Estrogen Pretreatment Prior to GnRH Antagonist Protocol

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489852
• Other study ID #: E2PRETREATMENT
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2011
• Last updated: December 9, 2011
• Start date: December 2006
• Est. completion date: May 2011

Study information

• Verified date: December 2011
• Source: Gemer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 472
• Est. completion date: May 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• 17beta-estradiol
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.

Locations

Country	Name	City	State
France	Service de Medecine de la Reproduction, Hôpital Jean Verdier	Bondy	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Gemer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of retrieved oocytes		at the ovarian puncture, 36 hours post HCG administration	No
Secondary	pregnancy rate		at pregnancy test and at 6 Week US examination	No
Secondary	delivery rate		9 months later	No
Secondary	number of obtained embryos		2 days after in vitro fertilization	No
Secondary	duration of FSH administration	number of days of administration	at the end of ovarian stimulation usually after a mean of 12 days of administration	No
Secondary	Total FSH dose	daily dose x number of days of administration	at the end of ovarian stimulation usually after a mean of 12 days of administration	No