Polycystic Ovarian Syndrome (PCOS)NCT06793904
Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS
A study testing Aromatase inhibitor Letrozole in people with Polycystic Ovarian Syndrome (PCOS), run by Cairo University at 1 site in Egypt.
Trial summary
122 women diagnosed with PCOS seeking fertility in the fertility clinic at kasr Alainy hospital will be subjected to Homeostatic model assessment for insulin resistance 1 was calculated for all participants through the equation [glucose (mmol/L) × insulin (µU/L)]/22.5 while homeostatic model assessment for insulin… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome (PCOS)
- What is being tested?
- Aromatase inhibitor Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to Jan 2026
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-35 years
- duration of infertility 1-4 years
- PCOS
Who cannot join
- women with other causes of infertility (tubal factor assessed by laparoscopy or hysterosalpingogram, uterine cavity abnormality assessed by ultrasound or hysteroscopy or male factor assessed by seme analysis),
- endometriosis,
- ovarian cysts,
- endocrinological abnormalities (Diabetes mellitus, hypothalamic, pituitary or thyroid disorders, or hyperprolactinemia),
- women with history of poor ovarian response or ovarian hyperstimulation
- women with chronic diseases, chromosomal, autoimmune or coagulation defects, abnormal leucocytic count or other inflammatory markers
- Women with contraindications to pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12111
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Official title: Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS: A Prospective Cohort Study
122 women diagnosed with PCOS seeking fertility in the fertility clinic at kasr Alainy hospital will be subjected to Homeostatic model assessment for insulin resistance 1 was calculated for all participants through the equation [glucose (mmol/L) × insulin (µU/L)]/22.5 while homeostatic model assessment for insulin resistance 2 was calculated by the HOMA2 calculator. All women will be subjected to induction of ovulation using the Aromatase inhibitor Letrozole 2.5 mg tab twice daily from the 3rd day of the cycle for 5 days . Ultrasound follow up of follicular growth will be performed till dominant follicular size reaches 18-22 mm. FSH preparations will be introduced as needed.
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Being tested
- Aromatase inhibitor 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.
Aromatase inhibitor LetrozoleDrug
2.5 mg tab twice daily from the 3rd day of the cycle for 5 days
| Study group | Role | What they receive |
|---|---|---|
| PCOS | Experimental | Homeostatic model assessment for insulin resistance 1 will be calculated for all participants through the equation [glucose (mmol/L) × insulin (µU/L)]/22.5 while homeostatic model assessment for insulin resistance 2 will be calculated by the HOMA2 calculator. All women will be subjected to induction of ovulation using the Aromatase inhibitor Letrozole 2.5 mg tab twice daily from the 3rd day of the cycle for 5 days . Ultrasound follow up of follicular growth will be performed till dominant follicular size reaches 18-22 mm. FSH preparations were introduced as needed. Receives: Drug: Aromatase inhibitor Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with successful ovulation
the dominant follicle reached 18 or more mm
Measured: 5 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Feb 2025
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian Syndrome (PCOS)Studies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793904
- Sponsor's protocol ID
- N 364-2024
- Other IDs
- Cairo university
- Status last verified
- Feb 2025
- First submitted
- 21 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06793904
- Acronym / sponsor ID
- N 364-2024
- Conditions
- Polycystic Ovarian Syndrome (PCOS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 27 Jan 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.
122 women diagnosed with PCOS seeking fertility in the fertility clinic at kasr Alainy hospital will be subjected to Homeostatic model assessment for insulin resistance 1 was calculated for all participants through the equation [glucose (mmol/L) × insulin (µU/L)]/22.5 while homeostatic model assessment for insulin resistance 2 was calculated by the HOMA2 calculator. All women will be subjected to induction of ovulation using the Aromatase inhibitor Letrozole 2.5 mg tab twice daily from the 3rd day of the cycle for 5 days . Ultrasound follow up of follicular growth will be performed till dominant follicular size reaches 18-22 mm. FSH preparations will be introduced as needed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCOS | Experimental | Drug: Aromatase inhibitor LetrozoleHomeostatic model assessment for insulin resistance 1 will be calculated for all participants through the equation [glucose (mmol/L) × insulin (µU/L)]/22.5 while homeostatic model assessment for insulin resistance 2 will be calculated by the HOMA2 calculator. All women will be subjected to induction of ovulation using the Aromatase inhibitor Letrozole 2.5 mg tab twice daily from the 3rd day of the cycle for 5 days . Ultrasound follow up of follicular growth will be performed till dominant follicular size reaches 18-22 mm. FSH preparations were introduced as needed. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-35 years
- duration of infertility 1-4 years
- PCOS
Key exclusion criteria (7 listed)
- women with other causes of infertility (tubal factor assessed by laparoscopy or hysterosalpingogram, uterine cavity abnormality assessed by ultrasound or hysteroscopy or male factor assessed by seme analysis),
- endometriosis,
- ovarian cysts,
- endocrinological abnormalities (Diabetes mellitus, hypothalamic, pituitary or thyroid disorders, or hyperprolactinemia),
- women with history of poor ovarian response or ovarian hyperstimulation
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 |
|---|---|---|
| Aromatase inhibitor Letrozole2.5 mg tab twice daily from the 3rd day of the cycle for 5 days | Drug | PCOS |
Primary outcome
Number of participants with successful ovulation
Time frame: 5 days after treatment
the dominant follicle reached 18 or more mm
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 5 Feb 2025.
- Individual participant dataSharing planned: Undecided. upon reasonable request
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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.
Ahmed Maged, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatase inhibitor Letrozole in people with Polycystic Ovarian Syndrome (PCOS), run by Cairo 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Feb 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 Ahmed Maged, MD (01005227404, dr_ahmedmaged08@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with successful ovulation (time frame: 5 days after treatment). 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 5 Feb 2025.