Letrozole /GnRH Antagonist Protocol in Women Over 40 Years Undergoing ICSI Cycle
Impact of Adding Letrozole to Gonadotrophin-Releasing Hormone Antagonist Protocol in Women Over 40 Years Undergoing ICSI Cycle
1 other identifier
interventional
200
1 country
1
Brief Summary
The aim of this study To compare the clinical and laboratory outcomes of two ovarian stimulation protocols (standard GnRH antagonist protocol and aromatase inhibitor/ antagonist protocol) in women (40-44) years undergoing ICSI cycle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
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
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
December 8, 2021
CompletedFirst Posted
Study publicly available on registry
December 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2025
CompletedFebruary 12, 2025
February 1, 2025
3.3 years
December 8, 2021
February 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
live birth rate
deliveries ≥22 weeks gestation with heartbeat and breath
1 year after embryo transfer
Secondary Outcomes (7)
positive hCG
2 weeks after FET
clinical pregnancy
5 weeks' gestation
Total gonadotropin /cycle (IU),
two weeks
Duration of stimulation (Day),
two weeks
Endometrial thickness (mm)
two weeks
- +2 more secondary outcomes
Study Arms (2)
standard GnRH antagonist protocol
ACTIVE COMPARATORGonadotropins (300-450 IU) IM start on cycle day 2 then the dose modulated according to response
Aromatase inhibitor/flexible antagonist protocol
ACTIVE COMPARATORletrozole orally in a dose of 2.5 mg daily, on day 2 of cycle for 5 days and gonadotropins (300-450 IU) IM start on cycle day 3. then the dose modulated according to response
Interventions
letrozole (femara, Novartis) orally in a dose of 2.5 mg daily, on day 2 of cycle for 5 days and gonadotropins (300-450 IU) IM start on cycle day 3. then the dose modulated according to response
Eligibility Criteria
You may qualify if:
- Women between 40- 44-years undergoing ICSI cycle with FSH less than 15 and AMH more than 0.30.
You may not qualify if:
- Azoospermia in male partner,
- Previous ovarian surgery,
- Severe endometriosis,
- Uterine cavity lesion
- Metabolic or endocrine disorders including hyperprolactinemia and ypo/hyperthyroidism.
- Previous failed ICSI cycle.
- BMI more than 30.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Menoufia University hospital
Shibīn al Kawm, Menoufia, 11111, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of obstetrics and gynecology
Study Record Dates
First Submitted
December 8, 2021
First Posted
December 22, 2021
Study Start
November 1, 2021
Primary Completion
February 10, 2025
Study Completion
February 10, 2025
Last Updated
February 12, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share