Three Small Doses of HCG Versus Booster Dose of HCG on Ovum Pickup Day

NCT ID: NCT02397551

Last Updated: 2018-01-29

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-01-31

Brief Summary

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To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles triggered with GnRH agonist. Two strategies are compared supplementing the luteal phase with three small doses (500 IU) of HCG and giving a booster dose of HCG (1500 IU) on the day of ovum pickup.

Detailed Description

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Conditions

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Infertility

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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Small doses of HCG

Supplementing the luteal phase with three small doses (500 IU) of HCG after trigger with GnRH agonist in antagonist IVF/ICSI cycles in high responders

Group Type ACTIVE_COMPARATOR

IVF/ICSI

Intervention Type PROCEDURE

Human Chorionic Gonadotropin

Intervention Type DRUG

Given in different doses and timing to support the luteal phase

Booster HCG dose

Booster HCG dose GnRH agonist only to trigger final maturation followed by a booster dose of 1500 IU of HCG on the day of ovum pickup

Group Type ACTIVE_COMPARATOR

IVF/ICSI

Intervention Type PROCEDURE

Human Chorionic Gonadotropin

Intervention Type DRUG

Given in different doses and timing to support the luteal phase

Interventions

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IVF/ICSI

Intervention Type PROCEDURE

Human Chorionic Gonadotropin

Given in different doses and timing to support the luteal phase

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* High responder females undergoing antagonist protocol IVF/ICSI cycle
* More than 14 MII oocytes
* Estradiol more than 3500 pg/ml on day of trigger

Exclusion Criteria

* Any other protocol
* Normal or poor responders
Minimum Eligible Age

20 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nile Ivf Center, Cairo, Egypt

OTHER

Sponsor Role collaborator

Adam International Hospital

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yasmin Ahmed Bassiouny

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarwat Ahwany, MD

Role: STUDY_DIRECTOR

Cairo University

Locations

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IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)

Cairo, , Egypt

Site Status

Adam International hospital

Giza, , Egypt

Site Status

Nile IVF center

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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22015

Identifier Type: -

Identifier Source: org_study_id

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