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

January 25, 2018 updated by: Yasmin Ahmed Bassiouny, Cairo University

Supplementing the Luteal Phase With Three Small Doses of HCG Versus Booster Dose of HCG on Ovum Pickup Day in Antagonist IVF/ICSI Cycles Triggered With GnRH Agonist in High Responder Females to Salvage the Luteal Phase

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

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

  • Egypt
      • Cairo, Egypt
        • IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
      • Giza, Egypt
        • Adam International Hospital
      • Giza, Egypt
        • Nile IVF 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

20 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: 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
Procedure: IVF/ICSI
Drug: Human Chorionic Gonadotropin
Given in different doses and timing to support the luteal phase
Active Comparator: 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
Procedure: IVF/ICSI
Drug: Human Chorionic Gonadotropin
Given in different doses and timing to support the luteal phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 1 year
The number of cycles with a positive pregnancy test and evidence of a gestational sac with fetal pulsations after 5weeks from pregnancy test
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OHSS rate
Time Frame: 1 year
The number of cycles with evidence of OHSS
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemical pregnancy rate
Time Frame: 1 year
The number of cycles with a positive pregnancy test after 14 days from embryo transfer
1 year
Early miscarriage rate
Time Frame: 1 year
Pregnancies that end up with miscarriage before 12 weeks gestation
1 year
Ongoing pregnancy rate
Time Frame: 1 year
Pregnancies ongoing beyond 12 weeks gestation
1 year
Live birth rate
Time Frame: 1 year
Pregnancies resulting in a live birth
1 year

Collaborators and Investigators

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

Sponsor

Cairo University

Collaborators

Adam International Hospital
Nile Ivf Center, Cairo, Egypt

Investigators

  • Study Director: Sarwat Ahwany, MD, Cairo University

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 (Actual)

March 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22015

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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