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

September 25, 2018 updated by: Lawrence Engmann, UConn Health

A Prospective Double-blind Randomized Trial Comparing Pregnancy Rates After Low Dose Human Chorionic Gonadotropin (hCG) at the Time of Gonadotropin Releasing Hormone (GnRH) Agonist Trigger or 35 Hours Later for the Prevention of OHSS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 financial and psychological distress. GnRH agonist trigger has been shown to be effective in OHSS prevention. However, the adoption of its use has not been widely accepted in view of concerns regarding potential impairment of implantation.

Intensive luteal phase supplementation with estrogen (E2) and progesterone (P) is important due to the strong evidence of abnormal luteal phase serum E2 and P profiles. However, it has been shown that optimal conception rates is not achieved for high risk patients with peak serum E2 < 4,000 pg/ml despite aggressive steroidal supplementation. It has been proposed that the use of adjuvant low dose hCG at the time of GnRH agonist trigger or 35 hours later will rescue some of the corpora lutea and help improve corpora lutea function and improve pregnancy rates.

The study will evaluate patients at high risk of OHSS development with peak serum E2 < 4,000 pg/mL to determine whether timing of low dose hCG administration affects ongoing pregnancy rates or risk of OHSS. Markers of corpus luteum function such as serum 17 hydroxy-progesterone and prorenin during the luteal phase and early pregnancy will help elucidate further the effect of adjuvant low dose hCG with GnRH agonist trigger on corpus luteum function.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 on the day of trigger of oocyte maturation.

Exclusion Criteria:

  • Hypothalamic dysfunction, Patients with < 14 follicles < 11 mm in diameter, peak serum E2 levels >= 4,000 pg/mL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hCG given at time of GnRHa trigger

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

Placebo administered 35 hours after GnRH agonist trigger
Drug: hCG
Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger
Other Names:
  • Pregnyl, Profasi
Drug: hCG
Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger
Other Names:
  • Pregnyl, Profasi
Active Comparator: hCG given 35 hours after GnRHa trigger

Placebo administered at the time of GnRH agonist trigger

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.
Drug: hCG
Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger
Other Names:
  • Pregnyl, Profasi
Drug: hCG
Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger
Other Names:
  • Pregnyl, Profasi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing Pregnancy
Time Frame: Through time of study completion, on average 1-2years
Positive serum pregnancy test and ultrasound evidence of fetal pole and fetal heart rate .
Through time of study completion, on average 1-2years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian Hyperstimulation Syndrome
Time Frame: Within 4 weeks of oocyte retrieval
Evaluation of symptoms and signs of OHSS at 9 days after trigger of oocyte maturation. Patients who also present with symptoms of OHSS wil also be evaluated for OHSS within 4 weeks after oocyte maturation.
Within 4 weeks of oocyte retrieval

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Markers of Corpus Luteum Function
Time Frame: Within 60 days after trigger of oocyte maturation
A subset of patients (20 patients in each group) will have serum frozen for subsequent analysis of 17 hydroxy progesterone and prorenin.
Within 60 days after trigger of oocyte maturation
Proportion of Patients With Abdominal Distension
Time Frame: Within 2 weeks after trigger of oocyte maturation
Patients will complete a questionnaire to determine if there is a difference in the effect of the intervention on the quality of life (abdominal distension) of the patients from the day of trigger of oocyte maturation until menses or positive pregnancy test.
Within 2 weeks after trigger of oocyte maturation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Lawrence Engmann, MD, UConn Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 16, 2013

First Submitted That Met QC Criteria

March 18, 2013

First Posted (Estimate)

March 20, 2013

Study Record Updates

Last Update Posted (Actual)

October 26, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-098-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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