailed criteria... 8-2 - ASSISTED CONCEPTION COMMISSIONING POLICY EXECUTIVE

More information

Carol Ludowese, MS, CGC Certified Genetic Counselor HDSA Center of Excellence at Hennepin County Medical Center Minneapolis, Minnesota

Carol Ludowese, MS, CGC Certified Genetic Counselor HDSA Center of Excellence at Hennepin County Medical Center Minneapolis, Minnesota Carol Ludowese, MS, CGC Certified Genetic Counselor HDSA Center of Excellence at Hennepin County Medical Center Minneapolis, Minnesota The information provided by speakers in workshops, forums, sharing/networking

More information

Summary of the risk management plan (RMP) for Xultophy (insulin degludec / liraglutide)

Summary of the risk management plan (RMP) for Xultophy (insulin degludec / liraglutide) EMA/467911/2014 Summary of the risk management plan (RMP) for Xultophy (insulin degludec / liraglutide) This is a summary of the risk management plan (RMP) for Xultophy, which details the measures to be

More information

In - Vitro Fertilization Handbook

In - Vitro Fertilization Handbook In - Vitro Fertilization Handbook William F. Ziegler, D.O. Medical Director Scott Kratka, ELD, TS Embryology Laboratory Director Lauren F. Lucas, P.A.-C, M.S. Physician Assistant Frances Cerniak, R.N.

More information

Endometriosis, Fertility and Pregnancy

Endometriosis, Fertility and Pregnancy This leaflet covers endometriosis and fertility. It provides information for women who have been diagnosed with endometriosis who would like to know if and how this can affect their fertility, and for

More information

DARTMOUTH-HITCHCOCK MEDICAL CENTER Lebanon, New Hampshire IN VITRO FERTILIZATION PROCEDURE DESCRIPTION

DARTMOUTH-HITCHCOCK MEDICAL CENTER Lebanon, New Hampshire IN VITRO FERTILIZATION PROCEDURE DESCRIPTION DARTMOUTH-HITCHCOCK MEDICAL CENTER Lebanon, New Hampshire IN VITRO FERTILIZATION PROCEDURE DESCRIPTION I. INTRODUCTION A. The Assisted Reproductive Technology (ART) Program. The ART Program is operated

More information

Lakeview Endocrinology and Diabetes Consultants. 2719 N Halsted St C-1. Chicago IL 60614 P: 773 388 5685 F: 773 388 5687. www.lakeviewendocrinolgy.

Lakeview Endocrinology and Diabetes Consultants. 2719 N Halsted St C-1. Chicago IL 60614 P: 773 388 5685 F: 773 388 5687. www.lakeviewendocrinolgy. Lakeview Endocrinology and Diabetes Consultants 2719 N Halsted St C-1 Chicago IL 60614 P: 773 388 5685 F: 773 388 5687 www.lakeviewendocrinolgy.com Patient information: Early menopause (premature ovarian

More information

Timing is everything. Ovulation Tracking. Patient Information Booklet

Timing is everything. Ovulation Tracking. Patient Information Booklet Timing is everything Ovulation Tracking Patient Information Booklet Contents Getting pregnant naturally 3 Getting pregnant the basics 3 What is ovulation? 3 Menstrual cycle 4 When does ovulation take place?

More information

Informed Consent Packet - In Vitro Fertilization (IVF)

Informed Consent Packet - In Vitro Fertilization (IVF) Center for Reproductive Medicine (CRM) Informed Consent Packet - In Vitro Fertilization (IVF) This packet contains the required IVF treatment consent documents. Please read, consider and, if you agree,

More information

IN VITRO FERTILISATION IVF and ICSI

IN VITRO FERTILISATION IVF and ICSI IN VITRO FERTILISATION IVF and ICSI Page 1 of 7 WHAT ARE IVF and ICSI? IVF is short for in vitro fertilisation which means fertilisation outside the body. It usually involves stimulation of the ovaries

More information

Assisted Reproductive Technologies at IGO

Assisted Reproductive Technologies at IGO 9339 Genesee Avenue, Suite 220 San Diego, CA 92121 858 455 7520 Assisted Reproductive Technologies at IGO Although IGO no longer operates an IVF laboratory or program as such, we work closely with area

