Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH

NCT00823602 | Unknown Phase 3

• 1 other identifier: 1387YAZDRCCI
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 .

Conditions

Infertility

Keywords

GnRH antagonist; GnRH agonist; pregnancy rate; Ovarian stimulation

Outcome Measures

Primary Outcomes (1)

• pregnancy rate

  2weeks

Secondary Outcomes (1)

• ovarian stimulation

  10days

Study Arms (2)

1

EXPERIMENTAL

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

Drug: ganirelix

2

ACTIVE COMPARATOR

GnRH agonist, suprefact, stimulation with a standard long protocol

Drug: suprefact

Interventions

ganirelix 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 ).

1

suprefact DRUG

GnRH agonist, standard protocol

2

Eligibility Criteria

• Age: Up to 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• previous IVF or ICSI, hyperprolactinemia, hyperthyroidism, hypothyroidism, uterine abnormality, severe endometriosis
• only one ovary

Sponsors & Collaborators

• Yazd Research & Clinical Center for Infertility: lead

Study Sites (1)

Yazd Research and Clinical Center For Infertility

Yazd, Yazd Province, Iran

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

ganirelix; Buserelin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• razieh firouzabadi, MD

  Yazd Research & Clinical Center for Infertility

  STUDY CHAIR

Central Study Contacts

razieh firouzabadi, MD

CONTACT

8247085; dr_firouzabadi@yahoo.com

shahnaz Ahmadi, MD

CONTACT

9173717981; AHMADISHAHNAZ2005@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 15, 2009
• Study Start: March 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: January 1, 2009
• Last Updated: January 15, 2009

Record last verified: 2009-01

Locations

IR (1)