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A comparative study of the effects of two drugs, atorvastatin and glucophage, on plasma insulin resistance and follicular fluid changes in women with polycystic ovary syndrome.

A comparative study of the effect of two drugs, atorvastatin and glucophage, on plasma insulin resistance and follicular fluid changes (the amount of antioxidants and oocyte growth factors) in women with polycystic ovary syndrome.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240122060763N1
Enrollment
50
Registered
2024-02-01
Start date
2024-02-22
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with polycystic ovary syndrome.

Interventions

Intervention 1: Intervention group: Using atorvastatin in the amount of 40 mg every night after dinner for 6 weeks until the day of egg retrieval. Intervention 2: Control group: Taking 500 mg Glucopha

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: According to the Rotterdam criteria (the presence of two criteria for the diagnosis of polycystic ovaries 1- oligomenorrhea or amenorrhea 2- clinical or laboratory findings of hyperandrogenism 3- the presence of polycystic ovaries in ultrasound examination) the diagnosis of PCOS has been confirmed in them Age 18-40 years Absence of thyroid disorder, Cushing's syndrome, hyperprolactinoma Absence of kidney disease, liver disease, diabetes, lipid profile disorder No history of cardiovascular disease and blood pressure Not using ovarian stimulation drugs or hormonal drugs in the last 3 months Not using insulin-sensitive drugs or lipid profiles in the last 3 months not smoking non-alcoholic No use of addictive substances Not having breast cancer Absence of medicinal contraindications Absence of malabsorption Having a minimally abnormal amount of insulin resistance

Exclusion criteria

Exclusion criteria: Body mass more than 30 kg/m2 Body mass less than 19 kg/m2

Design outcomes

Primary

MeasureTime frame
The amount of insulin resistance is measured based on the HOMA index. The amount of fasting insulin is multiplied by the amount of fasting sugar and the resulting number is divided by 22.5, which is equal to 1 in normal people. Timepoint: The amount of insulin resistance is measured once before the intervention in two groups and again after the intervention in two groups. Method of measurement: Measuring insulin resistance: the amount of fasting insulin is multiplied by the amount of fasting sugar and the resulting number is divided by 22.5, which is equal to 1 in normal people.

Secondary

MeasureTime frame
Changes of MDA (malon-di-aldehyde) in follicular fluid. Timepoint: After the intervention, it is measured in the follicular fluid and compared with the standard value. Method of measurement: Using a commercial measuring kit of malondialdehyde kiazist.;Examination of TAC (Total Antioxidant Capacity) in follicular fluid. Timepoint: After the intervention and comparison with the standard value. Method of measurement: Using a commercial kit to measure TAC is key.;Investigation of catalase changes in follicular fluid. Timepoint: After the intervention and comparison with the standard value. Method of measurement: Using the commercial kit for measuring catalase of Kiazist company.;Measuring changes in oocyte growth factor (GDF-9) in granulosa cells. Timepoint: After the intervention and comparison with the standard value. Method of measurement: Through the expression of the gene of this protein with the help of Realtime PCR.;Changes in oocyte growth factor (BMP15) in granulosa cells. Timepoint: After the intervention and comparison with the standard value. Method of measurement: Through gene expression and Realtime PCR.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSanaz Alaee

Shiraz University of Medical Sciences

alaee@sums.ac.ir+98 71 3725 5699

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026