More information

Age and Fertility. A Guide for Patients PATIENT INFORMATION SERIES

Age and Fertility. A Guide for Patients PATIENT INFORMATION SERIES Age and Fertility A Guide for Patients PATIENT INFORMATION SERIES Published by the American Society for Reproductive Medicine under the direction of the Patient Education Committee and the Publications

More information

Causes for unintentional childlessness

Causes for unintentional childlessness Causes for unintentional childlessness We can define fertility as the inability to become pregnant after one year of regular sexual intercourse. The causes of infertility are evenly distributed among men

More information

Reproductive Technology. Chapter 21

Reproductive Technology. Chapter 21 Reproductive Technology Chapter 21 Assisted Reproduction When a couple is sub-fertile or infertile they may need Assisted Reproduction to become pregnant: Replace source of gametes Sperm, oocyte or zygote

More information

KUTTEH KE FERTILITY ASSOCIATES OF MEMPHIS, PLLC AND MEMPHIS FERTILITY LABORATORY, INC.

KUTTEH KE FERTILITY ASSOCIATES OF MEMPHIS, PLLC AND MEMPHIS FERTILITY LABORATORY, INC. 1 of 6 KUTTEH KE FERTILITY ASSOCIATES OF MEMPHIS, PLLC 80 Humphreys Center, Suite 307 Memphis, Tennessee 38120-2363 (901) 747-2229 AND MEMPHIS FERTILITY LABORATORY, INC. IN VITRO FERTILIZATION/EMBRYO TRANSFER

More information

The Menstrual Cycle, Hormones and Fertility Treatment

The Menstrual Cycle, Hormones and Fertility Treatment The Menstrual Cycle, Hormones and Fertility Treatment How many of us understand how our monthly cycle works? Every 28 days (or thereabouts), between the ages of around 13 and 51, a woman will release a

More information

Consent for In Vitro Fertilization

Consent for In Vitro Fertilization Consent for In Vitro Fertilization Print Patient s Name Print Partner s Name We (I), the undersigned, request, authorize and consent to the procedure of In Vitro Fertilization (IVF) and Embryo Transfer

More information

HEALTH UPDATE. Polycystic Ovary Syndrome (PCOS)

HEALTH UPDATE. Polycystic Ovary Syndrome (PCOS) HEALTH UPDATE PO Box 800760 Charlottesville, VA 22908 Gynecology: (434) 924-2773 Polycystic Ovary Syndrome (PCOS) What is it? An endocrine (hormonal) disorder. Because there is such variability in how

More information

Polycystic Ovarian Syndrome (PCOS)

Polycystic Ovarian Syndrome (PCOS) UW MEDICINE PATIENT EDUCATION Polycystic Ovarian Syndrome (PCOS) Signs, symptoms, and treatments What is PCOS? Polycystic ovarian syndrome (PCOS) is a disorder that affects up to 1 in 10 women of reproductive

More information

טופס הסכמה לטיפולי הפרייה חוץ גופית

טופס הסכמה לטיפולי הפרייה חוץ גופית טופס הסכמה לטיפולי הפרייה חוץ גופית CONSENT FORM: IN-VITRO FERTILIZATION (IVF) 1. General In-vitro fertilization is performed in cases of impaired fertility, which may be caused by the following: Obstruction

More information

Fertility-related choices. A decision aid for younger women with early breast cancer

Fertility-related choices. A decision aid for younger women with early breast cancer Fertility-related choices A decision aid for younger women with early breast cancer Fertility-related choices Section 1 About this booklet 1 Overview 3 Summary of fertility options 4 Section 2 Some background

More information

What Does Pregnancy Have to Do With Blood Clots in a Woman s Legs?

What Does Pregnancy Have to Do With Blood Clots in a Woman s Legs? Patient s Guide to Prevention of Blood Clots During Pregnancy: Use of Blood-Thinning A Patient s Guide to Prevention of Blood Clots During Pregnancy: Use of Blood-Thinning Drugs to Prevent Abnormal Blood

More information

THE CENTER FOR ADVANCED REPRODUCTIVE SERVICES (CARS) (The Center) CONSENT FOR IN VITRO FERTILIZATION AND EMBRYO TRANSFER

THE CENTER FOR ADVANCED REPRODUCTIVE SERVICES (CARS) (The Center) CONSENT FOR IN VITRO FERTILIZATION AND EMBRYO TRANSFER THE CENTER FOR ADVANCED REPRODUCTIVE SERVICES (CARS) (The Center) CONSENT FOR IN VITRO FERTILIZATION AND EMBRYO TRANSFER Partner #1 Last Name (Surname): Partner #1 First Name: Partner #1 Last 5 Digits

