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The effect of alpha lipoic acid administration on the outcomes of assisted reproductive therapy in patients with polycystic ovarian syndrome

Phase 3
Conditions
polycystic ovarian syndrome
E28.2
Poly cystic ovarian syndrome.
Registration Number
IRCT20200905048630N4
Lead Sponsor
Bandare-abbas University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Female
Target Recruitment
40
Inclusion Criteria

Women with polycystic ovary syndrome according to the Rotterdam criteria
Women of reproductive age between 18 and 37 years
Candidate for in vitro fertilization
No endometriosis
Absence of hydrosalpinx

Exclusion Criteria

BMI=30
Secondary causes of obesity (hypothyroidism, Cushing's syndrome)
High grade endometriosis III and IV
Thyroid diseases
Salpingitis and hydrosalpinx
Congenital adrenal hyperplasia
Hyperprolactinemia
Ovarian secretory tumors
Receipt of OCPs (steroids or other drugs that affect ovarian function, insulin sensitivity, and lipid metabolism) in the past 3 months, except for standardized PCOS treatment
Lupus and autoimmune diseases
Systemic diseases such as hyperlipidemia and cardiovascular metabolic syndrome
Severe male factor, especially non-obstructive azoospermia (sperm count less than 5 million/ml)
Receive insulin

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The number of oocyte obtained. Timepoint: Two months after the start of the intervention. Method of measurement: Count the number.;The number of MII oocyte obtained. Timepoint: Two months after the start of the intervention. Method of measurement: Count the number.;Fertilization rate. Timepoint: Two months after the start of the intervention. Method of measurement: Count the number of formed zygote.
Secondary Outcome Measures
NameTimeMethod
Biochemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: Measurement of beta hormone serum level.;Clinical pregnancy. Timepoint: 6 weeks after embryo transfer. Method of measurement: Sonography.
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