Micronutrient Supplementation in PCO-syndrome (NCT03306745) | Clinical Trial Compass
CompletedNot Applicable
Micronutrient Supplementation in PCO-syndrome
Austria60 participantsStarted 2017-06-02
Plain-language 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, multinutrient supplementation on the course of PCOS-specific parameters namely anti-Mullerian hormone (AMH), testosterone, and androstenedione. A total of 60 infertile women with PCOS, previously untreated, will be randomized to receive either a combined standardized multinutrient supplementation (containing folic acid, selenium, vitamin E, catechins, glycyrrhizin, coenzyme Q10 and omega-3-fatty acids; study group) or folic acid alone (control group) in a double-blinded, randomized manner. These study medications will be provided for 3 months and pre- to posttreatment levels of AMH, testosterone, and AMH will be analysed. The study will be performed at the Clinical Division of Gynecologic Endocrinology and Reproductive Medicine of the Medical University of Vienna.
Who can participate
Age range19 Years – 35 Years
SexFEMALE
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Inclusion criteria
✓. 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 criteria
✕. No informed consent.
✕. At least one partner is younger than 19 years or older than 35 years.
✕
What they're measuring
1
Anti-Mullerian Hormone (AMH)
Timeframe: Change from pre-treatment, baseline serum level to serum level at 3 months of treatment.
2
testosterone
Timeframe: Change from pre-treatment, baseline serum level to serum level at 3 months of treatment.
3
androstenedione
Timeframe: Change from pre-treatment, baseline serum level to serum level at 3 months of treatment.
. 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.