Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
ovarian stimulation
ovarian stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring IVF, ICSI, GnRH antagonist, pretreatment
Eligibility Criteria
Inclusion Criteria:
- < 39 years old on day of randomisation
- FSH < 12 (in the early follicular phase)
- Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
- Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
- BMI between 18 and 29 (both inclusive)
- 1st or 2nd trial
- IVF or ICSI
- Randomisation at out-patient clinic
Exclusion Criteria:
- ≥ 39 years old on day of randomisation
- Endometriosis ≥ grade 3
- PCOS
Sites / Locations
- UZ Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
A
B
Arm Description
Patients undergo a standard treatment with a classical GnRH antagonist protocol.
Before undergoing a standard protocol for ovarian stimulation, patients in this group receive a pretreatment with GnRH antagonists during 3 consecutive days
Outcomes
Primary Outcome Measures
Endocrine profile
The purpose is to assess the endocrine profile in each treatment group
Secondary Outcome Measures
Pregnancy rate
The purpose is to study the pregnancy rate in each treatment group
Full Information
NCT ID
NCT01093443
First Posted
March 24, 2010
Last Updated
October 8, 2010
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT01093443
Brief Title
Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days
Official Title
Administration of a GnRH Antagonist During 3 Days at Initiation of the Cycle: Impact on the Stimulation in IVF/ICSI
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this prospective study, the investigators would like to show whether ovarian stimulation with pretreatment of a GnRH antagonist during 3 consecutive days at initiation of the cycle, is possible.
Detailed Description
A recently accepted study demonstrated that raised progesterone levels can be normalized through administration of a GnRH antagonist during three subsequent days prior to the start of gonadotropin stimulation in a GnRH antagonist protocol. This regimen, after normalisation of the progesterone value, allows controlled ovarian hyperstimulation (COH). Since this regimen is valid in case of elevated progesterone, GnRH antagonists pretreatment may prove to be a valid tool for scheduling IVF treatment in patients with normal progesterone values on day 2 of the cycle. In this prospective randomised trial, the investigators study the impact of administration of a GnRH antagonist during 3 consecutive days at initiation of the cycle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, ICSI, GnRH antagonist, pretreatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Patients undergo a standard treatment with a classical GnRH antagonist protocol.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Before undergoing a standard protocol for ovarian stimulation, patients in this group receive a pretreatment with GnRH antagonists during 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
ovarian stimulation
Intervention Description
rFSH with GnRH antagonists
Intervention Type
Drug
Intervention Name(s)
ovarian stimulation
Intervention Description
GnRH antagonist, rFSH, GnRH antagonist
Primary Outcome Measure Information:
Title
Endocrine profile
Description
The purpose is to assess the endocrine profile in each treatment group
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
Pregnancy rate
Description
The purpose is to study the pregnancy rate in each treatment group
Time Frame
up to 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
< 39 years old on day of randomisation
FSH < 12 (in the early follicular phase)
Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
BMI between 18 and 29 (both inclusive)
1st or 2nd trial
IVF or ICSI
Randomisation at out-patient clinic
Exclusion Criteria:
≥ 39 years old on day of randomisation
Endometriosis ≥ grade 3
PCOS
Facility Information:
Facility Name
UZ Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
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Gonadotropin-releasing Hormone (GnRH) Antagonist During 3 Days
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