Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

NCT ID: NCT00823602

Last Updated: 2009-01-15

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

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-01-31

Brief Summary

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Literature suggests that GnRH antagonists are comparatively more often used in cycles which have an unfavorable prior prognosis, and this protocol is an ideal one for poor responder patients. Up to now, however not enough prospectives have been published to prove any beneficial effect of antagonists on the first cycle assisted reproductive technique.

This prospective study will do to evaluate the efficacy of gonadotropin releasing hormone antagonist in comparison with the standard long protocol in the first cycle of ART.

The investigators will randomize 160 patients undergoing ART for the first time . Group 1 (n=80) was stimulate with a standard long protocol and group 2 (n=80) stimulated with GnRH antagonist and then result of ART compare in two group .

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

GnRH antagonist "ganirelix" 0.25 mg fromm 6th ovarian stimulation

Group Type EXPERIMENTAL

ganirelix

Intervention Type DRUG

These patients started ovarian stimulation with 150 - 225 IU Gonal F on the second day of menstrual cycle with an S.C. injection once a day. Initiation of 0.25 mg Ganirelix took place on the 6th of the stimulation (fixed protocol) when HMG (Menogon, ferring, pharmacenticals , Germany ).

2

GnRH agonist, suprefact, stimulation with a standard long protocol

Group Type ACTIVE_COMPARATOR

suprefact

Intervention Type DRUG

GnRH agonist, standard protocol

Interventions

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ganirelix

These patients started ovarian stimulation with 150 - 225 IU Gonal F on the second day of menstrual cycle with an S.C. injection once a day. Initiation of 0.25 mg Ganirelix took place on the 6th of the stimulation (fixed protocol) when HMG (Menogon, ferring, pharmacenticals , Germany ).

Intervention Type DRUG

suprefact

GnRH agonist, standard protocol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* first cycle of ART
* age \< 35 years
* basal FSH \< 10 IU/L

Exclusion Criteria

* previous IVF or ICSI, hyperprolactinemia, hyperthyroidism, hypothyroidism, uterine abnormality, severe endometriosis
* only one ovary
Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yazd Research & Clinical Center for Infertility

OTHER

Sponsor Role lead

Responsible Party

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Yazd Research & Clinical Center for Infertility

Principal Investigators

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razieh firouzabadi, MD

Role: STUDY_CHAIR

Yazd Research & Clinical Center for Infertility

Locations

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Yazd Research and Clinical Center For Infertility

Yazd, Yazd Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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razieh firouzabadi, MD

Role: CONTACT

8247085 ext. +98351

shahnaz Ahmadi, MD

Role: CONTACT

9173717981 ext. +98

Facility Contacts

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razieh firouzabadi, MD

Role: primary

8247085 ext. +98351

shahnaz Ahmadi, MD

Role: backup

9173717981 ext. +98

Other Identifiers

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1387YAZDRCCI

Identifier Type: -

Identifier Source: org_study_id

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