Polycystic Ovary SyndromeNCT07873294
Letrozole Versus Letrozole and Inositol
A study testing Letrozole tablets in people with Polycystic Ovary Syndrome, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders affecting women of reproductive age. Its prevalence varies considerably according to the population studied and the diagnostic criteria applied. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Letrozole tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 10 Aug 2026
- Phase
- Interventional
- 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
- Diagnosis of PCOS according to the Rotterdam criteria, requiring the presence of at least two of the following three features: oligo-ovulation or anovulation; clinical and/or biochemical hyperandrogenism; Polycystic ovarian morphology on ultrasonography.
- According to the prespecified study protocol, polycystic ovarian morphology was defined as the presence of ≥12 follicles measuring 2-9 mm in diameter and/or ovarian volume >10 mL in at least one ovary.
- BMI <30 kg/m².
- Documented anovulation, supported by a luteal serum progesterone concentration <3 ng/mL.
- Bilateral tubal patency confirmed by hysterosalpingography.
- Absence of another identifiable female infertility factor.
- Normal semen analysis of the male partner.
Who cannot join
- Persistent hyperprolactinemia.
- Congenital adrenal hyperplasia or other adrenal disorders associated with androgen excess.
- Pituitary insufficiency.
- Clinically significant thyroid dysfunction affecting ovulation.
- Previous ovarian surgery.
- Use of ovulation-induction agents, insulin-sensitizing medications or other oral hypoglycemic agents, hormonal contraceptives, or anti-androgen medications within 60 days before enrollment.
- Known hypersensitivity or contraindication to letrozole or inositol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Letrozole Versus Letrozole and Inositol in Ovulation Induction in PCO Patients
Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders affecting women of reproductive age. Its prevalence varies considerably according to the population studied and the diagnostic criteria applied. A recent global systematic review and meta-analysis estimated the prevalence of PCOS among adult women to be approximately 12.1% according to the Rotterdam criteria, compared with 7.9% using the National Institutes of Health (NIH) criteria and 12.7% using the Androgen Excess-PCOS Society criteria.
Read the detailed description
PCOS is a heterogeneous disorder characterized primarily by ovulatory dysfunction, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology, after exclusion of other disorders that may present with similar features.
Clinically, affected women may present with irregular menstrual cycles, hirsutism, acne, infertility, and weight-related problems. In addition to its reproductive manifestations, PCOS is associated with important metabolic abnormalities, particularly insulin resistance, compensatory hyperinsulinemia, dyslipidemia, and an increased risk of impaired glucose tolerance and type 2 diabetes mellitus.
The pathophysiology of PCOs is complex and multifactorial and involves interactions among genetic susceptibility, neuroendocrine dysfunction, ovarian steroidogenesis, metabolic abnormalities, and environmental influences.Hyperandrogenism and insulin resistance are considered major components of this pathophysiological network. Increased ovarian androgen production contributes to abnormal follicular development and ovulatory dysfunction, whereas insulin resistance and the resulting hyperinsulinemia may further stimulate androgen production by ovarian theca cells and reduce hepatic sex hormone-binding globulin synthesis, thereby increasing circulating bioavailable androgens.
These mechanisms may create a self-perpetuating relationship between metabolic dysfunction, hyperandrogenism, and impaired follicular maturation.Ovulatory dysfunction is one of the principal causes of infertility among women with PCOS, and PCOS has been reported to account for up to approximately 80% of cases of anovulatory infertility.
Consequently, restoration of ovulation represents a major therapeutic objective in women with PCOS who desire pregnancy. Current international evidence-based recommendations identify letrozole as the first-line pharmacological treatment for ovulation induction in women with PCOS-associated anovulatory infertility in the absence of other infertility factors.
Letrozole is a third-generation aromatase inhibitor that temporarily suppresses the conversion of androgens to estrogens. The resulting reduction in circulating estrogen diminishes estrogen-mediated negative feedback at the hypothalamic-pituitary level, leading to increased endogenous follicle-stimulating hormone (FSH) secretion and subsequent recruitment and development of ovarian follicles.
Unlike clomiphene citrate, letrozole has a relatively short half-life and does not exert prolonged anti-estrogenic effects on the endometrium or cervical mucus, which may contribute to its favorable reproductive outcomes. Nevertheless, despite its established efficacy, a proportion of women with PCOS fail to develop a dominant follicle or achieve ovulation following conventional letrozole treatment. Such patients are commonly described as having letrozole-resistant PCOS, although the precise definition of letrozole resistance and the optimal management strategy remain areas of ongoing investigation.
Several therapeutic modifications have therefore been investigated in an attempt to improve ovarian responsiveness in women who do not respond adequately to conventional letrozole regimens. One approach is to target the metabolic abnormalities that may contribute to impaired ovarian responsiveness. Inositols, particularly myo-inositol (MI) and D-chiro-inositol (DCI), have attracted considerable interest because of their roles as intracellular second messengers in insulin-signaling pathways and their potential influence on ovarian steroidogenesis and follicular function.
