Polycystic Ovary Syndrome (PCOS) WomenPhase 2NCT07635082
Extended Letrozole Protocol Versus Letrozole Plus Inositol for Induction of Ovulation in Letrozole Resistant PCOS Women
A Phase 2 study testing ELP (Extended Letrozole Protocol) and LIP (Letrozole + Inositol Protocol) in people with Polycystic Ovary Syndrome (PCOS) Women and Polycystic Ovary Syndrome, run by Eman Basuni Ebrahim Mowad at 1 site in Egypt.
Trial summary
Extended letrozole protocol versus letrozole plus Inositol for Induction of ovulation in letrozole resistant PCOS Women Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS) Women, Polycystic Ovary Syndrome
- What is being tested?
- ELP (Extended Letrozole Protocol) and LIP (Letrozole + Inositol Protocol)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.
- Letrozole-resistant PCOS patients who failed to ovulate after receiving letrozole 5 mg daily for 5 days for three consecutive cycles.
- Age 18 to 35 years.
- Body mass index (BMI) ≤ 30 kg/m².
- Normal uterine cavity and patent fallopian tubes confirmed by hysterosalpingography (HSG) and/or laparoscopy.
- Partner with normal semen analysis.
- Willing and able to provide informed consent.
Who cannot join
- Thyroid dysfunction.
- Hyperprolactinemia.
- Diabetes mellitus.
- Congenital adrenal hyperplasia.
- Adrenal causes of hyperandrogenism.
- Use of insulin-sensitizing medications (e.g., metformin) during the study period.
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- Chronic liver disease.
- Chronic kidney disease.
- Contraindications to pregnancy.
- Contraindications or hypersensitivity to inositol or letrozole.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh University Hospital
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511
About this study
Extended letrozole protocol versus letrozole plus Inositol for Induction of ovulation in letrozole resistant PCOS Women
- Being tested
- ELP (Extended Letrozole Protocol), LIP (Letrozole + Inositol Protocol)
- 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.
ELP (Extended Letrozole Protocol)Drug
? ELP (Extended Letrozole Protocol)
Participants allocated to this arm will receive letrozole 5 mg orally once daily, starting on day 2 of the menstrual cycle and continued for 7 consecutive days.
Follicular development will be monitored using transvaginal ultrasonography every 48 hours starting after the last dose of letrozole until confirmation of ovulation.
When at least one dominant follicle reaches a mean diameter of 18-20 mm, human chorionic gonadotropin (hCG) will be administered to trigger ovulation. Timed intercourse will be advised accordingly.
Endometrial thickness will be measured on the day of ovulation trigger. This protocol may be repeated for up to 3 consecutive cycles in case ovulation is not achieved.
LIP (Letrozole + Inositol Protocol)Drug
? LIP (Letrozole + Inositol Protocol)
Participants allocated to this arm will receive myo-inositol 2 g orally twice daily for a duration of 3 months prior to ovulation induction.
In the subsequent cycle, letrozole 5 mg orally once daily will be administered starting on day 2 of the menstrual cycle for 5 consecutive days.
Follicular monitoring will be performed using transvaginal ultrasonography every 48 hours after the last dose of letrozole until ovulation is confirmed.
Ovulation will be triggered using hCG injection when at least one follicle reaches 18-20 mm in diameter, followed by timed intercourse.
Compliance with inositol intake and any adverse effects will be documented throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Extended Letrozole Protocol (7 days | Placebo comparator | Not described Receives: Drug: ELP (Extended Letrozole Protocol) |
| Letrozole + Inositol Protocol | Experimental | Not described Receives: Drug: LIP (Letrozole + Inositol Protocol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation Rate
The proportion of participants achieving ovulation after treatment with either an extended letrozole protocol (5 mg daily for 7 days) or letrozole plus inositol protocol in letrozole-resistant PCOS women.
Measured: At the end of Cycle 1 (each treatment cycle is 28 days).
Secondary outcomes (2)
Spontaneous Ovulation Rate
The proportion of participants who achieve spontaneous ovulation during the study period.
