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Comparison of the Long GnRH Agonist Protocol and the Flexible GnRH Antagonist Protocol of Ovarian Stimulation

NCT ID: NCT00417183

Last Updated: 2006-12-29

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to compare the efficacy of two controlled ovarian stimulation protocols, the GnRH agonist protocol, widely known as the "long" protocol, and the flexible GnRH antagonist protocol, in terms of pregnancy rates and embryological data, in infertile patients receiving IVF treatment.

Detailed Description

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The formulation of controlled ovarian stimulation protocols is one of the primary reasons for the successful development of IVF. The "long" GnRH agonist protocol, also known as the gold standard, has been widely used with considerable success. More recently, on the other hand, GnRH antagonist provide a new promising approach for endogenous gonadotrophin suppression by blocking the GnRH receptor. There is conflicting data in the literature regarding the relative merits of the two ovarian stimulation protocols.

COMPARISON: Pregnancy rates and embryological data will by assessed in IVF patients treated with either the "long" GnRH agonist (Arvekap) or the flexible GnRH antagonist (Ganirelix) protocol.

Conditions

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Infertility

Keywords

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GnRH antagonist GnRH agonist Long protocol Flexible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Arvekap 0.1 mg (Triptorelin, Ipsen, France)

Intervention Type DRUG

Ganirelix 0.25 (Orgalutran, Organon, The Netherlands)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-39 years
* Body mass index 18-29 kg/m2
* Menstrual cycle from 24-35 days
* Normal basal FSH (\<10 IU/ml)
* Normal basal LH (\<10 IU/ml)
* Normal basal estradiol (\<80 pg/ml)

Exclusion Criteria

* Poor responder patients
* Polycystic ovaries
Minimum Eligible Age

21 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eugonia

OTHER

Sponsor Role lead

Principal Investigators

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Tryfon Lainas, PhD

Role: PRINCIPAL_INVESTIGATOR

Eugonia

Locations

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Eugonia

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Tryfon Lainas, PhD

Role: CONTACT

Phone: 00302107236333

Email: [email protected]

Facility Contacts

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Tryfon Lainas, PhD

Role: primary

References

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Lainas T, Zorzovilis J, Petsas G, Stavropoulou G, Cazlaris H, Daskalaki V, Lainas G, Alexopoulou E. In a flexible antagonist protocol, earlier, criteria-based initiation of GnRH antagonist is associated with increased pregnancy rates in IVF. Hum Reprod. 2005 Sep;20(9):2426-33. doi: 10.1093/humrep/dei106. Epub 2005 Jun 9.

Reference Type BACKGROUND
PMID: 15946995 (View on PubMed)

Other Identifiers

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long vs flexible

Identifier Type: -

Identifier Source: org_study_id