Long Term Follow Up Of Reproductive Outcomes In Fastt Participants.

To evaluate reproductive outcomes in couples who were enrolled in a large randomized controlled trial (RCT, FASTT1) that studied optimal treatment for unexplained infertility. Long term follow up of RCT participants. Between March 2019 and February 2020, a telephone survey was administered to women who had been enrolled in FASTT, an RCT conducted from 2001-2006 that evaluated optimal treatment for unexplained infertility in women ages 21-39 years (3 cycles of Clomiphene/IUI and 3 cycles of gonadotropin/IUI prior to proceeding to IVF) versus a fast track (3 cycles of Clomiphene/IUI before proceeding to IVF). All women enrolled in FASTT had a basal FSH <15 mIU/ml. Statistical analyses were performed using SAS v 9.2. Categorical variables were compared between groups using chi-square and Fisher’s exact tests and continuous variables with two-sample t-tests and analysis of variance with P<0.05 as significant. Of the 503 women originally enrolled in FASTT, 311 (61.8%) were contacted of whom 286 (56.9%) consented to participate in the survey. Mean age and mean FSH at enrollment in FASTT was 33.1 ± 3.2 years and 6.8 ± 2.2 mIU/ml respectively, for those who participated in the follow up survey. Mean age at follow-up was 49.5 ± 3.4 years. 194 (67.8%) women delivered a live birth during the trial and 225 (78.7%) continued to try to conceive after FASTT. There were a total of 360 clinical pregnancies, by all methods, with 251 (69.7%) live births. Of those who tried to spontaneously conceive (157), 101 (64.3%) had a successful live birth while a further 12 (5.3%) delivered a live birth via IUI and 82 (36.4%) via autologous oocyte IVF. Overall 182 women (80.9%) achieved a live birth following FASTT with a mean time to conception of 1.4 years (95% CI 1.2-1.6) following the trial. 113 women (77.4%) who had a live birth during FASTT had another live birth after, compared to 69 (87.3%) of those who hadn’t had a live birth during FASTT (P=0.08). A higher proportion of those who had a history of smoking did not achieve a live birth in FASTT compared to those who did not have a history of smoking (24/92, 26.1% vs 31/194, 16.0%, (P=0.05), however there was no difference between those who had a history of smoking and those who did not in terms of ever delivering a live birth (4/18, 22.2% vs 50/267, 18.7%, P=0.75. Controlling for age at enrollment to FASTT, a higher basal FSH was noted in those women who never had a live birth (7.9 ± 1.5 vs 6.6 ± 2.2, P=0.05). The time to conception after the trial for those who hadn’t had a live birth during the trial was 0.8 (95% CI 0.5-1.2) years compared to 1.6 years (95% CI 1.4-1.9) for those who had a live birth during the trial (P=0.01). The majority of couples in FASTT were able to achieve a live birth following the trial with a large proportion of those achieved spontaneously. Independent of age, those women who never had a live birth had a higher FSH at enrollment to FASTT.