Endometrin for luteal phase support in a randomized, controlled, open-label, prospective in-vitro fertilization trial using a combination of Menopur and Bravelle for controlled ovarian hyperstimulation
Received 25 November 2007; received in revised form 17 January 2008; accepted 17 January 2008. published online 27 March 2008.
Objective
To assess the efficacy and safety of a vaginal progesterone (P4) insert (Endometrin) for luteal support for assisted reproductive technology (ART).
Design
Multicenter, randomized, open-label (assessor-blinded) phase III clinical trial.
Setting
Twenty-five U.S. ART centers.
Patient(s)
A total of 1,211 ART patients randomized to three groups: Endometrin 100 mg twice daily (n = 404), Endometrin 100 mg three times daily (n = 404), and P4 90 mg 8% gel daily (n = 403).
Intervention(s)
In vitro fertilization and ET were performed according to site-specific protocols. The day after oocyte retrieval, Endometrin or vaginal P4 gel was begun for luteal support and continued for up to 10 weeks of pregnancy.
Main Outcome Measure(s)
Biochemical, clinical, and ongoing pregnancy and live birth rates.
Result(s)
Pregnancy rates were high and similar in all treatment groups, with biochemical rates exceeding 50%, clinical and ongoing rates ≥40%, and live birth rates at 35%–38%. The adverse event profiles were similar across groups.
Conclusion(s)
Pregnancy rates and live birth rates for Endometrin (twice daily and three times daily) were high and similar to those for P4 gel. The adverse event profiles for both were similar to that for P4 gel and primarily due to IVF stimulation and oocyte retrieval. Endometrin was safe and well tolerated.
E.J.B. and V.I.Y are employees of Ferring Pharmaceuticals. C.E.M. receives grant support from Ferring Pharmaceuticals, acts as a consultant for Ferring Pharmaceuticals, Ethicon Endo Surgery, Ethicon Women's Health and Urology, Smith & Nephew, Galil Medical, and Boston Scientific, and serves on speakers bureaus for Boston Scientific, Ferring Pharmaceuticals, Ethicon Endo Surgery, and Ethicon Women's Health and Urology. K.J.D. has nothing to disclose. V.L.S. has nothing to disclose. R.A.F. has nothing to disclose. B.A.K. has nothing to disclose.
ABSTRACT