Fast Track to IVF. Objectives

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1 Disclosure statement: Richard H. Reindollar, M.D. has no relevant financial relationships with any manufacturers of pharmaceuticals, laboratory supplies, or medical devices. Fast Track to IVF Richard H. Reindollar, M.D. Professor and Chair, Department of Obstetrics and Gynecology Dartmouth Medical School Dartmouth-Hitchcock Medical Center Objectives At the conclusion of this presentation the participant will: 1.Understand the rationale for a fast track approach for women with UI under and over age 40; 2.Discuss advantages and limitations for initiating treatment with clomiphene/iui in younger women; and 3.Consider why expectant management may or may not be reasonable.

2 Management of Unexplained Infertility Observation (+/-) Clomiphene/IUI (+/-) Gonadotropins/IUI (+/-) IVF Fast Track To IVF Observation? Clomiphene/IUI? Gonadotropins/IUI? IVF Fast Track to IVF: What Is It? (Based on FASTT Trial and Preliminary Data of FORT-T Trial) When couples meet the definition of infertility: For couples, women < 40 years: skip observation and gonadotropin/iui, after CC/IUI proceed to IVF (FASTT Trial) For couples, women > 38 years: immediate IVF (FORT-T Trial)

3 Two Large NIH sponsored Infertility Trials The Fast Track and Standard Treatment (FASTT) Trial NIH/NICHD R01 HD38561* The Forty and Over Infertility Treatment Trial (FORT-T) NIH/NICHD R01 HD (preliminary results) * Reindollar et al. Fertil Steril (3): Reindollar et al. Fertil Steril (3): p. S1. Study Characteristics Treatment Naive Met definition of unexplained infertility (FASTT, 1 year; FORT-T, 6 months) Age FASTT: < 40 th birthday, (mean age 33 yrs); FORT-T: 38 yr 43 rd birthday, (mean age 40.3 yrs) Normal ovarian reserve before and during trials: (FSH < 15 miu/ml, E2 < 100 pg/ml; FASTT CD 3, FORT-T CCT) Fast Track for Couples, female p, partner < 40 years

4 The FASTT Trial Hypothesis For couples with unexplained infertility, the female partner < 40 years, an accelerated track to IVF (omitting FSH/IUI) will result in a shorter time to pregnancy and at an estimated cost savings compared to conventional care. Treatment Arms Conventional Clomiphene 100 mg x 5 days/ 1 IUI* x 3 cycles 150 FSH IU x 5 days/ 1 IUI each cycle x 3 cycles Fast Track Clomiphene 100 mg x 5 days/ 1 IUI* x 3 cycles IVF x 6 cycles (Maximum 4 fresh cycles) IVF x 6 cycles (Maximum 4 fresh cycles) *LH Kit, US backup Clomiphene/IUI: Why Use OI/IUI At All? Computer simulation demonstrated no difference Computer simulation demonstrated no difference in cost for immediate IVF

5 Results FASTT CONSORT Flow Diagram Preliminary Screen for Eligibility n = 10,188 Randomized, n = 503 9/2001 8/2005 Conventional Protocol, n = 247 Fast-track to IVF Protocol, n = 256 Initiated Treatment Protocol, n = 243 Initiated Treatment Protocol, n = 250 Follow-up Per Protocol, n = 212 Follow-up Per Protocol, n = 236 Analyzed, n = 247 Analyzed, n = 256 Cycle Characteristics Conventional Fast Track Total Patients Randomized Patients With 1 Cycle 243 (98) 250 (98) 493 (98) Total CC/IUI Cycles Total FSH/IUI Cycles 439 Total IVF Cycles [Incl. Thaw Cycles] 261 [32] 361 [29] 622 [61] Total Cycles * NOTE 337 FEWER CYCLES IN FAST TRACK COMPARED TO CONVENTIONAL ARM

