OBJECTIVE: To compare the efficacy and safety of luteal phase support in IVF with a progesterone (P) vaginal ring or gel (VR or VG). DESIGN: Prospective, randomized, single-blind, multicenter, phase III clinical trial (ClinicalTrials.gov identifier: NCT00615251). SETTING:Nineteen private and three academic high-volume U.S. IVF centers. PATIENT(S): One thousand two hundred ninety-seven infertile patients were randomized to a weekly P VR (n = 646) or a daily P 8% VG (n = 651). INTERVENTION(S): IVF was performed per site-specific protocols. The day after egg retrieval, patients were randomized and began VR or VG therapy, which continued for up to 10 weeks' gestation. MAIN OUTCOME MEASURE(S): Clinical pregnancy rates at 8 and 12 weeks of pregnancy; rates of biochemical pregnancy, live birth, spontaneous abortion, ectopic pregnancy, and cycle cancellation; and safety and tolerability were secondary measures. RESULT(S): Clinical pregnancy rates at 8 and 12 weeks were high and comparable between groups: 48.0% for VR and 47.2% for VG at week 8 and 46.4% (VR) and 45.2% (VG) at week 12. Live-birth rates were 45% (VR) and 43% (VG). Adverse event profiles were similar between groups. CONCLUSION(S): The weekly P VR provided similar pregnancy rates to the daily VG, with no major differences in safety.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of luteal phase support in IVF with a progesterone (P) vaginal ring or gel (VR or VG). DESIGN: Prospective, randomized, single-blind, multicenter, phase III clinical trial (ClinicalTrials.gov identifier: NCT00615251). SETTING: Nineteen private and three academic high-volume U.S. IVF centers. PATIENT(S): One thousand two hundred ninety-seven infertilepatients were randomized to a weekly P VR (n = 646) or a daily P 8% VG (n = 651). INTERVENTION(S): IVF was performed per site-specific protocols. The day after egg retrieval, patients were randomized and began VR or VG therapy, which continued for up to 10 weeks' gestation. MAIN OUTCOME MEASURE(S): Clinical pregnancy rates at 8 and 12 weeks of pregnancy; rates of biochemical pregnancy, live birth, spontaneous abortion, ectopic pregnancy, and cycle cancellation; and safety and tolerability were secondary measures. RESULT(S): Clinical pregnancy rates at 8 and 12 weeks were high and comparable between groups: 48.0% for VR and 47.2% for VG at week 8 and 46.4% (VR) and 45.2% (VG) at week 12. Live-birth rates were 45% (VR) and 43% (VG). Adverse event profiles were similar between groups. CONCLUSION(S): The weekly P VR provided similar pregnancy rates to the daily VG, with no major differences in safety.
Authors: Matthew T Connell; Jennifer M Szatkowski; Nancy Terry; Alan H DeCherney; Anthony M Propst; Micah J Hill Journal: Fertil Steril Date: 2015-01-29 Impact factor: 7.329
Authors: Michelle van der Linden; Karen Buckingham; Cindy Farquhar; Jan A M Kremer; Mostafa Metwally Journal: Cochrane Database Syst Rev Date: 2015-07-07
Authors: Herman Weiss; Bridget Martell; Ginger D Constantine; Sarah M Davis; Justin D Vidal; Philip R Mayer; Martin Doorbar; David R Friend Journal: Drug Deliv Transl Res Date: 2019-10 Impact factor: 4.617
Authors: Aliyah Almomen; Sungpil Cho; Chieh-Hsiang Yang; Zhengzheng Li; Elke A Jarboe; C Matthew Peterson; Kang Moo Huh; Margit M Janát-Amsbury Journal: Pharm Res Date: 2015-01-22 Impact factor: 4.200
Authors: Valerie L Baker; Christopher A Jones; Kevin Doody; Russell Foulk; Bill Yee; G David Adamson; Barbara Cometti; Gary DeVane; Gary Hubert; Silvia Trevisan; Fred Hoehler; Clarence Jones; Michael Soules Journal: Hum Reprod Date: 2014-08-06 Impact factor: 6.918