Agonist Gonadotropin-Releasing Hormone (GnRH) Versus Antagonist GnRH
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Yazd Research & Clinical Center for Infertility.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Yazd Research & Clinical Center for Infertility
Information provided by:
Yazd Research & Clinical Center for Infertility
ClinicalTrials.gov Identifier:
NCT00823602
First received: January 13, 2009
Last updated: January 14, 2009
Last verified: January 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: ganirelix Drug: suprefact |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison Between GnRH Agonist Long Protocol And GnRH Antagonist Protocol In Outcome Of The First Cycle ART |
Resource links provided by NLM:
MedlinePlus related topics:
Infertility
Drug Information available for:
Gonadorelin
Gonadorelin hydrochloride
Deslorelin
Ganirelix
Ganirelix acetate
U.S. FDA Resources
Further study details as provided by Yazd Research & Clinical Center for Infertility:
Primary Outcome Measures:
- pregnancy rate [ Time Frame: 2weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- ovarian stimulation [ Time Frame: 10days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 2 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | January 2009 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | up to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823602
Contacts
| Contact: razieh firouzabadi, MD | 8247085 ext +98351 | dr_firouzabadi@yahoo.com |
| Contact: shahnaz Ahmadi, MD | 9173717981 ext +98 | AHMADISHAHNAZ2005@yahoo.com |
Locations
| Iran, Islamic Republic of | |
| Yazd Research and Clinical Center For Infertility | Recruiting |
| Yazd, Iran, Islamic Republic of | |
| Contact: razieh firouzabadi, MD 8247085 ext +98351 dr_firouzabadi@yahoo.com | |
| Contact: shahnaz Ahmadi, MD 9173717981 ext +98 AHMADISHAHNAZ2005@yahoo.com | |
| Principal Investigator: shahnaz ahmadi, MD | |
Sponsors and Collaborators
Yazd Research & Clinical Center for Infertility
Investigators
| Study Chair: | razieh firouzabadi, MD | Yazd Research & Clinical Center for Infertility |
More Information
No publications provided
| Responsible Party: | Razieh Dehghani Firouzabadi, Yazd Research & Clinical Center for Infertility |
| ClinicalTrials.gov Identifier: | NCT00823602 History of Changes |
| Other Study ID Numbers: | 1387YAZDRCCI |
| Study First Received: | January 13, 2009 |
| Last Updated: | January 14, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yazd Research & Clinical Center for Infertility:
|
GnRH antagonist GnRH agonist pregnancy rate Ovarian stimulation |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Buserelin Ganirelix Deslorelin Fertility Agents, Female Fertility Agents |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013