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Estrogen Pretreatment Prior to GnRH Antagonist Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01489852
Recruitment Status : Completed
First Posted : December 12, 2011
Last Update Posted : December 12, 2011
Information provided by (Responsible Party):
Dr CEDRIN-DURNERIN Isabelle, Gemer

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: 17beta-estradiol Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2006
Primary Completion Date : July 2010
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Estradiol
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. number of retrieved oocytes [ Time Frame: at the ovarian puncture, 36 hours post HCG administration ]

Secondary Outcome Measures :
  1. pregnancy rate [ Time Frame: at pregnancy test and at 6 Week US examination ]
  2. delivery rate [ Time Frame: 9 months later ]
  3. number of obtained embryos [ Time Frame: 2 days after in vitro fertilization ]
  4. duration of FSH administration [ Time Frame: at the end of ovarian stimulation usually after a mean of 12 days of administration ]
    number of days of administration

  5. Total FSH dose [ Time Frame: at the end of ovarian stimulation usually after a mean of 12 days of administration ]
    daily dose x number of days of administration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: December 12, 2011    Key Record Dates
Last Update Posted: December 12, 2011
Last Verified: December 2011

Keywords provided by Dr CEDRIN-DURNERIN Isabelle, Gemer:
Assisted reproductive treatment
GnRH antagonist
Estrogen pre-treatment
Ovarian stimulation

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female