Status:
COMPLETED
Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS
Lead Sponsor:
UConn Health
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Ovarian Hyperstimulation Syndrome
Eligibility:
FEMALE
18-39 years
Phase:
PHASE4
Brief Summary
This a prospective randomized double blind study involving patients at high risk of OHSS development with peak serum E2 levels \< 4,000 pg/ml comparing the ongoing pregnancy rates in patients who rece...
Detailed Description
Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation which may result in significant morbidity and rarely mortality as well as significant fina...
Eligibility Criteria
Inclusion
- Normal baseline serum follicle stimulating hormone, polycystic ovarian syndrome (PCOS), Polycystic ovarian morphology, Previous high responder or previous OHSS, must have \> 14 follicles of over 11 mm in diameter and with peak serum E2 levels \< 4,000 pg/mL on the day of trigger of oocyte maturation.
Exclusion
- Hypothalamic dysfunction, Patients with \< 14 follicles \< 11 mm in diameter, peak serum E2 levels \>= 4,000 pg/mL.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01815138
Start Date
March 1 2013
End Date
October 1 2016
Last Update
October 26 2018
Active Locations (1)
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1
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030