6 Sustained Pregnancy Rates Per Couple N pregnant couples (% pregnant) Conventional Fast Track All N/ total * (%) CC 45 (19) 53 (22) 98/475 (21) FSH 43 (25) - 43/169 (25) IVF 73 (66) 118 (69) 191/283 (68) Subtotal 161 (66) 171 (68) 332/493 (67) CIP 24 (10) 28 (11) 52/503 (10) Total 185 (75) 199 (78) 384/503 (76) * Total couples undergoing treatment; Cycle Independent Pregnancies Pregnancy Rates Per Treatment Cycle Initiated Rx (N cycles) CC/IUI (N = 1,294) FSH/IUI (N = 439) IVF (N = 622) Conventional Fast Track All All Sustained All Sustained All Sustained 55 (8.5) 45 (7.0) 68 (10.5) 53 (8.2) 123 (9.5) 98 (7.6) 50 (11.4) 43 (9.8) (11.4) 43 (9.8) 95 (36.4) 73 (28.0) 145 (40.2) 118 (32.7) 240 (38.6) 191 (30.7) Cumulative Incidence of Pregnancy HR=1.40 (95% CI ) P=0.03 Fast Track (n=256) median time to pregnancy 8 mo. Conventional (n=247) median time to pregnancy 11 mo. (Analysis using piecewise Cox proportional hazards model)

7 Total Charges Per Delivery Includes outpatient, inpatient, ER, and medication charges for women, and infant inpatient charges obtained from Insurance Companies. Arm Couples with a Couples Sum Total live birth delivery Charge Per N* Charges Delivery N Conventional 215 $9,424, $71,399 Fast Track 233 $9,606, $61,553 * Insurance data available for 448 (89%) of 503 couples Multiple Births of Sustained Pregnancies Conventional Fast Track CC FSH IVF Total CC IVF Total Twins 5(11) 7 (16)* 21 (29) 37 (20) 3(6) 37 (31) 42 (21) Triplets 0 1 (+1)* 0 1 (+1)* > Total 5 (11) 8 (19) 21 (29) 38 (21) 4 (8) 39 (33) 45 (22) * Includes 1 reduced from triplets; includes cycle independent (CIP) Unknown multiple status for 5 CIP and 1 IVF ongoing pregnancies Conclusions Gonadotropin /IUI treatment does not add value to a contemporary treatment paradigm An accelerated approach to IVF (that eliminates FSH/IUI but starts with CC/IUI) results in an equivalent percentage of pregnancies with: a 40% increased rate of pregnancy (between 3 and 11 months of treatment) that is statistically significant; fewer treatment cycles; and, at an estimated lower cost. IVF would have to cost $17,749 for conventional treatment to have a lower cost per delivery than accelerated therapy

8 Fast Track for Couples, female partner < 40 years Clomiphene/IUI (~ 3 cycles) IVF Clomiphene/IUI: Why Include It? Computer simulation demonstrated no difference in cost for immediate IVF Clomiphene / IUI (with normal stimulation and no cancellation of cycles) allows the most fertile couples with the highest chance for multiples to become pregnant with a treatment that has a low chance for multiples before IVF Fast Track for Couples, female partner > 38 years (Preliminary Data of FORT-T Trial)

9 The FORT-T Trial Hypothesis Immediate IVF is a more effective treatment strategy for reproductively older women who demonstrate a reasonable chance for success than are treatments that begin with superovulation/iui. Treatment Arms *LH Kit, US unless they fail to demonstrate a reasonable chance for success: 2 cycles cancelled or for which embryo criteria not met FORT-T Consort Flow Diagram

10 Cycle Characteristics CC/IUI ARM FSH/IUI ARM IVF ARM Total Patients Randomized Patients With 1 Cycle 45 (88.2) 48 (92.3) 47 (92.2) 140 CC/IUI Cycles (17.9) FSH/IUI Cycles (18.9) 1 st 2 IVF Cycles (17.5) Total IVF Cycles [Incl. Thaw Cycles] (63.2) Total Cycles * 487 * Represents 36% fewer cycles than in either of the 2 arms Clinical And Live Born Pregnancy Rates Per Treatment Cycle Initiated 1 st 2 Cycles/Arm N pregnant couples (% pregnant) Clinical Live Born CC/IUI FSH/IUI IVF (n=87 cycles) (n=91 cycles) (n=85 cycles) 6 (6.9)* 7 (7.7)* 21 (24.7)* 13 (7.3)** 21 (24.7)** 3(3.4) 6 (6.6) 13(15.3) 9 (5.1) 13 (15.3) *p=0.004 ; ** p= p=0.03; p=0.017 Clinical And Live Born Pregnancy Rates Per Couple 1 st 2 Cycles/Arm N pregnant couples (% pregnant) CC/IUI FSH/IUI IVF (n=51) (n=52) (n=51) Clinical 6 (11.7)* 7 (13.5)* 21 (41.2)* 13 (12.6)** 21 (41.2)** Live Born 3 (5.9) 6 (11.5) 13 (25.5) 9 (8.7) 13 (25.5) *p=0.002; **p<0.001 p=0.02; p=0.01

