Gillian Lockwood1, Georg Griesinger2, Barbara Cometti3. 1. Midland Fertility Services, Aldridge, United Kingdom. 2. University of Lübeck, Lübeck, Germany. 3. Institut Biochimique, Lugano, Switzerland. Electronic address: barbara.cometti@ibsa.ch.
Abstract
OBJECTIVE: To compare the safety, efficacy, and tolerability of subcutaneous progesterone (Prolutex, 25 mg; IBSA Institut Biochimique SA) with vaginal progesterone gel (Crinone, 8%; Merck Serono) for luteal phase support (LPS) in assisted reproduction technologies (ART) patients. DESIGN: Prospective, open-label, randomized, controlled, parallel-group, multicenter, two-arm, noninferiority study. SETTING:Thirteen European fertility clinics. PATIENT(S): A total of 683 ART patients randomized to two groups: Prolutex, 25 mg subcutaneously daily (n = 339); and Crinone, 90 mg 8% gel daily (n = 344). INTERVENTION(S): In vitro fertilization and embryo transfer were performed according to site-specific protocols. On the day of oocyte retrieval, Prolutex or Crinone gel was begun for LPS and continued for up to 10 weeks. MAIN OUTCOME MEASURE(S): Ongoing pregnancy rate. RESULT(S): The primary end point, ongoing pregnancy rates at 10 weeks of treatment were 27.4% and 30.5% in the Prolutex and Crinone groups, respectively (intention to treat [ITT]). The nonsignificant difference between the groups was -3.09% (95% confidence interval [CI] -9.91-3.73), indicating noninferiority of Prolutex to Crinone. Delivery and live birth rates resulted to be equivalent between the two treatments (26.8% vs. 29.9% in the Prolutex and Crinone groups, respectively [ITT]; difference -3.10 [95% CI -9.87-3.68]). No statistically significant differences were reported for any of the other secondary efficacy endpoints, including comfort of usage and overall satisfaction. CONCLUSION(S): Implantation rate, pregnancy rate, live birth rate, and early miscarriage rate for Prolutex were similar to those for Crinone. The adverse event profiles were similar and Prolutex was safe and well tolerated. CLINICAL TRIAL REGISTRATION NUMBER: NCT00827983.
RCT Entities:
OBJECTIVE: To compare the safety, efficacy, and tolerability of subcutaneous progesterone (Prolutex, 25 mg; IBSA Institut Biochimique SA) with vaginal progesterone gel (Crinone, 8%; Merck Serono) for luteal phase support (LPS) in assisted reproduction technologies (ART) patients. DESIGN: Prospective, open-label, randomized, controlled, parallel-group, multicenter, two-arm, noninferiority study. SETTING: Thirteen European fertility clinics. PATIENT(S): A total of 683 ART patients randomized to two groups: Prolutex, 25 mg subcutaneously daily (n = 339); and Crinone, 90 mg 8% gel daily (n = 344). INTERVENTION(S): In vitro fertilization and embryo transfer were performed according to site-specific protocols. On the day of oocyte retrieval, Prolutex or Crinone gel was begun for LPS and continued for up to 10 weeks. MAIN OUTCOME MEASURE(S): Ongoing pregnancy rate. RESULT(S): The primary end point, ongoing pregnancy rates at 10 weeks of treatment were 27.4% and 30.5% in the Prolutex and Crinone groups, respectively (intention to treat [ITT]). The nonsignificant difference between the groups was -3.09% (95% confidence interval [CI] -9.91-3.73), indicating noninferiority of Prolutex to Crinone. Delivery and live birth rates resulted to be equivalent between the two treatments (26.8% vs. 29.9% in the Prolutex and Crinone groups, respectively [ITT]; difference -3.10 [95% CI -9.87-3.68]). No statistically significant differences were reported for any of the other secondary efficacy endpoints, including comfort of usage and overall satisfaction. CONCLUSION(S): Implantation rate, pregnancy rate, live birth rate, and early miscarriage rate for Prolutex were similar to those for Crinone. The adverse event profiles were similar and Prolutex was safe and well tolerated. CLINICAL TRIAL REGISTRATION NUMBER: NCT00827983.
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: 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