Measured: Up to 3 months after treatment initiation.
Clinical Pregnancy Rate
The proportion of participants with clinical pregnancy confirmed by transvaginal ultrasonographic visualization of a gestational sac.
Measured: Up to 12 weeks after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Feb 2024
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS) WomenStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eman Basuni Ebrahim Mowad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman Basuni Ebrahim Mowad, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635082
- Sponsor's protocol ID
- Induction of ovulation
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Letrozole Protocol Versus Letrozole Plus Inositol for Induction of Ovulation in Letrozole Resistant PCOS Women
- ClinicalTrials.gov ID
- NCT07635082
- Acronym / sponsor ID
- Induction of ovulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eman Basuni Ebrahim MowadUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 9 Jun 2026 (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.
Extended letrozole protocol versus letrozole plus Inositol for Induction of ovulation in letrozole resistant PCOS Women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Letrozole Protocol (7 days | Placebo comparator | Drug: ELP (Extended Letrozole Protocol) |
| Letrozole + Inositol Protocol | Experimental | Drug: LIP (Letrozole + Inositol Protocol) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.
- Letrozole-resistant PCOS patients who failed to ovulate after receiving letrozole 5 mg daily for 5 days for three consecutive cycles.
- Age 18 to 35 years.
- Body mass index (BMI) ≤ 30 kg/m².
- Normal uterine cavity and patent fallopian tubes confirmed by hysterosalpingography (HSG) and/or laparoscopy.
Key exclusion criteria (10 listed)
- Thyroid dysfunction.
- Hyperprolactinemia.
- Diabetes mellitus.
- Congenital adrenal hyperplasia.
- Adrenal causes of hyperandrogenism.
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 |
|---|---|---|
| ELP (Extended Letrozole Protocol)? ELP (Extended Letrozole Protocol) Participants allocated to this arm will receive letrozole 5 mg orally once daily, starting on day 2 of the menstrual cycle and continued for 7 consecutive days. Follicular development will be monitored using transvaginal ultrasonography every 48 hours starting after the last dose of letrozole until confirmation of ovulation. When at least one dominant follicle reaches a mean diameter of 18-20 mm, human chorionic gonadotropin (hCG) will be administered to trigger ovulation. Timed intercourse will be advised accordingly. Endometrial thickness will be measured on the day of ovulation trigger. This protocol may be repeated for up to 3 consecutive cycles in case ovulation is not achieved. | Drug | Extended Letrozole Protocol (7 days |
| LIP (Letrozole + Inositol Protocol)? LIP (Letrozole + Inositol Protocol) Participants allocated to this arm will receive myo-inositol 2 g orally twice daily for a duration of 3 months prior to ovulation induction. In the subsequent cycle, letrozole 5 mg orally once daily will be administered starting on day 2 of the menstrual cycle for 5 consecutive days. Follicular monitoring will be performed using transvaginal ultrasonography every 48 hours after the last dose of letrozole until ovulation is confirmed. Ovulation will be triggered using hCG injection when at least one follicle reaches 18-20 mm in diameter, followed by timed intercourse. Compliance with inositol intake and any adverse effects will be documented throughout the study period. | Drug | Letrozole + Inositol Protocol |
Primary outcome
Ovulation Rate
Time frame: At the end of Cycle 1 (each treatment cycle is 28 days).
The proportion of participants achieving ovulation after treatment with either an extended letrozole protocol (5 mg daily for 7 days) or letrozole plus inositol protocol in letrozole-resistant PCOS women.
2 secondary outcomes
Spontaneous Ovulation Rate
Time frame: Up to 3 months after treatment initiation.
Clinical Pregnancy Rate
Time frame: Up to 12 weeks after treatment initiation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ELP (Extended Letrozole Protocol) and LIP (Letrozole + Inositol Protocol) in people with Polycystic Ovary Syndrome (PCOS) Women and Polycystic Ovary Syndrome, run by Eman Basuni Ebrahim Mowad 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 9 Jun 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation Rate (time frame: At the end of Cycle 1 (each treatment cycle is 28 days).). 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 9 Jun 2026.