NCT06861803Not yet recruiting
Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients
Comparison of Laboratory and Ultrasound Findings Between Letrozole-Resistant and Letrozole-Sensitive PCOS Patients in Egypt
Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational study is to compare laboratory and ultrasound findings between letrozole-resistant and letrozole-sensitive PCOS patients in Egypt. The study will include women aged 18-40 years diagnosed with PCOS based on the Rotterdam criteria, who are undergoing ovulation induction with letrozole for the first time. The main questions it aims to answer are: What are the baseline laboratory and ultrasound differences between letrozole-resistant and letrozole-sensitive PCOS patients? What factors can predict letrozole resistance in PCOS patients? Researchers will compare letrozole-resistant and letrozole-sensitive PCOS patients to determine whether specific laboratory markers and ultrasound findings can predict resistance to letrozole. Participants will: Undergo baseline clinical, laboratory, and ultrasound assessments before starting letrozole treatment. Receive letrozole treatment with dose escalation up to 7.5 mg/day over a maximum of three cycles if ovulation is not achieved. Be monitored through serial transvaginal ultrasounds to assess follicular development. Have ovulation confirmed via mid-luteal serum progesterone levels. The study aims to improve the understanding of predictors of letrozole resistance to guide personalized ovulation induction strategies in PCOS patients.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 138 (estimated)
- First submitted
- 18 Feb 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Al-Azhar University
- NCT number
- NCT06861803
What you commit to
- Study type: Observational
- Planned participants: 138
- From 1 Apr 2025 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ovarian surgery or use of medications that could influence ovulation.
Other illness
- Comorbidities such as uncontrolled diabetes, hyperprolactinemia, or thyroid dysfunction.
Other
- Infertility due to other causes such as tubal obstruction or male factor infertility.
Who the study is looking for
- Women aged 18-40 years.
- Diagnosis of PCOS based on Rotterdam criteria.
- No prior ovulation induction with letrozole.
- Willing to follow the treatment protocol and attend follow-up visits
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Al-Hussein University Hospital Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.