Phase 4 N=71 Randomized Quadruple-blind Treatment

Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS

Ovarian Hyperstimulation Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01815138 ↗

Enrolled (actual)

Serious AEs

3.5%

Results posted

Sep 2017

Primary outcome: Primary: Ongoing Pregnancy — 15; 19 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: hCG (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: UConn Health
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Ongoing Pregnancy	15; 19	—
SECONDARY Ovarian Hyperstimulation Syndrome	1; 3	<0.05 sig

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 receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant hCG 1,500 IU 35 hours after GnRH agonist trigger.

Eligibility Criteria

Inclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01815138). 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.