Back to resultsEstrogen Pretreatment Prior to GnRH Antagonist Protocol
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
17beta-estradiol
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Assisted reproductive treatment, GnRH antagonist, Estrogen pre-treatment, Ovarian stimulation
Eligibility Criteria
Inclusion Criteria:
- regular normo-ovulatory cycles (28 to 35 days)
- age < 38 years,
- body mass index (BMI) between 18 and 30
- first or second IVF/ICSI attempt
Exclusion Criteria:
- high basal levels of serum FSH or E2,
- less than 5 follicles at the antral follicular count performed on day 3 of a spontaneous cycle,
- history of high (>20 oocytes) or low (< 5 oocytes) ovarian response in a previous IVF attempt
Sites / Locations
- Service de Medecine de la Reproduction, Hôpital Jean Verdier
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Estrogen pre-treatment
Control
Arm Description
The control group did not receive any pre-treatment.
Outcomes
Primary Outcome Measures
number of retrieved oocytes
Secondary Outcome Measures
pregnancy rate
delivery rate
number of obtained embryos
duration of FSH administration
number of days of administration
Total FSH dose
daily dose x number of days of administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01489852
Brief Title
Estrogen Pretreatment Prior to GnRH Antagonist Protocol
Official Title
Interest of a Steroid Pre-treatment Prior to IVF Protocol With Ovarian Stimulation by Recombinant FSH and With LH Surge Blockage by Daily GnRH Antagonist
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gemer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Assisted reproductive treatment, GnRH antagonist, Estrogen pre-treatment, Ovarian stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
472 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Estrogen pre-treatment
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group did not receive any pre-treatment.
Intervention Type
Drug
Intervention Name(s)
17beta-estradiol
Intervention Description
Pretreatment with 17beta-estradiol (Provames®, Aventis, Paris, France) was administered daily (2 mg twice a day) during the cycle preceding the IVF/ICSI cycle, starting 7 days before the predicted onset of menses and administered up until to the following Thursday after the occurrence of menses.
Primary Outcome Measure Information:
Title
number of retrieved oocytes
Time Frame
at the ovarian puncture, 36 hours post HCG administration
Secondary Outcome Measure Information:
Title
pregnancy rate
Time Frame
at pregnancy test and at 6 Week US examination
Title
delivery rate
Time Frame
9 months later
Title
number of obtained embryos
Time Frame
2 days after in vitro fertilization
Title
duration of FSH administration
Description
number of days of administration
Time Frame
at the end of ovarian stimulation usually after a mean of 12 days of administration
Title
Total FSH dose
Description
daily dose x number of days of administration
Time Frame
at the end of ovarian stimulation usually after a mean of 12 days of administration
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
regular normo-ovulatory cycles (28 to 35 days)
age < 38 years,
body mass index (BMI) between 18 and 30
first or second IVF/ICSI attempt
Exclusion Criteria:
high basal levels of serum FSH or E2,
less than 5 follicles at the antral follicular count performed on day 3 of a spontaneous cycle,
history of high (>20 oocytes) or low (< 5 oocytes) ovarian response in a previous IVF attempt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Noel Hugues, MD, PhD
Organizational Affiliation
Hôpital Jean Verdier
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Isabelle cedrin-durnerin, MD
Organizational Affiliation
Hôpital Jean Verdier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Medecine de la Reproduction, Hôpital Jean Verdier
City
Bondy
State/Province
Ile de France
ZIP/Postal Code
93140
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22464760
Citation
Cedrin-Durnerin I, Guivarc'h-Leveque A, Hugues JN; Groupe d'Etude en Medecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.
Results Reference
derived
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Estrogen Pretreatment Prior to GnRH Antagonist Protocol
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