MI is involved in glucose uptake and FSH signaling within the ovary, whereas DCI participates in insulin-mediated metabolic pathways and may influence ovarian androgen synthesis Abnormalities in inositol metabolism have therefore been proposed as one potential link between insulin resistance and reproductive dysfunction in PCOs.
From a pathophysiological perspective, combining inositol supplementation with letrozole could theoretically provide complementary effects in women with PCOS. Letrozole primarily promotes follicular recruitment through transient estrogen suppression and increased endogenous FSH secretion, whereas inositol supplementation may improve insulin signaling and potentially modify the metabolic and hormonal ovarian environment. Improvement in insulin sensitivity and reduction of compensatory hyperinsulinemia could theoretically decrease excessive ovarian androgen production and thereby enhance follicular responsiveness.
Nevertheless, robust evidence demonstrating that the addition of inositol to letrozole is superior to optimized letrozole therapy alone, particularly among women with documented letrozole resistance, remains insufficient. The benefit of this combined strategy therefore requires further evaluation in appropriately designed comparative clinical studies.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Letrozole tablets
- 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
Also called Inositol tablets
to compare the efficacy of the letrozole and letrozole combined with inositol for ovulation induction in women complaining from polycystic ovarian syndrome
| Study group | Role | What they receive |
|---|---|---|
| Group of Letrozole | Active comparator | About 50 women suffered from Poly Cystic Ovarian Syndrome and received Letrozole only, 5mg daily for 5 days, from day 3 of the cycle up to 7th day for 3 cycles for Induction of Ovulation Receives: Drug: Letrozole tablets |
| Group of Letrozole and Inositol | Active comparator | About 50 women suffered from Poly Cystic Ovarian Syndrome and received Letrozole as 5mg daily for 5 days, from day 3 of the cycle up to 7th day for 3 cycles and 2 gram of Inositol (24.3mg) Inositol ( 40:1) twice daily for 3 months. In the last cycle for Induction of Ovulation Receives: Drug: Letrozole tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Induction of ovulation treatment
Assessment the women whom suffered from Poly Cystic Ovary Syndrome and subjected to the treatment by Inositol and letrozole drugs for induction of ovulation achieved by measuring the levels of follicle-stimulating hormone (FSH)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Aug 2025
- Primary completion1 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Alaa El-Deen, Al-Azhar University
- Investigators
- Manal Gaber Abdelati, M.D, Study chair, Professor of Obstetrics and Gynecology Faculty of Medicine for Boys,Assiut Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873294
- Sponsor's protocol ID
- Ovulation Induction
- Status last verified
- Aug 2025
- First submitted
- 18 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole Versus Letrozole and Inositol in Ovulation Induction in PCO Patients
- ClinicalTrials.gov ID
- NCT07873294
- Acronym / sponsor ID
- Ovulation Induction
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 14 Oct 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.
Polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders affecting women of reproductive age. Its prevalence varies considerably according to the population studied and the diagnostic criteria applied. A recent global systematic review and meta-analysis estimated the prevalence of PCOS among adult women to be approximately 12.1% according to the Rotterdam criteria, compared with 7.9% using the National Institutes of Health (NIH) criteria and 12.7% using the Androgen Excess-PCOS Society criteria.
Detailed description
PCOS is a heterogeneous disorder characterized primarily by ovulatory dysfunction, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology, after exclusion of other disorders that may present with similar features.
Clinically, affected women may present with irregular menstrual cycles, hirsutism, acne, infertility, and weight-related problems. In addition to its reproductive manifestations, PCOS is associated with important metabolic abnormalities, particularly insulin resistance, compensatory hyperinsulinemia, dyslipidemia, and an increased risk of impaired glucose tolerance and type 2 diabetes mellitus.
The pathophysiology of PCOs is complex and multifactorial and involves interactions among genetic susceptibility, neuroendocrine dysfunction, ovarian steroidogenesis, metabolic abnormalities, and environmental influences.Hyperandrogenism and insulin resistance are considered major components of this pathophysiological network. Increased ovarian androgen production contributes to abnormal follicular development and ovulatory dysfunction, whereas insulin resistance and the resulting hyperinsulinemia may further stimulate androgen production by ovarian theca cells and reduce hepatic sex hormone-binding globulin synthesis, thereby increasing circulating bioavailable androgens.
These mechanisms may create a self-perpetuating relationship between metabolic dysfunction, hyperandrogenism, and impaired follicular maturation.Ovulatory dysfunction is one of the principal causes of infertility among women with PCOS, and PCOS has been reported to account for up to approximately 80% of cases of anovulatory infertility.
Consequently, restoration of ovulation represents a major therapeutic objective in women with PCOS who desire pregnancy. Current international evidence-based recommendations identify letrozole as the first-line pharmacological treatment for ovulation induction in women with PCOS-associated anovulatory infertility in the absence of other infertility factors.
