Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF

NCT ID: NCT01798836

Last Updated: 2015-08-06

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

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-02-28

Brief Summary

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To evaluate the effect of oestradiol pre-treatment in a combined ultrashort flare GnRH agonist /GnRH antagonist protocol

Detailed Description

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The combined ultrashort flare GnRH agonist /GnRH antagonist protocol during COH cycle resulted in a significantly higher clinical pregnancy rate in patients with poor embryo quality, with repeated IVF failures and in poor responders. This is a protocol combining the effect of the microdose flare on endogenous FSH release with the benefit of an immediate LH suppression of the GnRH antagonist.

A major disadvantage of the use of a GnRH antagonist protocol is the limitation for programming cycles, as the drugs administration is started on day 2 of the menstrual cycle and is strictly followed until the hCG criteria are met.

The purpose of the study is to perform oestradiol pre-treatment with the combined ultrashort flare GnRH agonist /GnRH antagonist protocol aiming to

1. better programme an antagonist cycle and
2. improve the IVF outcome parameters, from the production of more follicles / oocytes up to the rise in live birth rates.

Conditions

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Infertility

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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Oestradiol and ultrashort GnRH agonist/antagonist protocol

Women will begin pretreatment with 4 mg/day of 17 β-estradiol before the combination of GnRH ultashort agonist and antagonist protocol

Group Type EXPERIMENTAL

Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol

Intervention Type PROCEDURE

GnRH agonist or antagonist protocol.

Women will undergo either a conventional short or long GnRH agonist or an antagonist protocol during COH for IVF

Group Type ACTIVE_COMPARATOR

GnRH agonist or antagonist protocol without oestradiol pre-treatment

Intervention Type PROCEDURE

Interventions

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Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol

Intervention Type PROCEDURE

GnRH agonist or antagonist protocol without oestradiol pre-treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with poor or no response in previous COH for IVF cycles
* Patients with AMH \< 1 and/or FSH \>12
* Poor quality of embryos in previous cycles
* Age of patients up to 44 years

Exclusion Criteria

* Patients with normal ovarian reserve
* Patients with sonographically detected hydrosalpinges
* Presence of intramural fibroid distorting the endometrial cavity or submucous myoma or Asherman's syndrome
* Women with thrombofilia disorders
Minimum Eligible Age

25 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Siristatidis Charalampos, MD, PhD

Assistant Professor in Obstetrics and Gynecology/Assisted Reproduction

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George Salamalekis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

Charalampos Siristatidis, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

Locations

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Assisted Reproduction Unit, 3rd Department of Obstetrics and Gynecology. Attikon University Hospital

Athens, Attica, Greece

Site Status

Countries

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Greece

References

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Griesinger G, Kolibianakis EM, Venetis C, Diedrich K, Tarlatzis B. Oral contraceptive pretreatment significantly reduces ongoing pregnancy likelihood in gonadotropin-releasing hormone antagonist cycles: an updated meta-analysis. Fertil Steril. 2010 Nov;94(6):2382-4. doi: 10.1016/j.fertnstert.2010.04.025. Epub 2010 May 26.

Reference Type BACKGROUND
PMID: 20537631 (View on PubMed)

Bosch E. Can we skip weekends in GnRH antagonist cycles without compromising the final outcome? Fertil Steril. 2012 Jun;97(6):1299-300. doi: 10.1016/j.fertnstert.2012.04.024. No abstract available.

Reference Type BACKGROUND
PMID: 22656307 (View on PubMed)

Orvieto R, Nahum R, Rabinson J, Gemer O, Anteby EY, Meltcer S. Ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist for patients with repeated IVF failures and poor embryo quality. Fertil Steril. 2009 Apr;91(4 Suppl):1398-400. doi: 10.1016/j.fertnstert.2008.04.064. Epub 2008 Aug 3.

Reference Type RESULT
PMID: 18675974 (View on PubMed)

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 RESULT
PMID: 22464760 (View on PubMed)

Other Identifiers

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030675

Identifier Type: -

Identifier Source: org_study_id

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