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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02397551
• Collaborator: Nile Ivf Center, Cairo, Egypt (Other), Adam International Hospital (Other)
• Enrollment: 200
• Locations: 3
• Arms: 2
• Actual Duration (Months): 34.1
• Patients Per Site: 66.7
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Procedure: IVF/ICSI; Drug: Human Chorionic Gonadotropin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical pregnancy rate [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

Secondary Outcome Measures

1. OHSS rate [1 year]

   The number of cycles with evidence of OHSS

Other Outcome Measures

1. Chemical pregnancy rate [1 year]

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

2. Early miscarriage rate [1 year]

   Pregnancies that end up with miscarriage before 12 weeks gestation

3. Ongoing pregnancy rate [1 year]

   Pregnancies ongoing beyond 12 weeks gestation

4. Live birth rate [1 year]

   Pregnancies resulting in a live birth

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 37 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)	Cairo		Egypt
2	Adam International hospital	Giza		Egypt
3	Nile IVF center	Giza		Egypt

Sponsors and Collaborators

• Cairo University
• Nile Ivf Center, Cairo, Egypt
• Adam International Hospital

Investigators

• Study Director: Sarwat Ahwany, MD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yasmin Ahmed Bassiouny, Dr, Cairo University
• ClinicalTrials.gov Identifier: NCT02397551
• Other Study ID Numbers: 22015
• First Posted: Mar 25, 2015
• Last Update Posted: Jan 29, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Infertility; Chorionic Gonadotropin

Study Results

No Results Posted as of Jan 29, 2018