Back to resultsEfficacy of Urinary Follicle-Stimulating Hormone (FSH) Among Poor Responders
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fostimon
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring ART, poor responder, GnRH antagonist, Gonadotropins
Eligibility Criteria
Inclusion Criteria:
- At least one trial with adequate ovarian stimulation resulted by 4 or less oocytes retrieval.
Exclusion Criteria:
- High responder patients
Sites / Locations
- Alman Hastanesi
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
UrFSH
Arm Description
Outcomes
Primary Outcome Measures
pregnancy rate per embryo transfer
Secondary Outcome Measures
number of oocytes retrieved
Full Information
NCT ID
NCT00677573
First Posted
May 9, 2008
Last Updated
May 9, 2008
Sponsor
German Hospital, Istanbul
Collaborators
Bahceci Women Health Care Center
1. Study Identification
Unique Protocol Identification Number
NCT00677573
Brief Title
Efficacy of Urinary Follicle-Stimulating Hormone (FSH) Among Poor Responders
Official Title
Comparison of Urinary Purified Follicle-Stimulating Hormone (FSH) and Rec-FSH Among Poor Responders Undergoing Ovarian Stimulation With GnRH Antagonist
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2008 (Anticipated)
Study Completion Date
November 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
German Hospital, Istanbul
Collaborators
Bahceci Women Health Care Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We proposed to compare outcomes in women with DOR undergoing ART with rec-FSH + u-HMH with those with u-FSH only in GnRH antagonist protocols.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ART, poor responder, GnRH antagonist, Gonadotropins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
UrFSH
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fostimon
Intervention Description
450 IU for 4 days then adjusted
Primary Outcome Measure Information:
Title
pregnancy rate per embryo transfer
Time Frame
6 months
Secondary Outcome Measure Information:
Title
number of oocytes retrieved
Time Frame
per patient
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least one trial with adequate ovarian stimulation resulted by 4 or less oocytes retrieval.
Exclusion Criteria:
High responder patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulun Ulug, M.D.
Phone
90-21-2293-2150
Ext
14111
Email
ulunulug@superonline.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Bahceci, M.D
Phone
90-21-2230-0809
Email
mbahceci@superonline.com
Facility Information:
Facility Name
Alman Hastanesi
City
İstanbul
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haluk Toygarlı, M.D.
Phone
90-21-2293-2150
First Name & Middle Initial & Last Name & Degree
ulun ulug, M.D.
First Name & Middle Initial & Last Name & Degree
mustafa bahceci, M.D.
First Name & Middle Initial & Last Name & Degree
enver kurt, M.D.
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Urinary Follicle-Stimulating Hormone (FSH) Among Poor Responders
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