PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesNCT06861803
Laboratory and Ultrasound Findings and Response to Letrozole in PCOS Patients
An observational study of PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Al-Azhar University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
- What is being tested?
- Letrozole tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 138 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The study will include women diagnosed with polycystic ovary syndrome (PCOS) based on the Rotterdam criteria, who are seeking infertility treatment and undergoing ovulation induction with letrozole for the first time. Participants will be women aged 18-40 years, recruited from the outpatient clinic at Al-Hussein University Hospital, a tertiary healthcare center in Egypt. All participants will undergo a comprehensive baseline assessment, including clinical evaluation, laboratory investigations, and transvaginal ultrasound before starting letrozole treatment. The study aims to identify potential predictors of letrozole resistance by comparing baseline characteristics between women who respond to treatment and those who do not.
Who may be able to join
- 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
Who cannot join
- Infertility due to other causes such as tubal obstruction or male factor infertility.
- Previous ovarian surgery or use of medications that could influence ovulation.
- Comorbidities such as uncontrolled diabetes, hyperprolactinemia, or thyroid dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Laboratory and Ultrasound Findings Between Letrozole-Resistant and Letrozole-Sensitive PCOS Patients in Egypt
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:
Read more
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.
- Being tested
- Letrozole tablets
- Keywords
- PCOS, letrozole
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole tabletsDrug
The intervention in this study is ovulation induction using letrozole, an aromatase inhibitor commonly used in women with polycystic ovary syndrome (PCOS) to stimulate ovulation. Participants will receive letrozole at an initial dose of 2.5 mg/day for five days, starting on day 3 of the menstrual cycle. If ovulation is not achieved, the dose will be incrementally increased up to a maximum of 7.5 mg/day over a maximum of three cycles. Ovulation will be monitored through serial transvaginal ultrasounds to assess follicular development, and confirmed by measuring mid-luteal serum progesterone levels (>3 ng/mL). Based on the response to letrozole, participants will be classified as either letrozole-sensitive (ovulatory) or letrozole-resistant (anovulatory) to identify potential predictors of resistance and improve individualized treatment strategies for PCOS-related infertility.
| Study group | Role | What they receive |
|---|---|---|
| PCOS patients | The study will include a single group of women diagnosed with polycystic ovary syndrome (PCOS) based on the Rotterdam criteria, who are undergoing ovulation induction with letrozole for the first time. Participants will be women aged 18-40 years attending the outpatient clinic at Al-Hussein University Hospital for infertility treatment. All participants will undergo a comprehensive baseline assessment, including clinical evaluation, laboratory investigations, and transvaginal ultrasound before starting letrozole therapy. After treatment, they will be classified into letrozole-sensitive or letrozole-resistant subgroups based on their ovulatory response. The study aims to identify potential predictors of letrozole resistance by comparing baseline characteristics between these two outcome-based subgroups. Receives: Drug: Letrozole tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.
This outcome measures the differences in baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Measured: At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline LH level between letrozole-sensitive and letrozole-resistant PCOS patients.
This outcome measures the differences in baseline LH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Measured: At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline LH/FSH ratio level between letrozole-sensitive and letrozole-resistant PCOS patients.
This outcome measures the differences in baseline LH/FSH ratio level between letrozole-sensitive and letrozole-resistant PCOS patients.
Measured: At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline AMH level between letrozole-sensitive and letrozole-resistant PCOS patients.
This outcome measures the differences in baseline AMH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Measured: At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline total testosterone level between letrozole-sensitive and letrozole-resistant PCOS patients.
This outcome measures the differences in baseline total testosterone level between letrozole-sensitive and letrozole-resistant PCOS patients.
Measured: At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline fasting insulin level between letrozole-sensitive and letrozole-resistant PCOS patients.
This outcome measures the differences in baseline fasting insulin level between letrozole-sensitive and letrozole-resistant PCOS patients.
Measured: At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline glucose level between letrozole-sensitive and letrozole-resistant PCOS patients.
This outcome measures the differences in baseline glucose level between letrozole-sensitive and letrozole-resistant PCOS patients.
Measured: At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline lipid profile between letrozole-sensitive and letrozole-resistant PCOS patients.
This outcome measures the differences in baseline lipid profile between letrozole-sensitive and letrozole-resistant PCOS patients.
Measured: At the end of cycle 3 of treatment (each cycle is 28 days).
Comparison of baseline antral follicle count between letrozole-sensitive and letrozole-resistant PCOS patients.
This outcome measures the differences in baseline antral follicle count between letrozole-sensitive and letrozole-resistant PCOS patients.
Measured: At the end of cycle 3 of treatment (each cycle is 28 days)
Comparison of baseline ovarian volume between letrozole-sensitive and letrozole-resistant PCOS patients.
