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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Al-Azhar University Hospital Assuit branch

    Asyut

Other trials in Egypt

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.

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 groups in NCT07873294
Study groupRoleWhat they receive
Group of LetrozoleActive comparatorAbout 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 InositolActive comparatorAbout 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.

  1. 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.

  1. First posted14 Oct 2026
  2. Study start1 Aug 2025
  3. Primary completion1 Aug 2026
  4. Study completion10 Aug 2026

Resources

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)
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

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.

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