Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic Ovary Syndrome, letrazole, myoinositol, L-arginine, Chromium
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
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
Interventions
DRUGMyoinositol
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
DRUGChromium
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
DRUGl-arginine
new antioxidant that minimizes the inflammatory reaction, the hormonal imbalance, and the metabolic disturbances in PCO
DRUGLetrozole 2.5mg
selective aromatase inhibitor
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ovulation | 3 cycles ( 3 months / one month for each cycle) | trans-vaginal ultrasound shows dominant follicle more than 18mm |
Countries
Egypt
Contacts
Primary ContactSara S Sara Salem
Outcome results
None listed