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

NCT01815138 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2018-10-26

Study results available
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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.

Conditions

  • Ovarian Hyperstimulation Syndrome

Interventions

DRUG

hCG

Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger

DRUG

hCG

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger

Sponsors & Collaborators

Principal Investigators

  • Lawrence Engmann, MD · UConn Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-12-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01815138 on ClinicalTrials.gov