口服黃體素Duphaston (30mg/d) vs 陰道塞劑黃體素(crinone)
對於IVF-ET無統計差異

Hum Reprod. 2018 Dec 1;33(12):2212-2221. doi: 10.1093/humrep/dey306.

Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial.

Griesinger G1, Blockeel C2, Sukhikh GT3, Patki A4, Dhorepatil B5, Yang DZ6, Chen ZJ7, Kahler E8, Pexman-Fieth C9, Tournaye H2.

Author information

Abstract

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 IVFcenters in 10 countries worldwide, from August 2015 until May 2017. In total, 1034 premenopausal women (>18 to <42 years of age) undergoing IVF were randomized 1:1 (stratified by country and age group), using an Interactive Web Response System, to receive oraldydrogesterone 30 mg or 8% MVP gel 90 mg daily.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Subjects received either oral dydrogesterone (n = 520) or MVP gel (n = 514) on the day of oocyte retrieval, and luteal phase support continued until 12 weeks of gestation. The primary outcome measure was the presence of fetal heartbeats at 12 weeks of gestation, as determined by transvaginal ultrasound.

MAIN RESULTS AND THE ROLE OF CHANCE:

Non-inferiority of oral dydrogesterone was demonstrated, with pregnancy rates in the full analysis sample (FAS) at 12 weeks of gestation of 38.7% (191/494) and 35.0% (171/489) in the oral dydrogesterone and MVP gel groups, respectively (adjusted difference, 3.7%; 95% CI: -2.3 to 9.7). Live birth rates in the FAS of 34.4% (170/494) and 32.5% (159/489) were obtained for the oral dydrogesterone and MVP gel groups, respectively (adjusted difference 1.9%; 95% CI: -4.0 to 7.8). Oral dydrogesteronewas well tolerated and had a similar safety profile to MVP gel.