Fixed Versus Flexible Gonadotropin-releasing Hormone (GnRH) Antagonist Initiation

NCT ID: NCT01005784

Last Updated: 2009-11-02

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

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-03-31

Brief Summary

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This is a comparison of pregnancy achievement between two GnRH antagonist protocols which differ in the timing of GnRH antagonist initiation.

Detailed Description

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Conditions

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Subfertility

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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fixed

Group Type ACTIVE_COMPARATOR

Cetrorelix (Cetrotide)

Intervention Type DRUG

fixed antagonist administration on day 6 of ovarian stimulation

flexible

Group Type EXPERIMENTAL

Cetrorelix (Cetrotide)

Intervention Type DRUG

flexible antagonist administration according to specified criteria

Interventions

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Cetrorelix (Cetrotide)

flexible antagonist administration according to specified criteria

Intervention Type DRUG

Cetrorelix (Cetrotide)

fixed antagonist administration on day 6 of ovarian stimulation

Intervention Type DRUG

Other Intervention Names

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Cetrorelix, Cetrotide, Serono Cetrorelix, Cetrotide, Serono

Eligibility Criteria

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Inclusion Criteria

* \< 39 years of age
* BMI 18.5-29.9
* \<= 3 previous IVF cycles

Exclusion Criteria

* PCOS
* Endometriosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Medical School, Aristotle University of Thessaloniki

Principal Investigators

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Efstratios Kolibianakis

Role: PRINCIPAL_INVESTIGATOR

Unit for Human Reproduction

Locations

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Unit for Human Reproduction

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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Kolibianakis EM, Venetis CA, Kalogeropoulou L, Papanikolaou E, Tarlatzis BC. Fixed versus flexible gonadotropin-releasing hormone antagonist administration in in vitro fertilization: a randomized controlled trial. Fertil Steril. 2011 Feb;95(2):558-62. doi: 10.1016/j.fertnstert.2010.05.052. Epub 2010 Jul 16.

Reference Type DERIVED
PMID: 20637457 (View on PubMed)

Other Identifiers

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UHR-3

Identifier Type: -

Identifier Source: org_study_id

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