GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
Gonadotropin Releasing Hormone Agonist for Luteal Phase Support in Long Gonadotropin Releasing Hormone Agonist Protocol Cycles
1 other identifier
interventional
200
1 country
2
Brief Summary
Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI) following long GnRHa protocol
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2016
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedStudy Start
First participant enrolled
September 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 30, 2023
October 1, 2023
8.3 years
December 5, 2014
October 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
6 weeks after embryo transfer
Secondary Outcomes (2)
Implantation rate
6 weeks after embryo transfer
Miscarriage rate
12 weeks gestational age
Study Arms (2)
GnRHa group
ACTIVE COMPARATORLuteal phase SC administration of a single dose (0.2 mg) of GnRHa (Triptorelin)
Control group
NO INTERVENTIONNo GnRHa administration in luteal phase
Interventions
Luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval
Eligibility Criteria
You may qualify if:
- Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRHa.
You may not qualify if:
- Moderate or severe endometriosis.
- Hydrosalpinx.
- Uterine abnormalities.
- Myoma.
- Previous uterine surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fertility Care Unit (FCU) in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111, Egypt
Private fertility care centers
Al Mansurah, Dakahlia Governorate, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed S Abdelhafez, Dr
Mansoura University
Central Study Contacts
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
December 5, 2014
First Posted
December 9, 2014
Study Start
September 9, 2016
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
October 30, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share