Three Small Doses of HCG Versus Booster Dose of HCG on Ovum Pickup Day
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
1 other identifier
interventional
200
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2015
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 16, 2015
CompletedFirst Posted
Study publicly available on registry
March 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJanuary 29, 2018
January 1, 2018
2.8 years
March 16, 2015
January 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (1)
OHSS rate
1 year
Other Outcomes (4)
Chemical pregnancy rate
1 year
Early miscarriage rate
1 year
Ongoing pregnancy rate
1 year
- +1 more other outcomes
Study Arms (2)
Small doses of HCG
ACTIVE COMPARATORSupplementing 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
ACTIVE COMPARATORBooster 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
Interventions
Given in different doses and timing to support the luteal phase
Eligibility Criteria
You may qualify if:
- High responder females undergoing antagonist protocol IVF/ICSI cycle
- More than 14 MII oocytes
- Estradiol more than 3500 pg/ml on day of trigger
You may not qualify if:
- Any other protocol
- Normal or poor responders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- Nile Ivf Center, Cairo, Egyptcollaborator
- Adam International Hospitalcollaborator
Study Sites (3)
IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
Cairo, Egypt
Adam International hospital
Giza, Egypt
Nile IVF center
Giza, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sarwat Ahwany, MD
Cairo University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
March 16, 2015
First Posted
March 25, 2015
Study Start
March 1, 2015
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
January 29, 2018
Record last verified: 2018-01