More information

REPRODUCTIVE MEDICINE AND INFERTILITY ASSOCIATES Woodbury Medical Arts Building 2101 Woodwinds Drive Woodbury, MN 55125 (651) 222-6050

REPRODUCTIVE MEDICINE AND INFERTILITY ASSOCIATES Woodbury Medical Arts Building 2101 Woodwinds Drive Woodbury, MN 55125 (651) 222-6050 REPRODUCTIVE MEDICINE AND INFERTILITY ASSOCIATES Woodbury Medical Arts Building 2101 Woodwinds Drive Woodbury, MN 55125 (651) 222-6050 RECIPIENT COUPLE INFORMED CONSENT AND AUTHORIZATION FOR IN VITRO FERTILIZATION

More information

SO, WHAT IS A POOR RESPONDER?

SO, WHAT IS A POOR RESPONDER? SO, WHAT IS A POOR RESPONDER? We now understand why ovarian reserve is important and how we assess it, but how is poor response defined? Unfortunately, there is no universally accepted definition for the

More information

Acute pelvic inflammatory disease: tests and treatment

Acute pelvic inflammatory disease: tests and treatment Acute pelvic inflammatory disease: tests and treatment Information for you Information for you Published August 2010 Published in August 2010 (next review date: 2014) Acute What is pelvic inflammatory

More information

Female Reproductive System. Unit 8 Lesson 2 Continued

Female Reproductive System. Unit 8 Lesson 2 Continued Female Reproductive System Unit 8 Lesson 2 Continued Female Reproductive System Female Reproductive System Female produce ovum or egg cells. The egg (ovum) cell is the female sex cell. Female Reproductive

More information

Egg Donation Process, Risks, Consent and Agreement

Egg Donation Process, Risks, Consent and Agreement THE CENTER FOR HUMAN REPRODUCTION (CHR) 21 East 69 th Street, New York, NY 10021 T: 212-994-4400; F: 212-994-4499 Egg Donation Process, Risks, Consent and Agreement Updated on: 10/8/2014 Date: Egg Donor

More information

Patient Information Leaflet: Part 1 select-d

Patient Information Leaflet: Part 1 select-d Patient Information Leaflet: Part 1 select-d Anticoagulation Therapy in SELECTeD Cancer Patients at Risk of Recurrence of Venous Thromboembolism Introduction This

More information

abortion your questions answered

abortion your questions answered abortion your questions answered About Marie Stopes International Marie Stopes International is a specialist reproductive healthcare organisation and a registered charity working in both the UK and overseas.

More information

Preimplantation Genetic Diagnosis. Evaluation for single gene disorders

Preimplantation Genetic Diagnosis. Evaluation for single gene disorders Preimplantation Genetic Diagnosis Evaluation for single gene disorders What is Preimplantation Genetic Diagnosis? Preimplantation genetic diagnosis or PGD is a technology that allows genetic testing of

More information

Commissioning Policy for In Vitro Fertilisation (IVF)/ Intracytoplasmic Sperm Injection (ICSI) within tertiary Infertility Services.

Commissioning Policy for In Vitro Fertilisation (IVF)/ Intracytoplasmic Sperm Injection (ICSI) within tertiary Infertility Services. East Midlands CCGs Commissioning Policy for In Vitro Fertilisation (IVF)/ Intracytoplasmic Sperm Injection (ICSI) within tertiary Infertility Services April 2014 CONTENTS Page 1. INTRODUCTION 3 2. GENERAL

More information

MODEL FORM. [Program s SART Name and Number] INFORMED CONSENT FOR EGG DONORS

MODEL FORM. [Program s SART Name and Number] INFORMED CONSENT FOR EGG DONORS MODEL FORM [Program s SART Name and Number] INFORMED CONSENT FOR EGG DONORS You are agreeing to undergo a cycle of egg donation at [program s SART name]. Do not sign this document if you have not received

More information

Summary of the risk management plan (RMP) for Ionsys (fentanyl)

Summary of the risk management plan (RMP) for Ionsys (fentanyl) EMA/764409/2015 Summary of the risk management plan (RMP) for Ionsys (fentanyl) This is a summary of the risk management plan (RMP) for Ionsys, which details the measures to be taken in order to ensure

