Letrozole and Cabergoline Versus Letrozole Alone in Ovulation Induction
1 other identifier
interventional
100
1 country
1
Brief Summary
Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorders in women of reproductive age. According to the World Health Organization (WHO) estimation revealed over 116 million women (3.4%) are affected by PCOS worldwide. Owing to the intricacy of this condition, various sets of diagnostic criteria have been initiated for the confirmation of PCOS which are: National Institute of Health, Rotterdam's Criteria, Androgen Excess and PCOS society. The prevalence of PCOS is estimated at about 4 to 21 % when it is diagnosed according to the Rotterdam criteria accounting for 75% of cases with anovulatory infertility.
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 Jan 2023
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
January 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2024
CompletedFirst Submitted
Initial submission to the registry
September 4, 2025
CompletedFirst Posted
Study publicly available on registry
September 11, 2025
CompletedSeptember 11, 2025
January 1, 2023
1.3 years
September 4, 2025
September 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Identification of Ovulation
Detection of Ovulation among the women whom participated and took the drugs of the study by making Serial ultrasound monitoring started from day 10 of menstrual cycle.
One week from drug taking
Study Arms (2)
Group A (Letrozole with cabergoline)
ACTIVE COMPARATORAbout 50 of infertile female with PCOs whom received Letrozole, 5mg daily for 5 days, from day 3 of the cycle up to 7th day for 3 cycles in addition to cabergoline, 0.5 mg weekly for 12 weeks.
Group B (Letrozole only)
ACTIVE COMPARATORAbout 50 of infertile female with PCOs whom received Letrozole only, 5mg daily for 5 days, from day 3 of the cycle up to 7th day for 3 cycles.
Interventions
to compare between Letrozole withncabergoline and letrozole alone in ovulation induction among PCOS female patients.
Eligibility Criteria
You may qualify if:
- Women diagnosed with PCOS according to Rotterdam criteria (Rotterdam, 2004) as:
- Menstrual anomalies like amenorrhea (no cycles in the past 6 months), oligomenorrhoea (cycles lasting longer than 35 days), or long cycles.
- Clinical and/or biochemical hyperandrogenism.
- Ultrasound (USG) appearance of polycystic ovaries (multiple cysts \>12 in number of 2-9 mm size).
You may not qualify if:
- Patient with liver and kidney disease.
- Congenital adrenal hyperplasia.
- Hypothalamic or pituitary cause of amenorrhea.
- Primary hyperprolactinemia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al-Azhar University Hospitals
Asyut, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
El-Kotb Hasan El-Kotb El-Saeidy, Professor
Obstetrics and Gynecology Department, Faculty of medicine,Al-Azhar University, Assiut.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident of Obstetrics & Gynecology
Study Record Dates
First Submitted
September 4, 2025
First Posted
September 11, 2025
Study Start
January 10, 2023
Primary Completion
May 1, 2024
Study Completion
May 10, 2024
Last Updated
September 11, 2025
Record last verified: 2023-01