A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)
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)
1 other identifier
interventional
238
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2004
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedJuly 31, 2014
March 1, 2010
March 4, 2010
July 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Crinone 8% group
EXPERIMENTALFemale subjects undergoing IVF/ET treated with Crinone 8% intravaginally
Intramuscular progesterone group
ACTIVE COMPARATORFemale subjects undergoing IVF/ET treated with 60 mg progesterone intramuscularly once daily
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Habitual abortion
- Hydrosalpinges
- History of past poor response to COH
- Patients with serious arterial, lung, hepatic and renal diseases
- Hepatic and renal impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University 3rd Hopistal
Beijing, 100191, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Huafei Li
Serono Pharmaceutical Limited
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
May 1, 2004
Study Completion
May 1, 2005
Last Updated
July 31, 2014
Record last verified: 2010-03