Estrogen Pretreatment Prior to GnRH Antagonist Protocol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr CEDRIN-DURNERIN Isabelle, Gemer
ClinicalTrials.gov Identifier:
NCT01489852
First received: November 28, 2011
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

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
Infertility
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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489852

Locations
France
Service de Medecine de la Reproduction, Hôpital Jean Verdier
Bondy, Ile de France, France, 93140
Sponsors and Collaborators
Gemer
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr CEDRIN-DURNERIN Isabelle, principal investigator, Gemer
ClinicalTrials.gov 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:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Estrogens
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 30, 2014