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

Primary Purpose

Infertility

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

IVF/ICSI

Human Chorionic Gonadotropin

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
Adam International hospital
Nile IVF center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Small doses of HCG

Booster HCG dose

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

The number of cycles with a positive pregnancy test and evidence of a gestational sac with fetal pulsations after 5weeks from pregnancy test

Secondary Outcome Measures

OHSS rate

The number of cycles with evidence of OHSS

Full Information

NCT ID

NCT02397551

First Posted

March 16, 2015

Last Updated

January 25, 2018

Sponsor

Cairo University

Collaborators

Nile Ivf Center, Cairo, Egypt, Adam International Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02397551

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

March 2015 (Actual)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

Collaborators

Nile Ivf Center, Cairo, Egypt, Adam International Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Small doses of HCG

Arm Type

Active Comparator

Arm Description

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

Arm Title

Booster HCG dose

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

IVF/ICSI

Intervention Type

Drug

Intervention Name(s)

Human Chorionic Gonadotropin

Intervention Description

Given in different doses and timing to support the luteal phase

Primary Outcome Measure Information:

Title

Clinical pregnancy rate

Description

The number of cycles with a positive pregnancy test and evidence of a gestational sac with fetal pulsations after 5weeks from pregnancy test

Time Frame

1 year

Secondary Outcome Measure Information:

Title

OHSS rate

Description

The number of cycles with evidence of OHSS

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Chemical pregnancy rate

Description

The number of cycles with a positive pregnancy test after 14 days from embryo transfer

Time Frame

1 year

Title

Early miscarriage rate

Description

Pregnancies that end up with miscarriage before 12 weeks gestation

Time Frame

1 year

Title

Ongoing pregnancy rate

Description

Pregnancies ongoing beyond 12 weeks gestation

Time Frame

1 year

Title

Live birth rate

Description

Pregnancies resulting in a live birth

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

37 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarwat Ahwany, MD

Organizational Affiliation

Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Cairo

Country

Egypt

Facility Name

Adam International hospital

City

Giza

Country

Egypt

Facility Name

Nile IVF center

City

Giza

Country

Egypt

12. IPD Sharing Statement

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

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