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Efficacy of Urinary Follicle-Stimulating Hormone (FSH) Among Poor Responders

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by German Hospital, Istanbul.
Recruitment status was:  Not yet recruiting
Sponsor:
Collaborator:
Bahceci Women Health Care Center
Information provided by:
German Hospital, Istanbul
ClinicalTrials.gov Identifier:
NCT00677573
First received: May 9, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose
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.

Condition Intervention
Infertility
Drug: Fostimon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Urinary Purified Follicle-Stimulating Hormone (FSH) and Rec-FSH Among Poor Responders Undergoing Ovarian Stimulation With GnRH Antagonist

Resource links provided by NLM:


Further study details as provided by German Hospital, Istanbul:

Primary Outcome Measures:
  • pregnancy rate per embryo transfer [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of oocytes retrieved [ Time Frame: per patient ] [ Designated as safety issue: No ]

Study Start Date: May 2008
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: UrFSH Drug: Fostimon
450 IU for 4 days then adjusted

  Eligibility

Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one trial with adequate ovarian stimulation resulted by 4 or less oocytes retrieval.

Exclusion Criteria:

  • High responder patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677573

Locations
Turkey
Alman Hastanesi
İstanbul, Turkey
Sponsors and Collaborators
German Hospital, Istanbul
Bahceci Women Health Care Center
  More Information

Responsible Party: German Hospital, Istanbul
ClinicalTrials.gov Identifier: NCT00677573     History of Changes
Other Study ID Numbers: ughno1 
Study First Received: May 9, 2008
Last Updated: May 9, 2008
Health Authority: Turkey: Ministry of Health

Keywords provided by German Hospital, Istanbul:
ART
poor responder
GnRH antagonist
Gonadotropins

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016