Clinical Trial: The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome in Oocyte Donors

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.

Detailed Summary:

With varying complications, OHSS is an iatrogenic condition cause by ovarian stimulation. Classified as mild, moderate, or severe, mild OHSS is relatively common as it occurs in up to 1/3 of women undergoing ovarian stimulation. Symptoms include abdominal ascites, nausea, vomiting, increased abdominal girth and weight gain, with increasing ranges for mild to moderate. Severe OHSS occurs in 1% and includes hemodynamic instability, thrombosis, pulmonary difficulties, oliguria, and rarely death. Therefore, strategies to prevent or severely decrease the incidence of OHSS are sorely needed.

More aggressive ovarian stimulation increases the risk of OHSS, but it is not easy to predict who or who will not develop OHSS. Certain patient types, however, are considered to be at a higher risk than others, including oocyte donors. OHSS in oocyte donors manifests early, i.e. within days of oocyte retrieval, yet does not have the continued complication of pregnancy as observed in IVF patients. Therefore, as a in this vulnerable patient population, oocyte donors are ideal to study.

GnRH antagonists been most recently used in high risk patients undergoing IVF. Aside the reduction of OHSS observed after the traditional utilization of the antagonist protocol, alternative uses have also suggested favorable outcomes. Two retrospective, cohort matched studies evaluated a Ganirelix Acetate substitution in women who were at high risk for developing OHSS (E2 > 2,000 pg/ml on cycle day 6 or a projected peak E2 > 5,000 pg/ml with > 25 follicles on the day of HCG administration) after being down-regulated using GnRHa (or using a microdose flare protocol) and undergoing ovarian stimulation The GnRHa was stopped and only a low dose of hMG was continued when Ganirelix Acetate was started. The Ganirelix Acetate use resulted in an average drop of
Sponsor: Virginia Center for Reproductive Medicine

Current Primary Outcome:

• Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS [ Time Frame: 4 weeks ]
  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.
• Ovarian Volumes as a Predictor of OHSS Severity [ Time Frame: 30 days ]
  ultrasound measurements of both ovaries

Original Primary Outcome: OHSS incidence [ Time Frame: 4 weeks ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Virginia Center for Reproductive Medicine

Dates:
Date Received: March 21, 2009
Date Started: March 2009
Date Completion:
Last Updated: March 26, 2013
Last Verified: March 2013