Myoinositol, L-arginine and Chromium With Letrozole for Ovulation Induction in Polycystic Ovarian Syndrome Patients

NCT ID: NCT06405243

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2024-12-31

Brief Summary

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The aim of the study is to compare and assess the efficacy of combined letrozole with myoinositol, chromium, or L-arginine in infertile women with PCOS. This study will help in the investigation of alternative therapeutic modalities for fertility improvement in polycystic ovarian syndrome

Detailed Description

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d prospective Study Trial. We will recruit patients diagnosed with PCOS according to Rotterdam criteria of PCOS and who present to outpatient clinics at Beni-Suef University Hospital. Infertile women will be randomized to receive letrozole (2.5 mg for 5 days from 3rd day of patients' menstrual cycle) combination with myoinositol, chromium or L-arginine

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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myoinositol

patients will be treated for 12 weeks myoinositol (2gm /day) with ovulation induction by letrazole regimen for 3 consecutive cycl

Group Type EXPERIMENTAL

Myoinositol

Intervention Type DRUG

Myoinositol decreases insulin resistance and consequently increased intracellular glucose uptake, restore the metabolic profile and induce ovulation in PCOS patients with infertility, in addition to its good safety profile

Letrozole 2.5mg

Intervention Type DRUG

selective aromatase inhibitor

chromium

patients will be treated for 12 weeks chromium ( 281.569 mcg/ day) with ovulation induction by letrazole regimen for 3 consecutive cycles

Group Type EXPERIMENTAL

Chromium

Intervention Type DRUG

chromium picolinate may potentiates the therapeutic effect of letrozol on pituitary hormones (FSH and LH), improvement of ovulation, normalization of Estrogen level, improvement of endometrial thickness related to ovulation

Letrozole 2.5mg

Intervention Type DRUG

selective aromatase inhibitor

L-arginine

: patients will be treated for 12 weeks with L-arginine (500 mg once daily in the morning) with ovulation induction by letrazole regimen for 3 consecutive cycles.

Group Type EXPERIMENTAL

l-arginine

Intervention Type DRUG

new antioxidant that minimizes the inflammatory reaction, the hormonal imbalance, and the metabolic disturbances in PCO

Letrozole 2.5mg

Intervention Type DRUG

selective aromatase inhibitor

Interventions

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Myoinositol

Myoinositol decreases insulin resistance and consequently increased intracellular glucose uptake, restore the metabolic profile and induce ovulation in PCOS patients with infertility, in addition to its good safety profile

Intervention Type DRUG

Chromium

chromium picolinate may potentiates the therapeutic effect of letrozol on pituitary hormones (FSH and LH), improvement of ovulation, normalization of Estrogen level, improvement of endometrial thickness related to ovulation

Intervention Type DRUG

l-arginine

new antioxidant that minimizes the inflammatory reaction, the hormonal imbalance, and the metabolic disturbances in PCO

Intervention Type DRUG

Letrozole 2.5mg

selective aromatase inhibitor

Intervention Type DRUG

Other Intervention Names

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femtonex chromax Blue ox femara

Eligibility Criteria

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Inclusion Criteria

* Primary or secondary infertility associated with PCOS as defined by the revised Rotterdam criteria
* Normal values of the following laboratory tests: thyroid function, prolactin level, and husband's sperm analysis and hysterosalpingography

Exclusion Criteria

1. Patients with a history of systemic diseases such as liver, kidney, cardiovascular, diabetes (type I or II) or malignancy.
2. Patients who consumed myoinositol, metformin, SGLT2 or drugs effecting insulin secretion or clomiphene citrate in the previous 2 months.

3\. Use of hormonal medications, lipid-lowering agents (statins, etc.), anti-obesity drugs or medications for weight loss in the previous 2 months.

4\. Patients with hormonal disorders such as hyperprolactinemia, hypo or hyperthyroidism or Cushing syndrome. 5. Presence of hypersensitivity to any of the study medications.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beni-suef university Hospital

Banī Suwayf, , Egypt

Site Status

Beni-suef university

Banī Suwayf, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Sara S Sara Salem

Role: CONTACT

+201272842226

Facility Contacts

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Beni Suef University

Role: primary

0020822318605 ext. 2

Other Identifiers

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myoinositol/letrazol/pco

Identifier Type: -

Identifier Source: org_study_id

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