Micronutrient Supplementation in PCO-syndrome

NCT03306745 | Completed

• 1 other identifier: 1232/2016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Infertility, Female; Micronutrient Deficiency

Keywords

Polycystic Ovary Syndrome; Anti-Mullerian Hormone; Androgens; Micronutrient Supplementation

Outcome Measures

Primary Outcomes (3)

• Anti-Mullerian Hormone (AMH)

  Change in serum AMH level

  Change from pre-treatment, baseline serum level to serum level at 3 months of treatment.

• testosterone

  Change in serum testosterone level

  Change from pre-treatment, baseline serum level to serum level at 3 months of treatment.

• androstenedione

  Change in serum androstenedione level

  Change from pre-treatment, baseline serum level to serum level at 3 months of treatment.

Study Arms (2)

Study group

EXPERIMENTAL

* 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

Control group

PLACEBO COMPARATOR

200µg folic acid - two capsules per day

Dietary Supplement: Folic acid 400 mg

Interventions

Profertil female DIETARY_SUPPLEMENT

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".

Study group

Folic acid 400 mg DIETARY_SUPPLEMENT

Folic acid 400 mg

Control group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Clinical Division of Gynecologic Endocrinology and Reproductive Medicine

Vienna, 1090, Austria

Location

Related Publications (1)

• Hager M, Nouri K, Imhof M, Egarter C, Ott J. The impact of a standardized micronutrient supplementation on PCOS-typical parameters: a randomized controlled trial. Arch Gynecol Obstet. 2019 Aug;300(2):455-460. doi: 10.1007/s00404-019-05194-w. Epub 2019 May 17.

  PMID: 31101977 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility, Female

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Infertility

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.-Prof. Priv.-Doz. Dr.

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: October 11, 2017
• Study Start: June 2, 2017
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)