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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Helsinki, , Finland
Kuopio, , Finland
Oulu, , Finland
Tampere, , Finland
Turku, , Finland
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
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