N/A
N=20
The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors
Ovarian Hyperstimulation Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00867659 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS — 10 cc (volume of ascites)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cetrotide acetate (Drug)
- Age
- Adult · 19+ yrs
- Sex
- Female
- Sponsor
- Virginia Center for Reproductive Medicine
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS |
10 | — |
| PRIMARY Ovarian Volumes as a Predictor of OHSS Severity |
25 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00867659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.