Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures

May 20, 2015 updated by: Shahar Kol MD, Rambam Health Care Campus

Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given.

The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

3

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

      • Haifa, Israel, 31096
        • IVF Unit, Rambam medical 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

35 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • IVF patients with at least 4 consecutive failures.
  • On trigger day, no more than 10 follicles of 12 mm and up

Exclusion Criteria:

  • History of moderate or severe OHSS.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: hCG trigger
Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
Other Names:
  • Ovulation trigger with Ovitrelle 250 microgram.
  • Luteal support with daily progesterone gel = Crinone 8%
Experimental: GnRH agonist trigger
ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
Other Names:
  • Oovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal Heart Activity 1 Month After Oocyte Retrieval
Time Frame: 1 month after oocyte retrieval
Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval
1 month after oocyte retrieval

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients Comfort During the Luteal Phase
Time Frame: During 2 weeks from day of oocyte retrieval
During 2 weeks from day of oocyte retrieval

Collaborators and Investigators

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

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

October 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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