Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF
Autor: | Georg Griesinger, Elke Kahler, Herman Tournaye, Bharati Dhorepatil, Christophe Blockeel, Zi-Jiang Chen, Claire Pexman-Fieth, Ameet Patki, Gennady T. Sukhikh, D. Yang |
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Přispěvatelé: | Surgical clinical sciences, Reproduction and Genetics, Centre for Reproductive Medicine - Gynaecology, Biology of the Testis |
Jazyk: | angličtina |
Rok vydání: | 2018 |
Předmět: |
Adult
0301 basic medicine medicine.medical_specialty Pregnancy Rate Administration Oral Oocyte Retrieval Micronized vaginal progesterone gel Fertilization in Vitro Luteal Phase Dydrogesterone Luteal phase Placebo law.invention 03 medical and health sciences 0302 clinical medicine luteal phase support Ovulation Induction Randomized controlled trial Pregnancy law Obstetrics and Gynaecology medicine Humans Progesterone 030219 obstetrics & reproductive medicine Obstetrics business.industry Rehabilitation Obstetrics and Gynecology medicine.disease dydrogesterone Administration Intravaginal Pregnancy rate Treatment Outcome 030104 developmental biology Tolerability IVF Infertility Original Article Female Randomized clinical trial business Live birth medicine.drug reproductive medicine |
Zdroj: | Human Reproduction (Oxford, England) |
DOI: | 10.1093/humrep/dey306 |
Popis: | STUDY QUESTION: Is oral dydrogesterone 30 mg daily non-inferior to 8% micronized vaginal progesterone (MVP) gel 90 mg daily for luteal phase support in IVF? SUMMARY ANSWER: Oral dydrogesterone demonstrated non-inferiority to MVP gel for the presence of fetal heartbeats at 12 weeks of gestation (non-inferiority margin 10%). WHAT IS KNOWN ALREADY: The standard of care for luteal phase support in IVF is the use of MVP; however, it is associated with vaginal irritation, discharge and poor patient compliance. Oral dydrogesterone may replace MVP as the standard of care if it is found to be efficacious with an acceptable safety profile. STUDY DESIGN, SIZE, DURATION: Lotus II was a randomized, open-label, multicenter, Phase III, non-inferiority study conducted at 37 IVF centers in 10 countries worldwide, from August 2015 until May 2017. In total, 1034 premenopausal women (>18 to |
Databáze: | OpenAIRE |
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