Estrogen Pretreatment Prior to GnRH Antagonist Protocol

NCT ID: NCT01489852

Last Updated: 2011-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

472 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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Conditions

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Infertility

Keywords

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Assisted reproductive treatment GnRH antagonist Estrogen pre-treatment Ovarian stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Estrogen pre-treatment

Group Type ACTIVE_COMPARATOR

17beta-estradiol

Intervention Type 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.

Control

The control group did not receive any pre-treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gemer

OTHER

Sponsor Role lead

Responsible Party

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Dr CEDRIN-DURNERIN Isabelle

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean Noel Hugues, MD, PhD

Role: STUDY_DIRECTOR

Hôpital Jean Verdier

Isabelle cedrin-durnerin, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Jean Verdier

Locations

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Service de Medecine de la Reproduction, Hôpital Jean Verdier

Bondy, Île-de-France Region, France

Site Status

Countries

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France

References

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Cedrin-Durnerin I, Guivarc'h-Leveque A, Hugues JN; Groupe d'Etude en Medecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.

Reference Type DERIVED
PMID: 22464760 (View on PubMed)

Other Identifiers

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E2PRETREATMENT

Identifier Type: -

Identifier Source: org_study_id