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Trial Title:
Myoinositol, L-arginine and Chromium With Letrozole for Ovulation Induction in Polycystic Ovarian Syndrome Patients
NCT ID:
NCT06405243
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Chromium
Inositol
Letrozole
Conditions: Keywords:
Polycystic Ovary Syndrome
letrazole
myoinositol
L-arginine
Chromium
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Myoinositol
Description:
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
Arm group label:
myoinositol
Other name:
femtonex
Intervention type:
Drug
Intervention name:
Chromium
Description:
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
Arm group label:
chromium
Other name:
chromax
Intervention type:
Drug
Intervention name:
l-arginine
Description:
new antioxidant that minimizes the inflammatory reaction, the hormonal imbalance, and the
metabolic disturbances in PCO
Arm group label:
L-arginine
Other name:
Blue ox
Intervention type:
Drug
Intervention name:
Letrozole 2.5mg
Description:
selective aromatase inhibitor
Arm group label:
L-arginine
Arm group label:
chromium
Arm group label:
myoinositol
Other name:
femara
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
Detailed 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
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beni-suef university Hospital
Address:
City:
Banī Suwayf
Zip:
62511
Country:
Egypt
Facility:
Name:
Beni-suef university
Address:
City:
Banī Suwayf
Zip:
62511
Country:
Egypt
Contact:
Last name:
Beni Suef University
Phone:
0020822318605
Phone ext:
2
Email:
fom@med.bsu.edu.eg
Start date:
June 30, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Beni-Suef University
Agency class:
Other
Source:
Beni-Suef University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06405243
