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Endometrial Thickness and Subendometrial Vascularity in Anovulatory Polycystic Ovarian Syndrome Patients Treated by Metformin

A

Ain Shams Maternity Hospital

Status and phase

Unknown
Phase 4

Conditions

Polycystic Ovary Syndrome
Anovulatory

Treatments

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT03486626
Ain ShamsMH

Details and patient eligibility

About

The participants will receive metformin 500mg 3times per day for 3months and one month is left for spontaneous pregnancy to occur or not (primary outcome ) and the investigators will check endometrial thickness and subendometerial vascularity as markers of endometrial receptivity before and after the treatment.

Enrollment

85 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • PCO syndrome patients have the following criteria:

Age of the patient between 20 - 40 years old. All subjects are not on a specific diet nor a certain program of physical exercise Complaining of infertility either primary or secondary due to PCOS.

N.B: The diagnosis of PCO syndrome was made according to the Androgen Excess and Polycystic Ovarian Syndrome Society: the presence of the following criteria have been required for the diagnosis of PCO syndrome:

Hyperandrogenism: Hirsutism and/or Hyperandrogenaemia Ovarian Dysfunction : Oligo-Anovulation and /or Polycystic ovaries Exclusion of other Androgen Excess or related disorders as :( deficient nonclassic adrenal hyperplasia, androgen-secreting neoplasms, androgenic/anabolic drug use or abuse, Cushing's syndrome, the Hyperandrogenic-Insulin Resistance-Acanthosis Nigricans syndrome, thyroid dysfunction, and hyperprolactinemia).

Exclusion criteria

  • Age below 20 or above 40. Women who intended to start a diet or a specific program of physical activity. Concurrent medical illness as cardiovascular, neoplastic and hepatic disorder. Pelvic pathology. Tubal, Uterine, Male factor of infertility. Endocrinological factors including: diabetes Mellitus,hypothyroidism, hyperprolactinaemia, Cushing's syndrome, and non- classical congenital adrenal hyperplasia.

Patients who are ovulatory during the ovarian cycle

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

85 participants in 1 patient group

Patients
Experimental group
Treatment:
Drug: Metformin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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