Letrozole is a third-generation aromatase inhibitor that temporarily suppresses the conversion of androgens to estrogens. The resulting reduction in circulating estrogen diminishes estrogen-mediated negative feedback at the hypothalamic-pituitary level, leading to increased endogenous follicle-stimulating hormone (FSH) secretion and subsequent recruitment and development of ovarian follicles.
Unlike clomiphene citrate, letrozole has a relatively short half-life and does not exert prolonged anti-estrogenic effects on the endometrium or cervical mucus, which may contribute to its favorable reproductive outcomes. Nevertheless, despite its established efficacy, a proportion of women with PCOS fail to develop a dominant follicle or achieve ovulation following conventional letrozole treatment. Such patients are commonly described as having letrozole-resistant PCOS, although the precise definition of letrozole resistance and the optimal management strategy remain areas of ongoing investigation.
Several therapeutic modifications have therefore been investigated in an attempt to improve ovarian responsiveness in women who do not respond adequately to conventional letrozole regimens. One approach is to target the metabolic abnormalities that may contribute to impaired ovarian responsiveness. Inositols, particularly myo-inositol (MI) and D-chiro-inositol (DCI), have attracted considerable interest because of their roles as intracellular second messengers in insulin-signaling pathways and their potential influence on ovarian steroidogenesis and follicular function.
MI is involved in glucose uptake and FSH signaling within the ovary, whereas DCI participates in insulin-mediated metabolic pathways and may influence ovarian androgen synthesis Abnormalities in inositol metabolism have therefore been proposed as one potential link between insulin resistance and reproductive dysfunction in PCOs.
From a pathophysiological perspective, combining inositol supplementation with letrozole could theoretically provide complementary effects in women with PCOS. Letrozole primarily promotes follicular recruitment through transient estrogen suppression and increased endogenous FSH secretion, whereas inositol supplementation may improve insulin signaling and potentially modify the metabolic and hormonal ovarian environment. Improvement in insulin sensitivity and reduction of compensatory hyperinsulinemia could theoretically decrease excessive ovarian androgen production and thereby enhance follicular responsiveness.
Nevertheless, robust evidence demonstrating that the addition of inositol to letrozole is superior to optimized letrozole therapy alone, particularly among women with documented letrozole resistance, remains insufficient. The benefit of this combined strategy therefore requires further evaluation in appropriately designed comparative clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of Letrozole | Active comparator | Drug: Letrozole tabletsAbout 50 women suffered from Poly Cystic Ovarian Syndrome and received Letrozole only, 5mg daily for 5 days, from day 3 of the cycle up to 7th day for 3 cycles for Induction of Ovulation |
| Group of Letrozole and Inositol | Active comparator | Drug: Letrozole tabletsAbout 50 women suffered from Poly Cystic Ovarian Syndrome and received Letrozole as 5mg daily for 5 days, from day 3 of the cycle up to 7th day for 3 cycles and 2 gram of Inositol (24.3mg) Inositol ( 40:1) twice daily for 3 months. In the last cycle for Induction of Ovulation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of PCOS according to the Rotterdam criteria, requiring the presence of at least two of the following three features: oligo-ovulation or anovulation; clinical and/or biochemical hyperandrogenism; Polycystic ovarian morphology on ultrasonography.
- According to the prespecified study protocol, polycystic ovarian morphology was defined as the presence of ≥12 follicles measuring 2-9 mm in diameter and/or ovarian volume >10 mL in at least one ovary.
- BMI <30 kg/m².
- Documented anovulation, supported by a luteal serum progesterone concentration <3 ng/mL.
- Bilateral tubal patency confirmed by hysterosalpingography.
Key exclusion criteria (7 listed)
- Persistent hyperprolactinemia.
- Congenital adrenal hyperplasia or other adrenal disorders associated with androgen excess.
- Pituitary insufficiency.
- Clinically significant thyroid dysfunction affecting ovulation.
- Previous ovarian surgery.
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 tabletsAlso: Inositol tabletsto compare the efficacy of the letrozole and letrozole combined with inositol for ovulation induction in women complaining from polycystic ovarian syndrome | Drug | Group of Letrozole, Group of Letrozole and Inositol |
Primary outcome
Number of participants with Induction of ovulation treatment
Time frame: 3 Months
Assessment the women whom suffered from Poly Cystic Ovary Syndrome and subjected to the treatment by Inositol and letrozole drugs for induction of ovulation achieved by measuring the levels of follicle-stimulating hormone (FSH)
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 14 Oct 2026.
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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.
Manal Gaber Abdelati, M.D study chair
Professor of Obstetrics and Gynecology Faculty of Medicine for Boys,Assiut Al-Azhar 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 Letrozole tablets in people with Polycystic Ovary Syndrome, 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 7 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: finished, as of the sponsor's last update on 14 Oct 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. 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?
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?
Number of participants with Induction of ovulation treatment (time frame: 3 Months). 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 14 Oct 2026.