A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)
- Registration Number
- NCT01081652
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- Brief Summary
This was an open-label, randomized, comparative, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular (i.m.) administered once a day in luteal phase support in 200 Chinese female subjects undergoing IVF/ET.
- Detailed Description
This was an open-label, randomized, comparative, multicentric, phase III study to evaluate the safety and efficacy of Crinone 8% in comparison with progesterone 60 mg intramuscular administered once a day in luteal phase support in Chinese female subjects undergoing IVF/ET. The study planned to enroll 200 female subjects who underwent pituitary down-regulation as per each center's normal practice prior to and during stimulation of multiple follicular development. The progesterone administration was started on the day of ET. Randomisation was performed on the day of ET. If pregnancy was confirmed on day 14 of the progesterone administration, the progesterone was continued for another 45 days. The subjects were followed up and the treatment outcome (negative pregnancy test or pregnancy) was recorded.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 238
- Patient has given written informed consent
- BMI < 25 kg/m2
- Age < 36 years
- <3 prior ART cycles (IVF, ICSI and related procedures)
- Infertility
- Regular spontaneous ovulatory menstrual cycles
- Habitual abortion
- Hydrosalpinges
- History of past poor response to COH
- Patients with serious arterial, lung, hepatic and renal diseases
- Hepatic and renal impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intramuscular progesterone group Progesterone Female subjects undergoing IVF/ET treated with 60 mg progesterone intramuscularly once daily Crinone 8% group Micronised Progesterone Female subjects undergoing IVF/ET treated with Crinone 8% intravaginally
- Primary Outcome Measures
Name Time Method The difference in hCG positive rate in the two arms 14 days after embryo transfer The difference in pregnancy rates in the two arms 30 and 60 days after embryo transfer The difference in implantation rate in the two arms 30 days after embryo transfer
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking University 3rd Hopistal
🇨🇳Beijing, China