This outcome measures the differences in baseline ovarian volume between letrozole-sensitive and letrozole-resistant PCOS patients.
Measured: At the end of cycle 3 of treatment (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy, Al-Azhar University
- Investigators
- Muhamed Alhagrasy, M.D., Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861803
- Sponsor's protocol ID
- Gyne19225
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study investigators will share de-identified individual participant data (IPD) related to baseline laboratory and ultrasound findings, ovulation outcomes, and relevant clinical parameters. The shared dataset will exclude any personally identifiable information to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laboratory and Ultrasound Findings Between Letrozole-Resistant and Letrozole-Sensitive PCOS Patients in Egypt
- ClinicalTrials.gov ID
- NCT06861803
- Acronym / sponsor ID
- Gyne19225
- Keywords
- PCOS, letrozole
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCOS patients | – | Drug: Letrozole tabletsThe study will include a single group of women diagnosed with polycystic ovary syndrome (PCOS) based on the Rotterdam criteria, who are undergoing ovulation induction with letrozole for the first time. Participants will be women aged 18-40 years attending the outpatient clinic at Al-Hussein University Hospital for infertility treatment. All participants will undergo a comprehensive baseline assessment, including clinical evaluation, laboratory investigations, and transvaginal ultrasound before starting letrozole therapy. After treatment, they will be classified into letrozole-sensitive or letrozole-resistant subgroups based on their ovulatory response. The study aims to identify potential predictors of letrozole resistance by comparing baseline characteristics between these two outcome-based subgroups. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study will include women diagnosed with polycystic ovary syndrome (PCOS) based on the Rotterdam criteria, who are seeking infertility treatment and undergoing ovulation induction with letrozole for the first time. Participants will be women aged 18-40 years, recruited from the outpatient clinic at Al-Hussein University Hospital, a tertiary healthcare center in Egypt. All participants will undergo a comprehensive baseline assessment, including clinical evaluation, laboratory investigations, and transvaginal ultrasound before starting letrozole treatment. The study aims to identify potential predictors of letrozole resistance by comparing baseline characteristics between women who respond to treatment and those who do not.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Infertility due to other causes such as tubal obstruction or male factor infertility.
- Previous ovarian surgery or use of medications that could influence ovulation.
- Comorbidities such as uncontrolled diabetes, hyperprolactinemia, or thyroid dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letrozole tabletsThe intervention in this study is ovulation induction using letrozole, an aromatase inhibitor commonly used in women with polycystic ovary syndrome (PCOS) to stimulate ovulation. Participants will receive letrozole at an initial dose of 2.5 mg/day for five days, starting on day 3 of the menstrual cycle. If ovulation is not achieved, the dose will be incrementally increased up to a maximum of 7.5 mg/day over a maximum of three cycles. Ovulation will be monitored through serial transvaginal ultrasounds to assess follicular development, and confirmed by measuring mid-luteal serum progesterone levels (>3 ng/mL). Based on the response to letrozole, participants will be classified as either letrozole-sensitive (ovulatory) or letrozole-resistant (anovulatory) to identify potential predictors of resistance and improve individualized treatment strategies for PCOS-related infertility. | Drug | PCOS patients |
Primary outcome
Comparison of baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline LH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline LH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline LH/FSH ratio level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline LH/FSH ratio level between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline AMH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline AMH level between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline total testosterone level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline total testosterone level between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline fasting insulin level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline fasting insulin level between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline glucose level between letrozole-sensitive and letrozole-resistant PCOS patients.
Time frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline glucose level between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline lipid profile between letrozole-sensitive and letrozole-resistant PCOS patients.
Time frame: At the end of cycle 3 of treatment (each cycle is 28 days).
This outcome measures the differences in baseline lipid profile between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline antral follicle count between letrozole-sensitive and letrozole-resistant PCOS patients.
Time frame: At the end of cycle 3 of treatment (each cycle is 28 days)
This outcome measures the differences in baseline antral follicle count between letrozole-sensitive and letrozole-resistant PCOS patients.
Comparison of baseline ovarian volume between letrozole-sensitive and letrozole-resistant PCOS patients.
Time frame: At the end of cycle 3 of treatment (each cycle is 28 days)
This outcome measures the differences in baseline ovarian volume between letrozole-sensitive and letrozole-resistant PCOS patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Yes. The study investigators will share de-identified individual participant data (IPD) related to baseline laboratory and ultrasound findings, ovulation outcomes, and relevant clinical parameters. The shared dataset will exclude any personally identifiable information to ensure participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhamed Alhagrasy, M.D. principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhamed Alhagrasy, M.D. (01017313413, MuhamedAhmed.216@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of baseline FSH level between letrozole-sensitive and letrozole-resistant PCOS patients. (time frame: At the end of cycle 3 of treatment (each cycle is 28 days).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.