More information

Our laboratory guide for you and your embryos

Our laboratory guide for you and your embryos Lab guide Our laboratory guide for you and your embryos We hope that this guide will give you a better understanding of the journey you and your embryos will take through our laboratory, and help you contribute

More information

East and North Hertfordshire CCG Fertility treatment and referral criteria for tertiary level assisted conception. December 2014

East and North Hertfordshire CCG Fertility treatment and referral criteria for tertiary level assisted conception. December 2014 East and North Hertfordshire CCG Fertility treatment and referral criteria for tertiary level assisted conception December 2014 1 1. Introduction This policy sets out the entitlement and service that will

More information

Ovarian Cyst. Homoeopathy Clinic. Introduction. Types of Ovarian Cysts. Contents. Case Reports. 21 August 2002

Ovarian Cyst. Homoeopathy Clinic. Introduction. Types of Ovarian Cysts. Contents. Case Reports. 21 August 2002 Case Reports 21 August 2002 Ovarian Cyst Homoeopathy Clinic Check Yourself If you have any of the following symptoms call your doctor. Sense of fullness or pressure or a dull ache in the abdomen Pain during

More information

Reduced Ovarian Reserve Is there any hope for a bad egg?

Reduced Ovarian Reserve Is there any hope for a bad egg? Reduced Ovarian Reserve Is there any hope for a bad egg? Dr. Phil Boyle Galway Clinic, 19 th March 2014 For more information on Low AMH see www.napro.ie Anti Mullerian Hormone AMH levels are commonly measured

More information

Abnormal Uterine Bleeding

Abnormal Uterine Bleeding Abnormal Uterine Bleeding WOMENCARE A Healthy Woman is a Powerful Woman (407) 898-1500 Abnormal uterine bleeding is one of the most common reasons women see their doctors. It can occur at any age and has

More information

injections injections injections injections injections injection injections injections injections tions njections injections injections injections

injections injections injections injections injections injection injections injections injections tions njections injections injections injections your guide to contraceptive Helping you choose the method of contraception that is best for you ions ections injection njections injection tions 2 Contraceptive Contraceptive contain a progestogen hormone

More information

Introduction Ovarian cysts are a very common female condition. An ovarian cyst is a fluid-filled sac on an ovary in the female reproductive system.

Introduction Ovarian cysts are a very common female condition. An ovarian cyst is a fluid-filled sac on an ovary in the female reproductive system. Ovarian Cysts Introduction Ovarian cysts are a very common female condition. An ovarian cyst is a fluid-filled sac on an ovary in the female reproductive system. Most women have ovarian cysts sometime

More information

Assignment Discovery Online Curriculum

Assignment Discovery Online Curriculum Assignment Discovery Online Curriculum Lesson title: In Vitro Fertilization Grade level: 9-12, with adaptation for younger students Subject area: Life Science Duration: Two class periods Objectives: Students

More information

Why is Cerazette used? To prevent pregnancy.

Why is Cerazette used? To prevent pregnancy. CERAZETTE Tablets for oral use Consumer Medicine Information What is in this leaflet Keep this leaflet. You may need to read it again. This leaflet will provide information about the benefits and risks

More information

OVULATION & INTRAUTERINE INSEMINATION (IUI)

OVULATION & INTRAUTERINE INSEMINATION (IUI) OVULATION & This handbook is intended to give you an overview of infertility treatment with IUI and ovulation induction and to better understand the medical circumstances that lead to this treatment option.

More information

Menstruation and the Menstrual Cycle

Menstruation and the Menstrual Cycle Menstruation and the Menstrual Cycle Q: What is menstruation? A: Menstruation (men-stray-shuhn) is a woman's monthly bleeding. When you menstruate, your body sheds the lining of the uterus (womb). Menstrual

More information

Uterine Fibroid Symptoms, Diagnosis and Treatment

Uterine Fibroid Symptoms, Diagnosis and Treatment Fibroids and IR Uterine Fibroid Symptoms, Diagnosis and Treatment Interventional radiologists use MRIs to determine if fibroids can be embolised, detect alternate causes for the symptoms and rule out misdiagnosis,

More information

Welcome to chapter 8. The following chapter is called "Monitoring IVF Cycle & Oocyte Retrieval". The author is Professor Jie Qiao.

