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

NCT ID: NCT02862782

Last Updated: 2016-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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In-vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hCG

Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono)

Group Type EXPERIMENTAL

hCG (Ovitrelle 250 mcg mcg - Merck Serono)

Intervention Type DRUG

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)

Group Type EXPERIMENTAL

hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh)

Intervention Type DRUG

Interventions

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hCG (Ovitrelle 250 mcg mcg - Merck Serono)

Intervention Type DRUG

hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Women with Ovarian Hyperstimulation Syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beni Almog, professor

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Central Contacts

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Beni Almog, professor

Role: CONTACT

052-4266991

Other Identifiers

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0317-16-TLV

Identifier Type: -

Identifier Source: org_study_id

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