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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405243
• Other study ID #: myoinositol/letrazol/pco
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 30, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Beni-Suef University
• Contact: Sara S Sara Salem
• Phone: +201272842226
• Email: sara_abdallah100[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• 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
• 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
• l-arginine
new antioxidant that minimizes the inflammatory reaction, the hormonal imbalance, and the metabolic disturbances in PCO
• Letrozole 2.5mg
selective aromatase inhibitor

Locations

Country	Name	City	State
Egypt	Beni-suef university	Bani Suwayf
Egypt	Beni-suef university Hospital	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ovulation	trans-vaginal ultrasound shows dominant follicle more than 18mm	3 cycles ( 3 months / one month for each cycle)