ClinConnect ClinConnect Logo
Search / Trial NCT00994812

The Effects of Metformin on Pregnancy and Miscarriage Rates in Polycystic Ovary Syndrome (PCOS)

Launched by UNIVERSITY OF OULU · Oct 13, 2009

Trial Information

Current as of May 05, 2025

Completed

Keywords

Polycystic Ovary Syndrome Pcos Metformin Miscarriage Infertility Complications Of Pregnancy

ClinConnect Summary

Women with PCOS represent about 5-10% of the general female population and one third of the women treated for infertility. Thus, the development of new therapies to improve the efficiency of ovulation induction treatments and the outcome of pregnancy, and to reduce the long-term risks of the syndrome would bring important health benefits.

The central role played by insulin resistance and hyperinsulinemia in PCOS - causing hyperandrogenism, premature follicular atresia, anovulation, oligo-amenorrhea and anovulatory infertility - has led to the use of insulin-lowering drugs for the treatment...

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. age \< 40 years at entry
  • 2. BMI \> 19 kg/m2
  • 3. Infertility lasting \> 1 year
  • 4. Criteria for PCOS are as defined by ESHRE/ASRM: at least two of the following findings:
  • polycystic ovaries shown by vaginal ultrasonography (more than 12 subcapsular follicles of 3-8 mm diameter in one plane of the ovary)
  • oligomenorrhea or amenorrhea
  • clinical manifestations of hyperandrogenism such as a hirsutism score of \> 7 according to Ferriman and Gallwey (Ferriman \& Gallwey 1961)and/or an elevated serum testosterone level (\> 2.7 nmol/l).
  • Exclusion Criteria:
  • 1. diabetic subjects
  • 2. alcohol users
  • 3. active liver disease (ALAT \> +2 SD the upper normal value i.e.\> 100IU/l)
  • 4. hormonal drugs
  • 5. past or present cardiac failure (NYHA I-IV)
  • 6. liver or renal failure (S-Creatinine above the normal value ie.124 umol/l)
  • 7. pregnancy or lactation
  • 8. hypersensitivity to metformin

About University Of Oulu

The University of Oulu, located in Finland, is a leading research institution known for its commitment to advancing scientific knowledge and innovation in various fields, including health sciences. As a clinical trial sponsor, the University of Oulu leverages its extensive academic expertise, state-of-the-art facilities, and collaborative networks to conduct rigorous and ethically sound clinical research. The university emphasizes interdisciplinary approaches and strives to translate research findings into practical applications that improve patient outcomes and contribute to public health. Through its clinical trials, the University of Oulu aims to foster advancements in medical science while adhering to the highest standards of integrity and compliance.

Locations

Helsinki, , Finland

Kuopio, , Finland

Oulu, , Finland

Tampere, , Finland

Turku, , Finland

Patients applied

0 patients applied

Trial Officials

Laure C Morin-Papunen, PhD

Principal Investigator

University hospital of Oulu

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials