Combination of Gonadotropin-releasing Hormone Agonist and Human Chorionic Gonadotropin Triggered by Normal Responder in GnRH-antagonist Cycles

August 10, 2016 updated by: Tel-Aviv Sourasky Medical Center

Background

The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment.

In a recently published work which compared two types of ovulation induction (standard dose of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a statistically significant increase in the rates of implantation, clinical pregnancies and live births rates by providing integration of hCG and GnRH agonist.

To conclude, providing GnRH agonist in combination of hCF in standard dose is today an accepted treatment for final maturation of the ovums.

OBJECTIVE

The investigators objective is to investigate whether providing integrated treatment of Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and live births rates in women treated with GnRH Antagonist protocol.

The main objective is to compare between two existing treatments.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background

The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment.

In order to prevent Ovarian Hyperstimulation Syndrome in the treatment cycles with GnRH antagonist protocol, it is possible to make the final maturation of the ovums by providing GnRH agonist.

In a recently published work which compared two types of ovulation induction (standard dose of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a statistically significant increase in the rates of implantation, clinical pregnancies and live births rates by providing integration of hCG and GnRH agonist.

To conclude, providing GnRH agonist in combination of hCF in standard dose is today an accepted treatment for final maturation of the ovums.

OBJECTIVE

The investigators objective is to investigate whether providing integrated treatment of Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and live births rates in women treated with GnRH Antagonist protocol.

The main objective is to compare between two existing treatments.

PATIENTS & METHODS

Women treated through IVF by protocol Gnarl - Antagonist

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

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

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who are going through IVF by protocol GnRH - Antagonist

Exclusion Criteria:

  • Women with Ovarian Hyperstimulation Syndrome

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
Experimental: hCG
Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono)
Drug: hCG (Ovitrelle 250 mcg mcg - Merck Serono)
Experimental: hCG + GnRH agonist
Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) and GnRH agonist - Gonadotropin - releasing hormone (Decapeptyl 0.2mg - Ferring Gmgh)
Drug: hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancies rate
Time Frame: 1 month
Number of pregnancies per treatment Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) and GnRH agonist - Gonadotropin - releasing hormone (Decapeptyl 0.2mg - Ferring Gmgh) in comperesment to Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono)
1 month

Collaborators and Investigators

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

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Beni Almog, professor, Tel Aviv Medical Center

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

September 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0317-16-TLV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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