Polycystic Ovary Syndrome, Infertility
Conditions
Keywords
Inositol, Letrozol, PCOS
Brief summary
Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways.Thiss study compares between the effect of inositol and metformin in letrozol resistant PCOS women.
Detailed description
Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age .Furthermore, impaired glucose tolerance affects 30 - 40 % of women with PCOS and the pathophysiology of insulin resistance appears to be linked to a malfunction in the insulin signalling system. Insulin-sensitizing substances, including the B-complex vitamin inositol and its stereoisomers (myo-inositol and D-chiro-inositol )have therefore been investigated as a potential treatment for PCOS. Letrozole is the recommended medication for ovulation induction in PCOS-related infertility since it produces higher pregnancy and live birth rates than Clomphine Citrate. Alternative regimens, such as two-step, higher, and prolonged doses, may be necessary for women who are not responding to the standard letrozole dosage. However, some women might not respond to letrozole even at the highest dosage. Inositols are produced by the human body and are a member of the vitamin B complex group.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways. They positively influence menstrual cycle regularity, carbohydrate metabolism, and the clinical and laboratory symptoms of hyperandrogenism (e.g., free testosterone, total testosterone, SHBG).
Interventions
DRUGMyoinositol
Myo-inositol 2 g orally twice daily (4 g/day) for 8 weeks as metabolic priming, followed by letrozole 7.5 mg/day orally on cycle days 3-7 for three consecutive cycles. Folic acid 400 µg/day is administered throughout the study.
DRUGMetformin
Metformin initiated at 500 mg orally once daily and increased by 500 mg weekly as tolerated to a target dose of 1500 mg/day, administered for 8 weeks as metabolic priming, followed by letrozole 7.5 mg/day orally on cycle days 3-7 for three consecutive cycles. Folic acid 400 µg/day is administered throughout the study.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label trial. Participants and dispensing staff are not masked to treatment assignment because the two interventions differ in formulation and dosing. Investigators performing folliculometry and confirming ovulation, laboratory personnel processing progesterone and β-hCG assays, the adverse-event assessor, and the statistician are blinded to treatment assignment. Participants are instructed not to disclose their treatment regimen to outcome assessors.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* • Age between 20- 38 years old. * Diagnosis of PCOS according to Rotterdam criteria * Letrozole resistant cases. * Normal thyroid hormone level. * Normal prolactin hormone level.
Exclusion criteria
* • History of ovarian surgery. * cases associated with endometriosis. * History of diabetes mellitus. * Allergy to myo-Inositol .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative Ovulation rate over 3 cycles confirmed by folliculometry measured by transvaginal ultrasound | 5 months (8 weeks priming phase + 3 consecutive cycles of letrozole ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| * clinical pregnancy | 5 months ( 8weeks of priming phase + 3 consecutive cycles of letrozole ) | Percentage of participants who achieve a clinical pregnancy, defined as visualization of an intrauterine gestational sac with fetal cardiac activity by transvaginal ultrasound. |
Countries
Egypt
Outcome results
None listed