Letrozole and Cabergoline Versus Letrozole Alone in Ovulation Induction

NCT ID: NCT07168837

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2024-05-10

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.

Detailed Description

In women with PCOS, the serum FSH levels are slightly lower during the follicular phase, therefore aromatization of excessive androgens is insufficient, and the follicles will not undergo the final FSH-dependent maturation in a dominant follicle. Furthermore, the serum level of anti-Mullerian hormone (AMH) is elevated. AMH counteracts the FSH-driven aromatase complex activity, so high AMH levels will inhibit granulosa cell conversion of androgens to estrogens and have a detrimental effect on final follicular maturation.

Previous studies showed that 30% of patients with PCOS show a modest rise in prolactin level. Increasing serum prolactin in these patients could be detected in both follicular and luteal phase of the normal and stimulated cycles. Dopamine release from the hypothalamus inhibits prolactin secretion, and it also affects the secretion of gonadotropins. When this inhibitory effect of dopamine is reduced, prolactin secretion will increase in addition to abnormalities in gonadotropins including luteinizing hormones.

Cabergoline which is a dopamine receptor agonist, with higher affinity to dopamine D2 receptors had improved uterine perfusion and achieved a better ovulatory response in PCOS patients, due to its ability to inhibit the vascular endothelial growth factor (VEGF) secretion in luteinized granulosa cells. Other studies concluded that Cabergoline use could normalize androgen level and therefore improve the menstrual irregularity in women with PCOS.

Letrozole is a third-generation aromatase inhibitor. It blocks the conversion of C-19 androgens to C-18 estrogens by competitively inhibiting the enzyme, aromatase (cytochrome P-450), which is an essential step in estrogen biosynthesis in the ovary and other tissues.The subsequent feedback to the hypothalamus containing reduced estrogen levels, triggers a compensatory increase in hypothalamic gonadotropin-releasing hormone (GnRH) secretion, and thus an increased release of pituitary gonadotropins FSH & LH. These gonadotropins subsequently promote growth of the follicles and stimulate ovulation. Letrozole has 99.9% bioavailability after oral administration. It has a single dose terminal half-life of 42 hours.

Conditions

PCOS (Polycystic Ovary Syndrome)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A (Letrozole with cabergoline)

About 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 Type: ACTIVE_COMPARATOR

Letrozole tablets

Intervention Type: DRUG

to compare between Letrozole withncabergoline and letrozole alone in ovulation induction among PCOS female patients.

Group B (Letrozole only)

About 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.

Group Type: ACTIVE_COMPARATOR

Letrozole tablets

Intervention Type: DRUG

to compare between Letrozole withncabergoline and letrozole alone in ovulation induction among PCOS female patients.

Interventions

Letrozole tablets

to compare between Letrozole withncabergoline and letrozole alone in ovulation induction among PCOS female patients.

Intervention Type: DRUG

Other Intervention Names

Cabergoline

Eligibility Criteria

Inclusion Criteria

• Women diagnosed with PCOS according to Rotterdam criteria (Rotterdam, 2004) as:

1. Menstrual anomalies like amenorrhea (no cycles in the past 6 months), oligomenorrhoea (cycles lasting longer than 35 days), or long cycles.

2. Clinical and/or biochemical hyperandrogenism.

3. Ultrasound (USG) appearance of polycystic ovaries (multiple cysts >12 in number of 2-9 mm size).

Exclusion Criteria

• Patient with liver and kidney disease.
• Congenital adrenal hyperplasia.
• Hypothalamic or pituitary cause of amenorrhea.
• Primary hyperprolactinemia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Esraa Hamouda Mohammed Ramadan

Resident of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

El-Kotb Hasan El-Kotb El-Saeidy, Professor

Role: STUDY_CHAIR

Obstetrics and Gynecology Department, Faculty of medicine,Al-Azhar University, Assiut.

Locations

Al-Azhar University Hospitals

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Letrozole and Cabergoline

Identifier Type: -

Identifier Source: org_study_id