Back to resultsA Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Micronised Progesterone
Progesterone
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Fertilisation, In vitro, Embryo transfer, progesterone, Reproductive technologies, Assisted
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
Sites / Locations
- Peking University 3rd Hopistal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Crinone 8% group
Intramuscular progesterone group
Arm Description
Female subjects undergoing IVF/ET treated with Crinone 8% intravaginally
Female subjects undergoing IVF/ET treated with 60 mg progesterone intramuscularly once daily
Outcomes
Primary Outcome Measures
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
Full Information
NCT ID
NCT01081652
First Posted
March 4, 2010
Last Updated
July 30, 2014
Sponsor
Merck KGaA, Darmstadt, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01081652
Brief Title
A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Merck KGaA, Darmstadt, Germany
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Fertilisation, In vitro, Embryo transfer, progesterone, Reproductive technologies, Assisted
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crinone 8% group
Arm Type
Experimental
Arm Description
Female subjects undergoing IVF/ET treated with Crinone 8% intravaginally
Arm Title
Intramuscular progesterone group
Arm Type
Active Comparator
Arm Description
Female subjects undergoing IVF/ET treated with 60 mg progesterone intramuscularly once daily
Intervention Type
Drug
Intervention Name(s)
Micronised Progesterone
Other Intervention Name(s)
Crinone 8%
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
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.
Primary Outcome Measure Information:
Title
The difference in hCG positive rate in the two arms 14 days after embryo transfer
Title
The difference in pregnancy rates in the two arms 30 and 60 days after embryo transfer
Title
The difference in implantation rate in the two arms 30 days after embryo transfer
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huafei Li
Organizational Affiliation
Serono Pharmaceutical Limited
Official's Role
Study Director
Facility Information:
Facility Name
Peking University 3rd Hopistal
City
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)
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