An Open, Randomized, Comparative, Phase III Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilization and Embryo Transfer (IVF/ET)
Overview
- Phase
- Phase 3
- Intervention
- Micronised Progesterone
- Conditions
- Infertility
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Enrollment
- 238
- Locations
- 1
- Primary Endpoint
- The difference in hCG positive rate in the two arms 14 days after embryo transfer
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Habitual abortion
- •Hydrosalpinges
- •History of past poor response to COH
- •Patients with serious arterial, lung, hepatic and renal diseases
- •Hepatic and renal impairment
Arms & Interventions
Crinone 8% group
Female subjects undergoing IVF/ET treated with Crinone 8% intravaginally
Intervention: Micronised Progesterone
Intramuscular progesterone group
Female subjects undergoing IVF/ET treated with 60 mg progesterone intramuscularly once daily
Intervention: Progesterone
Outcomes
Primary Outcomes
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