Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle
Comparison Between Agonist Trigger With HCG Luteal Phase Supplementation vs HCG Trigger With Progesterone Luteal Phase Supplementation in Antagonist Controlled HyperstimulationCycle Regarding Clinical Pregnancy Rate
1 other identifier
interventional
100
1 country
1
Brief Summary
The aim of the current study is to compare agonist trigger and HCG luteal support vs standard HCG trigger and progesterone luteal supplementation in antagonist controlled hyperstimulation cycle as regards to clinical pregnancy rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2021
CompletedNovember 18, 2021
November 1, 2021
3.1 years
December 31, 2016
November 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate
Clinical pregnancy diagnosed by pregnancy test and ultrasound
1 year
Study Arms (2)
Group 1
ACTIVE COMPARATORThey will receive a single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections
Group 2
ACTIVE COMPARATORThey will receive a single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).
Interventions
Eligibility Criteria
You may qualify if:
- Age between 20 and 39 years.
- Body mass index between 18 and 30.
- Unexplained infertility or male factor infertility
You may not qualify if:
- Endocrinological disorder eg.:hyperprolactenemia, Hypo or hyper thyrodism
- More than 2 previous attemptsof IVF
- Any uterine anatomical anomaly.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AinShams Maternity Hospital
Cairo, 002, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 31, 2016
First Posted
April 15, 2021
Study Start
December 1, 2016
Primary Completion
January 1, 2020
Study Completion
June 1, 2020
Last Updated
November 18, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share