hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF
Influence of Ovarian Stimulation With hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF
1 other identifier
interventional
80
1 country
1
Brief Summary
There have been some controversies regarding the use of preparations with LH activity in patients with polycystic ovary syndrome (PCOS) who have high endogenous LH activity. In this research we aimed to compare urinary menotrophin versus recombinant FSH (rFSH) with respect to the prevention of OHSS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 31, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedMarch 29, 2012
March 1, 2012
5 months
May 31, 2011
March 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
the incidence of OHSS
6 Months
peak serum E2 levels
6 months
Secondary Outcomes (3)
the need of coasting,
6 months
number of intermediate follicles
6 months
fertilization rate
6 months
Study Arms (2)
menotrophin
ACTIVE COMPARATORIn this prospective trial, women with PCOS (according to Rotterdam criteria) were randomized (80 patients) after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.
recombinant FSH
ACTIVE COMPARATORPatients were randomized after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.
Interventions
In this prospective trial, women with PCOS (according to Rotterdam criteria) were randomized (80 patients) after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.
Patients were randomized after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.
Eligibility Criteria
You may qualify if:
- Women with PCOS
You may not qualify if:
- Patients older than 38 years or with serum FSH level ≥12mIU/ml and a history of ovarian surgery were excluded from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zekai Tahir Burak women's research and Training Hospital
Ankara, Turkey (Türkiye)
Related Publications (1)
Figen Turkcapar A, Seckin B, Onalan G, Ozdener T, Batioglu S. Human Menopausal Gonadotropin versus Recombinant FSH in Polycystic Ovary Syndrome Patients Undergoing In Vitro Fertilization. Int J Fertil Steril. 2013 Jan;6(4):238-43. Epub 2013 Mar 3.
PMID: 24520446DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Figen A Turkcapar, MD
Zekai Tahir Burak Women's Health Research and Training Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 31, 2011
First Posted
June 3, 2011
Study Start
January 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
March 29, 2012
Record last verified: 2012-03