Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

• Sponsor: Yazd Research & Clinical Center for Infertility (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00823602
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2
• Duration (Months): 10.1
• Patients Per Site Per Month: 0.2

Study Details

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 .

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: ganirelix; Drug: suprefact	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison Between GnRH Agonist Long Protocol And GnRH Antagonist Protocol In Outcome Of The First Cycle ART
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Anticipated Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 GnRH antagonist "ganirelix" 0.25 mg fromm 6th ovarian stimulation	Drug: 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 ).
Active Comparator: 2 GnRH agonist, suprefact, stimulation with a standard long protocol	Drug: suprefact; GnRH agonist, standard protocol

Outcome Measures

Primary Outcome Measures

1. pregnancy rate [2weeks]

Secondary Outcome Measures

1. ovarian stimulation [10days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yazd Research and Clinical Center For Infertility	Yazd		Iran, Islamic Republic of

Sponsors and Collaborators

• Yazd Research & Clinical Center for Infertility

Investigators

• Study Chair: razieh firouzabadi, MD, Yazd Research & Clinical Center for Infertility

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00823602
• Other Study ID Numbers: 1387YAZDRCCI
• First Posted: Jan 15, 2009
• Last Update Posted: Jan 15, 2009
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: GnRH antagonist; GnRH agonist; pregnancy rate; Ovarian stimulation
• Additional relevant MeSH terms: Infertility; Buserelin; Ganirelix

Study Results

No Results Posted as of Jan 15, 2009