Frequently Asked Questions

Transcription

1 What does the product do? The Stork by Rinovum Women s Health bridges the gap between natural intercourse and more aggressive, costly treatments, like IUI or IVF. The Stork is a home conception kit that uses cervical cap insemination as an aid to conception. The Stork collects semen through natural intercourse with a condom-like sheath, the Conceptacle, then delivers it to the outside of the cervix using an applicator. Who should use The Stork? People that are trying to become pregnant. Men diagnosed with low sperm count or motility issues. Couples trying to become pregnant without intercourse. Healthy couples who desire to control timing. Couples who are not ready to take the next-step of more aggressive reproductive treatment options (i.e. IUI, IVF). What is a cervical cap? Historically, cervical caps have been used for both conception and contraception dating back to the 1950 s. Doctors have used cervical caps for insemination with great success rates. The Stork uses this technique adding a special applicator to improve the delivery method of the cervical cap to the cervical os. What are the indications for use? The Stork is indicated for assisted insemination by couples who are trying to become pregnant. The Stork contains a cervical cap inside a condom-like silicone sheath and an applicator. It is used to collect semen into a cervical cap then deliver it outside of the cervix as an aid to conception. The Stork cervical cap should not be left in place for longer than 6 hours. Where can I get The Stork? For information on where to purchase The Stork, please visit the website [From May 2014, The Stork will be available to purchase from Superdrug.com.] How long should I use The Stork before speaking with my healthcare professional about other options? You should always speak to your healthcare professional about any concerns or queries relating to your fertility. The suggested use period for The Stork is 3-6 months, on the 3 most fertile days of the female partner s cycle. How long after placing the cervical cap do I have to wait before returning to normal activities? You and your partner can return to normal activities immediately after placing the cervical cap and removing the applicator. You should not have sexual intercourse while the cervical cap is inserted as it may cause discomfort to you or your partner. Rinovum 2014: , Rev. 02 PG.1

2 How long should I keep the cervical cap in place? The cervical cap should remain in place for no more than 6 hours. Remove the cervical cap after 4-6 hours. Failure to remove the cervical cap could result in complications, including obstruction of physiological discharge and menstrual flow from the uterus, pain, abrasion/ulceration and/or infection. Can The Stork be used with fertility medications? Yes, there are currently no contraindications for the use of fertility medications and cervical cap insemination. However, please speak with your healthcare professional regarding taking fertility medications if you plan to use The Stork. Does the Conceptacle contain latex? No, the Conceptacle is made of silicone and does not contain latex. Can the device be reused? No, each device is designed for single-use only. None of The Stork parts should be reused or shared. Reuse of the device may result in an infection, which may endanger future fertility. Can I use a regular condom with the applicator provided? Use only the Conceptacle (the condom-like sheath with the cervical cap inside) provided in the Stork packaging. Other condoms may contain latex or spermicide which could kill sperm and impede your conception chances. Can I use a lubricant or moisturiser with the product? If partners wish to use an intimate moisturiser, make sure to use a sperm-friendly one. Most intimate moisturisers are harmful to sperm. Why does the cervical cap only come in one size? The cap was designed for both women who have delivered before and women who have not. The cap was designed to accommodate both, and since the cervix sizes of both are very similar, the cap will fit both. Rinovum 2014: , Rev. 02 PG.2

3 Does The Stork protect against HIV or other sexually transmitted diseases? No, The Stork does not protect against HIV or STDs. Do not use semen from a partner who has HIV or other sexually transmitted diseases. To avoid HIV or STDs DO NOT share The Stork. Are there any known complications or adverse reactions associated with using the device? There are no publications that discuss whether cervical cap usage can cause TSS (toxic shock syndrome). The Instructions for Use instruct the user to remove the cap four to six hours after insertion to reduce the risk of TSS. The risk of TSS exists for products like tampons and other vaginal devices. TSS is a rare but serious disease that may cause death. Warning signs of TSS include sudden fever (usually 39 C/102 F or more) and vomiting, diarrhoea, fainting or near fainting when standing up, dizziness, or a rash that looks like a sunburn. If these or other signs of TSS appear, remove the cervical cap at once, and seek medical attention immediately. The Stork is intended to assist you in becoming pregnant. Pregnancy may involve serious health risks for both you and your unborn child. Consult your healthcare professional for possible risks before using The Stork. Is there any chance of contamination during packaging? The product is packaged in a medically clean room. To avoid contamination, customers are advised not to open or handle the device until they are ready to use it. The product is non-sterile. Are there any health conditions that prevent people from using this device? The device is not to be used by those for whom it is medically unsafe to engage in sexual intercourse or to become pregnant. If I have any questions regarding fertility issues who should I contact? If you have any questions regarding fertility issues, please contact your healthcare professional. If I have any issues with using The Stork whom do I contact? Ceuta Healthcare Customer Serv ices Hill House 41 Richmond Hill Bournemouth BH2 6H customerservices@ceutahealthcare.com Rinovum 2013: , Rev. 02 PG.3

