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Evaluation of Letrozole in prevention of ovarian hyper stimulation syndrome

Evaluation of luteal phase Letrozole in GnRH antagonist protocol versus placebo administration to prevent ovarian hyper stimulation syndrome in PCOS, a randomized double blinded clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220522054961N2
Enrollment
128
Registered
2026-05-03
Start date
2026-05-02
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian hyper stimulation syndrome. Female infertility associated with anovulation

Interventions

Intervention 1: Intervention group: Letrozole 2.5 mg tablet, one every 12 hours from the day of ovulation for 5 days orally, prepared from Abu Raihan Pharmaceutical Company. Intervention 2: Control gr

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 40 Years

Inclusion criteria

Inclusion criteria: Young patients between the ages of 25 and 40 suffer from infertility. Their BMI is between 18 and 35 KG/M2. They have been diagnosed with PCOS according to the Rotterdam criteria. Have at least 15 dominant follicles on the day of trigger administration.

Exclusion criteria

Exclusion criteria: Have a serious medical disease. Have a history of allergy to letrozole. Patients with severe endometriosis. Patients who do not consent to participate in the study. Patients who do not cooperate with the study to return at specific times.

Design outcomes

Primary

MeasureTime frame
Ovarian hyper stimulation syndrome incidence rate. Timepoint: During the first 10 days after ovulation. Method of measurement: Based on the patient's symptoms and determining their severity with the RCOG green-top 2016 guidelines.;Serum estradiol levels. Timepoint: On the day of ovulation, 3 and 6 days after. Method of measurement: Patient's blood sample.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Najjari

Tehran University of Medical Sciences

zahra.z.najjari@gmail.com+98 21 7788 3285

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026