Welcome to chapter 8. The following chapter is called Monitoring IVF Cycle & Oocyte Retrieval. The author is Professor Jie Qiao. Welcome to chapter 8. The following chapter is called "Monitoring IVF Cycle & Oocyte Retrieval". The author is Professor Jie Qiao. The learning objectives of this chapter are 2 fold. The first section

More information

Understanding Fertility

Understanding Fertility Understanding Fertility 6 Introduction The word fertile means the ability to become pregnant or to cause pregnancy. Basic knowledge of both the male and female reproductive systems is important for understanding

More information

Get the Facts Before You Decide!

Get the Facts Before You Decide! Get the Facts Before You Decide! The New York State Task Force on Life and the Law Advisory Group on Assisted Reproductive Technologies The New York State Task Force on Life and the Law was created in

More information

in vitro Fertilization (IVF)

in vitro Fertilization (IVF) Should an age limit be imposed on in vitro fertilization? Amanda Caster, Rong Hu, John Brothers II, and Barry Sexton Bioengineering and Bioinformatics Summer Institute 2005 University of Pittsburgh, Carnegie

More information

Egg Donation Process, Risk, Consent and Agreement

Egg Donation Process, Risk, Consent and Agreement Department of Obstetrics and Gynecology Strong Fertility Center Kathleen Hoeger, MD, MPH Director Bala Bhagavath, MD Vivian Lewis, MD John T. Queenan, Jr., MD Wendy Vitek, MD Egg Donation Process, Risk,

More information

Birth after previous caesarean. What are my choices for birth after a caesarean delivery?

Birth after previous caesarean. What are my choices for birth after a caesarean delivery? Birth after previous caesarean Information for you Published September 2008 What are my choices for birth after a caesarean delivery? More than one in five women (20%) in the UK currently give birth by

More information

Symposium on RECENT ADVANCES IN ASSISTED REPRODUCTIVE TECHNOLOGY

Symposium on RECENT ADVANCES IN ASSISTED REPRODUCTIVE TECHNOLOGY Symposium on RECENT ADVANCES IN ASSISTED REPRODUCTIVE TECHNOLOGY Dr Niel Senewirathne Senior Consultant of Obstetrician & Gynaecologist De zoyza Maternity Hospita 1 ART - IVF & ICSI 2 Infertility No pregnancy

More information

AGE & FERTILITY: Effective Evaluation & Treatment I. LANE WONG, MD, FACOG. www.hopefertilitycenter.com www.hopeivf.com

AGE & FERTILITY: Effective Evaluation & Treatment I. LANE WONG, MD, FACOG. www.hopefertilitycenter.com www.hopeivf.com Page 1 of 6 AGE & FERTILITY: Effective Evaluation & Treatment I. LANE WONG, MD, FACOG. www.hopefertilitycenter.com www.hopeivf.com Age has a profound effect on female fertility. This is common knowledge,

More information

the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD your guide to

the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD the IUD your guide to your guide to Helping you choose the method of contraception that is best for you IUD IUD the e IUD IU IUD the IUD 2 The intrauterine device (IUD) An IUD is a small plastic and copper device that is put

More information

ADVICE ON TRAVEL-RELATED DEEP VEIN THROMBOSIS

ADVICE ON TRAVEL-RELATED DEEP VEIN THROMBOSIS ADVICE ON TRAVEL-RELATED DEEP VEIN THROMBOSIS Introduction 1. A possible link between deep vein thrombosis (DVT) and long haul air travel was first suggested by reports in medical journals in the 1950s.

More information

INFORMED CONSENT AND AUTHORIZATION FOR IN VITRO FERTILIZATION OF PREVIOUSLY CRYOPRESERVED OOCYTES

INFORMED CONSENT AND AUTHORIZATION FOR IN VITRO FERTILIZATION OF PREVIOUSLY CRYOPRESERVED OOCYTES INFORMED CONSENT AND AUTHORIZATION FOR IN VITRO FERTILIZATION OF PREVIOUSLY CRYOPRESERVED OOCYTES We, the undersigned, as patient and partner understand that we will be undergoing one or more procedures

More information

Infertility Services Medical Policy For University of Vermont Medical Center and Central Vermont Medical Center employer groups

Infertility Services Medical Policy For University of Vermont Medical Center and Central Vermont Medical Center employer groups Infertility Services Medical Policy For University of Vermont Medical Center and Central Vermont Medical Center employer groups File name: Infertility Services File code: UM.REPRO.01 Last Review: 02/2016

More information