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

NCT06405243 | Not Yet Recruiting Phase 3

• 1 other identifier: myoinositol/letrazol/pco
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; letrazole; myoinositol; L-arginine; Chromium

Outcome Measures

Primary Outcomes (1)

• ovulation

  trans-vaginal ultrasound shows dominant follicle more than 18mm

  3 cycles ( 3 months / one month for each cycle)

Study Arms (3)

myoinositol

EXPERIMENTAL

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

Drug: Myoinositol; Drug: Letrozole 2.5mg

chromium

EXPERIMENTAL

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

Drug: Chromium; Drug: Letrozole 2.5mg

L-arginine

EXPERIMENTAL

: 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.

Drug: l-arginine; Drug: Letrozole 2.5mg

Interventions

Myoinositol 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

Also known as: femtonex

myoinositol

Chromium 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

Also known as: chromax

chromium

l-arginine DRUG

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

Also known as: Blue ox

L-arginine

Letrozole 2.5mg DRUG

selective aromatase inhibitor

Also known as: femara

L-arginine; chromium; myoinositol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients with a history of systemic diseases such as liver, kidney, cardiovascular, diabetes (type I or II) or malignancy.
• Patients who consumed myoinositol, metformin, SGLT2 or drugs effecting insulin secretion or clomiphene citrate in the previous 2 months.
• \. Use of hormonal medications, lipid-lowering agents (statins, etc.), anti-obesity drugs or medications for weight loss in the previous 2 months.
• \. Patients with hormonal disorders such as hyperprolactinemia, hypo or hyperthyroidism or Cushing syndrome. 5. Presence of hypersensitivity to any of the study medications.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (2)

Beni-suef university Hospital

Banī Suwayf, 62511, Egypt

Location

Beni-suef university

Banī Suwayf, 62511, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Inositol; Chromium; Arginine; Letrozole

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Sara S Sara Salem

CONTACT

+201272842226; sara_abdallah100@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: May 8, 2024
• Study Start: June 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)