Polycystic Ovary Syndrome Clinical Trial
Official title:
Is the Co-administration of Metformine and CC as Compared to Placebo and CC Superior to Induce Ovulation in PCOS Patients With a Confirmed insulin-resistant-a Double Blind Randomized Clinical Trial
Verified date | April 2024 |
Source | Semnan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility which affects 12-21% of the population.Several studies performed evaluate the possible benefit of metformin alone or in combination with clomiphene (CC)as first-line treatment for infertility in women with PCOS have reported conflicting results. These conflicting results may be due to the presence or absence of insulin resistance(IR).Metformin decreases IR .However there is not a single randomized clinical trial with metformin in IR PCOS patients. Therefore, the aim of current study is to compare CC with coadministration of metformin and with CC with coadministration of placebo in IR PCOS patients to induce ovulation.
Status | Terminated |
Enrollment | 388 |
Est. completion date | April 2022 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 36 Years |
Eligibility | Inclusion Criteria: - Insulin resistant ( HOMA-IR=2.3) PCOS women between 20-36 years of age, with period of infertility more than 1 year and normal serum prolactin ,normal TSH after treatment , normal hystero salpingography and had no other infertility factor. The diagnosis of PCOS according to the Rotterdam Criteria. Exclusion Criteria: - Diabetic women - Any medication that could influence carbohydrate metabolism or pituitary-gonadal function at least 2 months before the study - Hypertension or abnormal renal or liver function tests - Ovarian drilling. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Semnan University of Medical Sciences |
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* Note: There are 45 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ovulation rate | The progesterone levels will be measured every other week in order to document ovulation. A progesterone level > 5 ng/ml (16 nmol per liter) will considered as confirmatory of ovulation during metformine administration .Ovarian follicular response will be monitored by transvaginal sonography every other day from day 10 of the cycle to the 16th day of the cycle.ovulation will be confrmed When at least one follicle reached =18 mm in diameter. | every other weeks up to 8 weeks | |
Secondary | Clinical pregnancy rate | Clinical pregnancy will be defined as the detection of at least one gestational sac on transvaginal ultrasound examination starting one week after the missed period | 5 weeks of gestation | |
Secondary | Ongoing pregnancy rate | Ongoing pregnancy will be defined as the detection of an alive fetus>12weeks of gestation on transvaginal ultrasound examination. | 12 weeks of gestation |
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