Journal article
Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: a noninferiority randomized controlled study
Fertility and Sterility, Vol.101(1), pp.112-119.e3
01/2014
DOI: 10.1016/j.fertnstert.2013.09.010
PMID: 24140033
Abstract
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. Prospective, open-label, randomized, controlled, parallel-group, multicenter, two-arm, noninferiority study. Thirteen European fertility clinics. 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). 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. Ongoing pregnancy rate. 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. 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. NCT00827983.
Details
- Title: Subtitle
- Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: a noninferiority randomized controlled study
- Creators
- Gillian Lockwood - Midland Fertility Services, Aldridge, United KingdomGeorg Griesinger - University of Lübeck, Lübeck, GermanyBarbara Cometti - Institut Biochimique, Lugano, SwitzerlandGiuseppe de PlacidoCarlo AlviggiAntonio RanieriIda StrinaEnrico PapaleoMichela MolgoraAndrea R GenazzaniPaolo ArtiniVito CelaNicola PluchinoAnnibale VolpeAntonio la MarcaGiovanna SighinolgiKlaus Diedrich - Klinik für Frauenheilk und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, GermanyLuca GianaroliChristina GrugnettiChristian de Geyter - Clinic of Gynecologic Endocrinology and Reproductive Medicine, University of Basel, Basel, SwitzerlandJanos Urbancsek - First Department of Obstetrics and Gynecology, Semmelweis University Faculty of Medicine, Budapest, HungaryAbey Eapen - Midland Fertility Services, Aldridge, United KingdomGuido Ragni - Unità Ospedaliera Semplice Dipartimentale Centro Sterilità, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ospedale Policlinico, Mangiagalli, MilanoYacoub Khalaf - Guy's and St. Thomas' Hospital, London, United KingdomLuca Sabatini - Centre for Reproductive Medicine, St. Bartholomew's Hospital, London, United KingdomBruno Engl - Unità Ospedaliera di Ginecologia e Ostetricia, Ospedale Civico, Brunico, Italy13 European Centers
- Resource Type
- Journal article
- Publication Details
- Fertility and Sterility, Vol.101(1), pp.112-119.e3
- DOI
- 10.1016/j.fertnstert.2013.09.010
- PMID
- 24140033
- NLM abbreviation
- Fertil Steril
- ISSN
- 0015-0282
- eISSN
- 1556-5653
- Publisher
- Elsevier Inc
- Grant note
- Ferring Kade Besins MSD Institut Biochimique Merck Serono
- Language
- English
- Date published
- 01/2014
- Academic Unit
- Obstetrics and Gynecology
- Record Identifier
- 9983930281502771
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