11 Live Born Pregnancy Rates Per Couple All Cycles N pregnant couples (% pregnant) CC/IUI (n=51) FSH/IUI (n=52) IVF (n=51) All (n=154) CC 3 (5.9) 3 (1.9) FSH 6 (11.5) 6 (3.9) IVF 15 (29.4) 15 (28.8) 18 (35.3) 48 (31.2) Subtotal 18 (35.2) 21 (40.4) 18 (35.3) 57 (37.0) CIP 7 (13.7) 1 (1.9) 6 (11.8) 14 (9.1) Total 25 (49.0) 22 (42.3) 24 (47.1) 71 (46.1) Cycle Independent Pregnancies in Arm Note: 83% of CC/IUI, 71% of FSH/IUI and 84% of all RX related pregnancies were from IVF. Average Number of Rx Cycles Per Live Born Pregnancy (LB) Per Arm Rx Related LB All LB (Inc CIP) CC/IUI Arm FSH/IUI Arm Immediate IVF Arm 34±1 3.4±1.5* 5*(18 LB) 33±1 3.3±1.9* 9*(21 LB) 19±0 1.9±0.8* 8*(18 LB) (3,3,4) (2,3,4) (1,2,3) 2.7±1.9** (25 LB) (1,3,4) 3.1±2.0** (22 LB) 1.8±1.1** (24 LB) (2,3,4) (1,2,3) (25% le, 50% le, 75% le); * p=0.004; ** p=0.03 Randomization Arms Multiple Births of Live Born Pregnancies Treatment Cycles Clinical Pregnancies Live Birth Pregnancies Multiples CC/IUI First FSH/IUI randomized treatment IVF cycles * Note: all multiples are twins except one set (*) of IVF live birth triplets Addi onal independent mul ple birth prior to ini a ng randomized treatment (not counted here) Total Multiples / Live Births 5 /22 (22.7) All Arms Subsequent IVF treatment /35 (20.0) cycles Total (21.1)

12 Conclusions For treatment naïve couples who present with unexplained infertility at the end of reproductive years and who demonstrate a reasonable chance for success: Beginning treatment with immediate IVF, compared to initial treatments of SO/IUI, results in a significantly higher number of live born infants and with significantly more couples pregnant, during the initial cycles of treatment. Couples who begin treatment with SO/IUI and then, if not pregnant, proceed through an appropriate number of IVF cycles will have a similar live born pregnancy rate compared to couples whose treatment was only IVF, but- will go through significantly more treatment cycles, and the majority of their infants will be conceived through IVF. Immediate IVF is the most effective treatment for couples, the female partner at the end of reproductive years, who demonstrate a reasonable chance for success. Fast Track for Couples, female partner > 38 years Immediate IVF

13 Fast Track < 40 Fast Track > 38 Observation Clomiphene/IUI Immediate IVF Gonadotropins/IUI IVF Reindollar et al. Fertil Steril (3): Reindollar et al. Fertil Steril (3): p. S1. Questions to be Addressed Why not observation first? Why clomiphene/iui in younger couples? Why Exclude Observation? Clomiphene/IUI success in FASTT > reported success from no RX 7.6% vs. 2 4% (OPR vs. PR) Studies with observation arms, nearly all European, are mostly designed such that effectiveness of Rx is limited: COH not to be of significant influence.patients are stimulated rather mildly and mono or bifollicular cycles are quite common (Custers et al. Hum Reprod. 2008;23:885) Rx cycles are often cancelled (more chance for pregnancy in control cycles) The standard of care in US has moved beyond equipoise For the older patients, waiting may prevent any pregnancy the average age of the last pregnancy is just before 41 st birthday.

14 References 1. Reindollar et al. A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial. Fertility and Sterility, (3): Reindollar et al. A randomized clinical trial to determine optimal infertility therapy in couples when the female partner is years: preliminary results from the forty and over infertility treatment trial (FORT-T). Fertility and Sterility, (3):S1. 3. Guzick et al. Efficacy of superovulation and intrauterine insemination in the treatment of infertility. National Cooperative Reproductive Medicine Network. N Engl J Med, (3): References (cont.) 4. Custers et al. Intrauterine insemination: how many cycles should we perform? Hum Reprod, (4): Steures et al. Intrauterine insemination with controlled ovarian hyperstimulation versus expectant management for couples with unexplained subfertility and an intermediate prognosis: a randomised d clinical i l trial. Lancet, (9531):

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