Status:
COMPLETED
Micronutrient Supplementation in PCO-syndrome
Lead Sponsor:
Medical University of Vienna
Conditions:
Polycystic Ovary Syndrome
Infertility, Female
Eligibility:
FEMALE
19-35 years
Phase:
NA
Brief Summary
The role of micronutrients in fertility has recently gained increased attention. In women who suffer from polycystic ovary syndrome (PCOS) and infertility, we aim to test the impact of a standardized,...
Detailed Description
Introduction and scientific background: In the Western world, malnutrition and subfertility have become increasingly common problems affecting both men and women. A recent study showed that conformin...
Eligibility Criteria
Inclusion
- The patient has been diagnosed with PCO-syndrome using revised 2004 Rotterdam-criteria (7).
- The patient is sterile, defined as being unable to become pregnant within a year despite unprotected sexual intercourse.
- The patient suffers either from oligomenorrhoea (defined as an interval of ≥60 days between the last three menstruations) or complete amenorrhoea for at least 90 days.
- The patient has given her written informed consent after detailed information on the study by medical professionals at the Department of Obstetrics and Gynecology of the Medical University of Vienna.
- Both partners are at least 19 years old and are younger than 35. The age limit was chosen to take physiologically reduced fertility beyond this age (8). This measure allowed the women to avoid a 100-day delay of fertility treatments due to this study.
Exclusion
- No informed consent.
- At least one partner is younger than 19 years or older than 35 years.
- The patient has been subject to one of the following PCO-syndrome-related treatments within three months before inclusion: metformin, combined oral contraceptives, cortisol therapy, inositol, ovarian drilling, any kind of ovarian stimulation, in-vitro fertilisation. Promoting menstruation using gestagen products is acceptable.
Key Trial Info
Start Date :
June 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03306745
Start Date
June 2 2017
End Date
June 25 2018
Last Update
September 6 2018
Active Locations (1)
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1
Medical University of Vienna, Clinical Division of Gynecologic Endocrinology and Reproductive Medicine
Vienna, Austria, 1090