Ovarian Hyperstimulation Syndrome Clinical Trial
Official title:
The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome in Oocyte Donors
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years to 32 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Virginia Center for Reproductive Medicine | Reston | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Center for Reproductive Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | Ovarian Volumes as a Predictor of OHSS Severity | ultrasound measurements of both ovaries | 30 days | No |
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