Back to results

Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

Primary Purpose

Infertility

Status

Unknown status

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

ganirelix

suprefact

About this trial

This is an interventional treatment trial for Infertility focused on measuring GnRH antagonist, GnRH agonist, pregnancy rate, Ovarian stimulation

Eligibility Criteria

undefined - 35 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Yazd Research and Clinical Center For InfertilityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

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

GnRH agonist, suprefact, stimulation with a standard long protocol

Outcomes

Primary Outcome Measures

pregnancy rate

Secondary Outcome Measures

ovarian stimulation

Full Information

NCT ID

NCT00823602

First Posted

January 13, 2009

Last Updated

January 14, 2009

Sponsor

Yazd Research & Clinical Center for Infertility

1. Study Identification

Unique Protocol Identification Number

NCT00823602

Brief Title

Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

Official Title

Comparison Between GnRH Agonist Long Protocol And GnRH Antagonist Protocol In Outcome Of The First Cycle ART

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Unknown status

Study Start Date

March 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

January 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Yazd Research & Clinical Center for Infertility

4. Oversight

5. Study Description

Brief Summary

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

GnRH antagonist, GnRH agonist, pregnancy rate, Ovarian stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

GnRH agonist, suprefact, stimulation with a standard long protocol

Intervention Type

Drug

Intervention Name(s)

ganirelix

Intervention Description

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

Intervention Name(s)

suprefact

Intervention Description

GnRH agonist, standard protocol

Primary Outcome Measure Information:

Title

pregnancy rate

Time Frame

2weeks

Secondary Outcome Measure Information:

Title

ovarian stimulation

Time Frame

10days

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

razieh firouzabadi, MD

Phone

8247085

Ext

+98351

dr_firouzabadi@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

shahnaz Ahmadi, MD

Phone

9173717981

Ext

+98

AHMADISHAHNAZ2005@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

razieh firouzabadi, MD

Organizational Affiliation

Yazd Research & Clinical Center for Infertility

Official's Role

Study Chair

Facility Information:

Facility Name

Yazd Research and Clinical Center For Infertility

City

Yazd

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

razieh firouzabadi, MD

Phone

8247085

Ext

+98351

dr_firouzabadi@yahoo.com

First Name & Middle Initial & Last Name & Degree

shahnaz Ahmadi, MD

Phone

9173717981

Ext

+98

AHMADISHAHNAZ2005@yahoo.com

First Name & Middle Initial & Last Name & Degree

shahnaz ahmadi, MD

12. IPD Sharing Statement

Learn more about this trial

Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

We'll reach out to this number within 24 hrs