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
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring GnRH antagonist, GnRH agonist, pregnancy rate, Ovarian stimulation
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
Sites / Locations
- Yazd Research and Clinical Center For InfertilityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
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
1
Arm Type
Experimental
Arm Description
GnRH antagonist "ganirelix" 0.25 mg fromm 6th ovarian stimulation
Arm Title
2
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
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
Email
dr_firouzabadi@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
shahnaz Ahmadi, MD
Phone
9173717981
Ext
+98
Email
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
Email
dr_firouzabadi@yahoo.com
First Name & Middle Initial & Last Name & Degree
shahnaz Ahmadi, MD
Phone
9173717981
Ext
+98
Email
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
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