The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors
1 other identifier
interventional
20
1 country
1
Brief Summary
This pilot study aims to address whether the prophylactic use of Cetrorelix Acetate after a long gonadotropin-releasing hormone (GnRH) agonist protocol post-hCG (human chorionic gonadotropin) administration can significantly reduce the incidence of OHSS in oocyte donors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2009
Typical duration for not_applicable
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
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 21, 2009
CompletedFirst Posted
Study publicly available on registry
March 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
March 27, 2013
CompletedMarch 27, 2013
March 1, 2013
2.6 years
March 21, 2009
December 27, 2012
March 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS
evaluate by ultrasound examination, physical examination and blood work the incidence of ovarian hyperstimulation syndrome in oocyte donors receiving a single injection of 3 mg Cetrotide Acetate.
4 weeks
Ovarian Volumes as a Predictor of OHSS Severity
ultrasound measurements of both ovaries
30 days
Study Arms (1)
Cetrotide acetate
EXPERIMENTALoocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
Interventions
cetrotide acetate is a GnRH antagonist. The dose is 3 mg once on the day of oocyte retrieval.
Eligibility Criteria
You may qualify if:
- Prospective donors with BMIs between 19 and 28,
- Those with normal FSH levels and good antral follicle counts between 19-28 years of age, AND
- Donors would have passed all the required testing as mandated by VCRM and the FDA.
You may not qualify if:
- Oocyte donors exceeding a BMI of \> 28,
- Those with any communicable diseases,
- Those with low antral follicle counts and small ovarian volumes,
- Those with elevated FSH levels,
- Those with positive sickle cell screen or cystic fibrosis screening,
- Smokers, OR
- Donors who are unable or unwilling to follow the research protocols.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Center for Reproductive Medicine
Reston, Virginia, 20190, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Only 20 donors were recruited because this was a pilot study to assess the benefit of Cetrotide acetate in oocyte donors in the prevention of ovarian hyperstimulation syndrome.
Results Point of Contact
- Title
- Dr Fady Sharara
- Organization
- Virginia Center for Reproductive Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Fady I Sharara, M.D
Virginia Center for Reproductive Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
March 21, 2009
First Posted
March 24, 2009
Study Start
March 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
March 27, 2013
Results First Posted
March 27, 2013
Record last verified: 2013-03