A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Infertility

Intervention / Treatment
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* Drug: Micronised Progesterone
* Drug: Progesterone


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crinone 8% group<br>Female subjects undergoing IVF/ET treated with Crinone 8% intravaginally | Drug: Micronised Progesterone<br>* Micronised progesterone administered intravaginally once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.<br>* Other names: Crinone 8%;|
| Active Comparator: Intramuscular progesterone group<br>Female subjects undergoing IVF/ET treated with 60 mg progesterone intramuscularly once daily | Drug: Progesterone<br>* Progesterone 60 mg administered intramuscular once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fertilisation, In vitro, Embryo transfer, progesterone, Reproductive technologies, Assisted