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Completed

NCT Number: NCT01489852

Estrogen Pretreatment Prior to GnRH Antagonist Protocol

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Service de Medecine de la Reproduction, Hôpital Jean Verdier

Bondy, Île-de-France Region, 93140, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

17beta-estradiol

Drug

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 outcomes

  1. number of retrieved oocytes

    Time frame: at the ovarian puncture, 36 hours post HCG administration

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Gemer

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Dec 12, 2011
Registry last updated
Dec 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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