4 Healthcare Professional What technology does the product compete with or replace? The Stork by Rinovum Women s Health bridges the gap between natural intercourse and more aggressive, costly treatments. The Stork utilizes cervical cap insemination, giving couples the ability to use this technique in the privacy of home. It is a more natural first-step in assisted reproductive treatments for a couple who is not ready to take the next step of IUI or IVF. The Stork can be used in conjunction with other ovulation/fertility monitor products or on its own to improve the chances of conception. Who should use The Stork? People that are trying to become pregnant. Men diagnosed with low sperm count or motility issues. Patients trying to become pregnant without intercourse. Patients who desire to control timing. Patients who seek out private options for trying to conceive or at-home insemination options. What are the indications for use? The Stork is indicated for home use assisted insemination by couples who are trying to become pregnant. The Stork contains a cervical cap inside a condom-like silicone sheath and an applicator. It is used to collect semen into a cervical cap then deliver it outside of the cervix as an aid to conception. The Stork cervical cap should not be left in place for longer than 6 hours. What is a cervical cap? Historically, cervical caps have been used for both conception and contraception dating back to the 1950 s. Doctors used cervical caps for insemination with great success rates (see journal articles below). The Stork brings back that technique adding a special applicator to improve the delivery method of the cervical cap to the cervical os. Are there any known complications or adverse reactions with using the device? There were no complications found during clinical studies. There are no publications that discuss whether cap usage can cause TSS (toxic shock syndrome). The instructions for use instruct the patient to remove the cap four to six hours after insertion to reduce the risk of TSS. Is there any chance for contamination during packaging? The product is packaged in a medical clean room. To avoid contamination, customers are advised not to open or handle the device until they are ready to use it.the product is non-sterile. Evaluation of the effect of a cervical cap device on sperm functional characteristics in vitro, ANDROLOGIA 33, (2001), M. C. Mahony. Artificial insemination with fresh donor semen using the cervical cap technique: a review of 278 cases, Obstet Gynecol Aug;60(2):195-9, Bergquist CA, Rock JA, Miller J, Guzick DS, Wentz AC, Jones GS. Randomized controlled trial of cervical cap with intracervical reservoir versus standard intracervical injection to inseminate cryopreserved donor sperm, Human Reproduction, Vol. 11, no.1, pp.84-87, 1996, C. Coulson, E.A. McLaughlin, S. Harris, W.C.L. Ford and M.G.R. Hull. Cervical Cap Homologous Artificial Insemination: Noci I, Chelo E, Scarselli G, Messori A. Cervical cap homologous artificial insemination (AIH): the University of Florence experience. Acta Eur Fertil Mar-Apr;17(2): A Prospective, randomized, cross-over comparison of two methods of artificial insemination by donor on the incidence of conception: Intracervical insemination by straw versus cervical cap, Human Reproduction, Vol. 12, no , 1997, Flierman, Hendrikus, et al. Rinovum 2014: , Rev. 02

5 Healthcare Professional Are there any health conditions that prevent patients from using this device? The device is not to be used by those patients for whom it is medically unsafe to engage in sexual intercourse or to become pregnant. What is the recommended amount of time that a patient should use The Stork? Three to six months of use on the female patient s three most fertile days of her cycle. After six months of use, the patients are advised to speak with their physician about another treatment option. Can the device be reused? No, each device is designed for single-use only. Can The Stork be used while on fertility medications? Yes, there are currently no contra-indications for the use of fertility medications and cervical cap insemination. How long after placing the cervical cap does the user have to wait before returning to normal activities? The patient can return to normal activities immediately after placing the cervical cap and removing the applicator. Patients should not have sexual intercourse while the cervical cap is inserted as it may cause discomfort. The patient is instructed to remove the cervical cap four to six hours after placing the cap. If there is an adverse event whom do I contact? Ceuta Healthcare Customer Services Hill House 41 Richmond Hill Bournemouth BH2 6HS customerservices@ceutahealthcare.com Rinovum 2014: , Rev. 02