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Micronutrient Supplementation in PCO-syndrome

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ClinicalTrials.gov Identifier: NCT03306745
Recruitment Status : Completed
First Posted : October 11, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Johannes Ott, Medical University of Vienna

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, 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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Infertility, Female Micronutrient Deficiency Dietary Supplement: Profertil female Dietary Supplement: Folic acid 400 mg Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The medications are unlabeled for both groups and will be dispensed in unlabeled blisteres. However, patients could search for the actual look of the PROfertil ® female soft capsules and the pills (for example on the internet). Since they differ from the folic acid capsules, patients could identify the control medications. We are aware of the fact that this kind of blinding is not according to standards and could introduce some kind of bias.
Primary Purpose: Treatment
Official Title: Micronutrient Supplementation for Women With PCO-syndrome - Influence of Nutrition and Physiology on the Development of PCOS-typical Parameters
Actual Study Start Date : June 2, 2017
Actual Primary Completion Date : June 25, 2018
Actual Study Completion Date : June 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group
  • 1 soft capsule/day containing 500mg omega-3 fatty acids
  • one tablet/day containing 800mg folic acid, 70mg selenium, 30 mg Vitamin E, 4 mg catechin, 12 mg glycyrrhizin, and 30 mg coenzyme Q10
Dietary Supplement: Profertil female
For micronutrient ingredients please see details above. PROfertil ® female is approved in Austria by the Austrian Ministry of Health and has a "Free Sales Certificate".

Placebo Comparator: Control group
200µg folic acid - two capsules per day
Dietary Supplement: Folic acid 400 mg
Folic acid 400 mg




Primary Outcome Measures :
  1. Anti-Mullerian Hormone (AMH) [ Time Frame: Change from pre-treatment, baseline serum level to serum level at 3 months of treatment. ]
    Change in serum AMH level

  2. testosterone [ Time Frame: Change from pre-treatment, baseline serum level to serum level at 3 months of treatment. ]
    Change in serum testosterone level

  3. androstenedione [ Time Frame: Change from pre-treatment, baseline serum level to serum level at 3 months of treatment. ]
    Change in serum androstenedione level



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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient has been diagnosed with PCO-syndrome using revised 2004 Rotterdam-criteria (7).
  2. The patient is sterile, defined as being unable to become pregnant within a year despite unprotected sexual intercourse.
  3. 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.
  4. 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.
  5. 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:

  1. No informed consent.
  2. At least one partner is younger than 19 years or older than 35 years.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306745


Locations
Austria
Medical University of Vienna, Clinical Division of Gynecologic Endocrinology and Reproductive Medicine
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  Study Documents (Full-Text)

Documents provided by Johannes Ott, Medical University of Vienna:
Study Protocol  [PDF] November 16, 2017
Statistical Analysis Plan  [PDF] November 16, 2017


Responsible Party: Johannes Ott, Assoc.-Prof. Priv.-Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03306745     History of Changes
Other Study ID Numbers: 1232/2016
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johannes Ott, Medical University of Vienna:
Polycystic Ovary Syndrome
Anti-Mullerian Hormone
Androgens
Micronutrient Supplementation

Additional relevant MeSH terms:
Syndrome
Infertility
Polycystic Ovary Syndrome
Infertility, Female
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Folic Acid
Vitamin B Complex
Micronutrients
Trace Elements
Hematinics
Vitamins
Growth Substances
Physiological Effects of Drugs