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

Beni-Suef University

Status and phase: Not yet enrolling; Phase 3

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Myoinositol; Drug: Chromium; Drug: Letrozole 2.5mg; Drug: l-arginine

Study type: Interventional

Funder types: Other

Identifiers

NCT06405243

myoinositol/letrazol/pco

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

myoinositol

Experimental group

Description:

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

Treatment:

Drug: Letrozole 2.5mg

Drug: Myoinositol

chromium

Experimental group

Description:

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

Treatment:

Drug: Letrozole 2.5mg

Drug: Chromium

L-arginine

Experimental group

Description:

: 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.

Treatment:

Drug: l-arginine

Drug: Letrozole 2.5mg