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Completed

NCT Number: NCT02568488

The Effect of Metformin on Different Hormones in PCOS Patients

Forty eight PCOS patients were included . The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:

1. history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles per year or amenorrhoea (cycle length > 12wks), 2. infertility with hirsutism or acne or elevation of one or more of serum androgen levels 3. ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2-10mm).

the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months. Blood samples were collected at the start of the study, before receiving metformin, where baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) , total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and 6 months respectively of metformin treatment , to asses its effect on serum levels of the previously mentioned hormonal parameters.

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Key information

About this study

Forty eight PCOS patients attending the OBGYN clinic at kasr al aini were included in the study. The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:

  • history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles per year or amenorrhoea (cycle length > 12wks),
  • infertility with hirsutism or acne or elevation of one or more of serum androgen levels
  • ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2-10mm).

the studied subjects were to receive metformin 850 mg twice daily over a period of 6 months. Blood samples were collected at the start of the study, before receiving metformin, where baseline serum insulin (fasting and 2 hr postprandial), sex hormone binding globulin (SHBG) , total and free testosterone, Dihydroepiandrostenedione sulphate (DHEAS) and Antimullerian Hormone (AMH) were obtained before starting metformin. Blood samples were collected at 3 and 6 months respectively of metformin treatment , to asses its effect on serum levels of the previously mentioned hormonal parameters.

The effect of metformin on PCOS patients regarding its clinical and radiological parameters was also assessed. Each patient was asked to keep a diary of her menstrual periods over the study period; to elicit if there could be an effect by metformin on the regulation of menstrual cycles secondary to improvement of ovarian function as a result of improving insulin resistance in such patients. The effect of metformin on ovarian morphology by ultrasound was also assessed at baseline, 3months and 6 months of the study period; ovarian volume and number of follicles was noted down at each visit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non pregnant PCOS patients .
  • The diagnosis of PCOS was made based on the three criteria set by the Rotterdam Consensus meeting definition of PCOS (ESHRE, ASRM, 2004). The criteria were as follows:
  • history of chronic anovulation defined as cycle length > 35 days, or less than 9 cycles per year or amenorrhoea (cycle length > 12wks),
  • infertility with hirsutism or acne or elevation of one or more of serum androgen levels
  • ultrasonographic findings of polycystic ovaries ( increased ovarian volume, more than eight follicles in an ovary ranging from 2-10mm).

Exclusion criteria

  • those with prior history of glucose intolerance,
  • history of gestational diabetes,
  • NIDDM patients,
  • cushing's syndrome,
  • thyroid dysfunction,
  • hyperprolactinemia,
  • congenital adrenal hyperplasia
  • patients on prolonged corticosteroid course, or other medications that alter the hormonal or metabolic profile; including PCOS patients who were on OCPs or cyclic progestagens

Treatment and study plan

metformin

Drug

850 mg orally twice daily for 6 months

Other names: glucophage

Primary outcomes

  1. hormonal changes

    Time frame: Change from Baseline at 3 and 6 months

    total and free testosterone

Secondary outcomes

  1. serum insulin levels

    Time frame: Change from Baseline at 3 and 6 months

    serum insulin (fasting and 2 hr postprandial)

  2. ovarian morphology

    Time frame: Change from Baseline at 3 and 6 months

    ovarian volume and number of follicles

  3. sex hormone binding globulin (SHBG)

    Time frame: Change from Baseline at 3 and 6 months

  4. Antimullerian Hormone (AMH)

    Time frame: Change from Baseline at 3 and 6 months

  5. Dihydroepiandrostenedione sulphate (DHEAS)

    Time frame: Change from Baseline at 3 and 6 months

Sponsors and collaborators

Lead sponsor

Ahmed Maged

Other

Registry information

Official study title

The Effect of Metformin on Serum Insulin, Androgens and AMH in PCOS Patients

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 6, 2015
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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