A randomized clinical trial to determine optimal infertility treatment in older couples: the Forty and Over Treatment Trial (FORT-T)

Abstract

Objective To determine optimal infertility therapy in women at the end of their reproductive potential. Design Randomized clinical trial. Setting Academic medical centers and private infertility center in a state with mandated insurance coverage. Patients Couples with ≥ 6 months of unexplained infertility; female partner aged 38–42. Interventions Randomized to treatment with 2 cycles of clomiphene citrate (CC) and intrauterine insemination (IUI), follicle stimulating hormone (FSH)/IUI, or immediate IVF, followed by IVF if not pregnant. Main Outcome Measures Proportion with a clinically recognized pregnancy, number of treatment cycles, and time to conception after 2 treatment cycles and at the end of treatment. Results 154 couples were randomized to receive CC/IUI (N=51), FSH/IUI (N=52), or immediate IVF (N=51); 140 (90.9%) couples initiated treatment. Cumulative clinical pregnancy rates per couple after the first 2 cycles of CC/IUI, FSH/IUI, or immediate IVF were 21.6%, 17.3%, and 49.0%, respectively. After all treatment, 71.4% (110/154) of couples conceived a clinically recognized pregnancy and 46.1% delivered at least one live-born baby. 84.2% of all live born infants resulting from treatment were achieved from IVF. There were 36% fewer treatment cycles in the IVF arm compared to either COH/IUI arm and couples conceived a pregnancy leading to a live birth after fewer treatment cycles. Conclusions An RCT to compare treatment initiated with 2 cycles of COH/IUI to immediate IVF in older women with unexplained infertility demonstrated superior pregnancy rates with fewer treatment cycles in the immediate IVF group.

A comparison on the Intrauterine Insemination Outcomes of Infertile Women Undergoing Ovulation Induction with Clomiphene Citrate and rFSH

“…Çalışmamızda rFSH + IUI uygulanan gruptaki kadınlarda gerçekleşen gebelik oranı %16, klomifen sitrat + IUI uygulanan gruptaki kadınlarda ise %15.5 olup, her iki grup arasında anlamlı fark saptanmadı. Yapılan çalışmalarda, IUI uygulanan sikluslarda klomifen sitrat ve rFSH kullanımı ile gerçekleşen gebelik oranları karşılaştırılmış, her iki grupta da siklus başına devam eden gebelik oranları arasında fark bulunamamıştır (11,12). Yapılan bir derlemede klomifen sitrat ile birlikte IUI uygulananlarda, doğal sikluslarda planlanmış cinsel ilişkilere göre daha yüksek oranda gebelik olduğu bildirilmiştir (13).…”

Oral Drugs for Unexplained Infertility

“…Goldman et al [28] set up an elegant randomized clinical trial to determine the optimal infertility therapy for women with unexplained infertility at the end of their reproductive potential. Couples with C6 months of unexplained infertility with female partner aged 38-42 years were included.…”

“…There were 36 % fewer treatment cycles in the IVF arm compared with either COH/IUI arm, and the couples conceived a pregnancy leading to a live birth after fewer treatment cycles. This paper suggested that a randomized controlled trial in older women with unexplained infertility to compare treatment initiated with two cycles of controlled ovarian hyperstimulation/IUI versus immediate IVF demonstrated superior pregnancy rates with fewer treatment cycles in the immediate IVF group [28].…”

Prendre en charge les femmes de 40ans et plus en FIV : pour ou contre ou pour et contre ?

“…Les auteurs concluent que la stimulation de l'ovulation ou la MIV font perdre inutilement du temps aux femmes. En 2014, Goldman, dans une é tude randomisé e, a confirmé la supé riorité de la FIV directe en comparant l'efficacité de 2 cycles de clomifè ne +IIU ou de FSH +IIU, puis FIV aprè s é chec ou de la FIV d'emblé e et rapporté des taux cumulatifs de grossesse de 21,6 et 17,3 % contre 49 % en cas de FIV d'emblé e [28]. La FIV d'emblé e semble donc la thé rapeutique la plus efficace.…”