Estrogen Pretreatment Prior to GnRH Antagonist Protocol

NCT01489852 | Completed Phase 4

• 1 other identifier: E2PRETREATMENT
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Assisted reproductive treatment; GnRH antagonist; Estrogen pre-treatment; Ovarian stimulation

Outcome Measures

Primary Outcomes (1)

• number of retrieved oocytes

  at the ovarian puncture, 36 hours post HCG administration

Secondary Outcomes (5)

• pregnancy rate

  at pregnancy test and at 6 Week US examination

• delivery rate

  9 months later

• number of obtained embryos

  2 days after in vitro fertilization

• duration of FSH administration

  at the end of ovarian stimulation usually after a mean of 12 days of administration

• Total FSH dose

  at the end of ovarian stimulation usually after a mean of 12 days of administration

Study Arms (2)

Estrogen pre-treatment

ACTIVE COMPARATOR

Drug: 17beta-estradiol

Control

NO INTERVENTION

The control group did not receive any pre-treatment.

Interventions

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.

Estrogen pre-treatment

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gemer: lead

Study Sites (1)

Service de Medecine de la Reproduction, Hôpital Jean Verdier

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

Location

Related Publications (1)

• 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.

  PMID: 22464760 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jean Noel Hugues, MD, PhD

  Hôpital Jean Verdier

  STUDY DIRECTOR

• Isabelle cedrin-durnerin, MD

  Hôpital Jean Verdier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 12, 2011
• Study Start: December 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: May 1, 2011
• Last Updated: December 12, 2011

Record last verified: 2011-12

Locations

FR (1)