Estrogen Pretreatment Prior to GnRH Antagonist Protocol

This study has been completed.
Information provided by (Responsible Party):
Dr CEDRIN-DURNERIN Isabelle, Gemer Identifier:
First received: November 28, 2011
Last updated: December 9, 2011
Last verified: December 2011

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

Condition Intervention Phase
Drug: 17beta-estradiol
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Gemer:

Primary Outcome Measures:
  • number of retrieved oocytes [ Time Frame: at the ovarian puncture, 36 hours post HCG administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pregnancy rate [ Time Frame: at pregnancy test and at 6 Week US examination ] [ Designated as safety issue: No ]
  • delivery rate [ Time Frame: 9 months later ] [ Designated as safety issue: No ]
  • number of obtained embryos [ Time Frame: 2 days after in vitro fertilization ] [ Designated as safety issue: No ]
  • duration of FSH administration [ Time Frame: at the end of ovarian stimulation usually after a mean of 12 days of administration ] [ Designated as safety issue: No ]
    number of days of administration

  • Total FSH dose [ Time Frame: at the end of ovarian stimulation usually after a mean of 12 days of administration ] [ Designated as safety issue: No ]
    daily dose x number of days of administration

Enrollment: 472
Study Start Date: December 2006
Study Completion Date: May 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Estrogen pre-treatment 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.
No Intervention: Control
The control group did not receive any pre-treatment.


Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01489852

Service de Medecine de la Reproduction, Hôpital Jean Verdier
Bondy, Ile de France, France, 93140
Sponsors and Collaborators
Study Director: Jean Noel Hugues, MD, PhD Hôpital Jean Verdier
Principal Investigator: Isabelle cedrin-durnerin, MD Hôpital Jean Verdier
  More Information

No publications provided by Gemer

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr CEDRIN-DURNERIN Isabelle, principal investigator, Gemer Identifier: NCT01489852     History of Changes
Other Study ID Numbers: E2PRETREATMENT
Study First Received: November 28, 2011
Last Updated: December 9, 2011
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Gemer:
Assisted reproductive treatment
GnRH antagonist
Estrogen pre-treatment
Ovarian stimulation

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Polyestradiol phosphate
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female processed this record on April 17, 2014