Dual Trigger Versus Booster Dose of HCG

Dual Trigger 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 dual trigger with GnRH agonist plus 1000 IU of HCG or triggering with GnRH and giving a booster dose of HCG (1500 IU) on the day of ovum pickup.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: IVF/ICSI; Drug: Human Chorionic Gonadotropin

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dual trigger; GnRH agonist plus 1000 IU of HCG to trigger final maturation	Procedure: IVF/ICSI; Drug: Human Chorionic Gonadotropin; given in different doses and timing to support the luteal phase
Active Comparator: 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	The number of cycles with a evidence of a gestational sac with fetal pulstaions after 5 weeks from pregnancy test	1 year

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Adam International Hospital; Nile Ivf Center, Cairo, Egypt
• Investigators: Study Director: Sarwat Ahwany, MD, Cairo University

Study record dates

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: Infertility; Physiological Effects of Drugs; Reproductive Control Agents; Chorionic Gonadotropin
• Other Study ID Numbers: 12015