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临床试验/NCT03306745
NCT03306745已完成不适用

Micronutrient Supplementation for Women With PCO-syndrome - Influence of Nutrition and Physiology on the Development of PCOS-typical Parameters

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Anti-Mullerian Hormone (AMH)

研究概览

简要总结

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.

详细描述

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 conforming to nutritional recommendations significantly increased the probability of a clinical pregnancy following vitro fertilisation (IVF)/ intracytoplasmatic sperm injection (ICSI). They included fruit, vegetables, certain types of meat, fish, whole-grain products and specific fats (according to the Netherlands Nutrition Centre Foundation). Another study specifically analysed preconceptional consumption of unsaturated fatty acids by women before IVF/ICSI. It discovered a positive effect on the embryo's morphology.

The effect of micronutrients on female fertility is currently under investigation. A 2012 review on the subject included 13 studies with more than 90,000 female participants and provided no generalised recommendations, but allowed the authors to deduce a certain positive effect of supplementation with certain micronutrients on female fertility.

This current study will test the effect of a currently available micronutrient supplementation in women suffering from polycystic ovary (PCO)-syndrome and sterility. The product (PROfertil ® female, Lenus Pharma, Seeböckgasse 59, 1160 Vienna, Austria) is based on several studies that showed (i) an increased need for these micronutrients of women with a desire to have a child or currently pregnant and/or (ii) a positive effect on female fertility. PROfertil ® female is a micronutrient supplement containing selenium, vitamin E, catechins, glycyrrhizin, co-enzyme Q10, folic acid and omega-3 fatty acids.

This study seems of impact from a scientific perspective. Clinical experience with PROfertil ® female suggests that patients suffering from PCO-syndrome experience an increase of anti-müllerian hormone and androgen levels. The reductive effect of PCO-typical serum parameters can be explained pathophysiologically: A chronic low-level pro-inflammatory state - both locally in the ovary and systemically - appears to be among the central pathophysiological correlates of PCO-syndrome. PROfertil ® female contains a mix of several antioxidative agents. A favourable effect on PCO-syndrome is expected. Metformin is an anti-inflammatory substance commonly used to treat PCO-syndrome. The anti-inflammatory effect is seen as positive. This explains why women suffering from PCO-syndrome without insulin-glucose balance problems react positively to treatment with metformin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

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.

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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
  • 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.

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: Profertil female (Dietary Supplement)

Control group

Placebo Comparator

200µg folic acid - two capsules per day

干预措施: Folic acid 400 mg (Dietary Supplement)

结局指标

主要结局

Anti-Mullerian Hormone (AMH)

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

Change in serum AMH level

androstenedione

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

Change in serum androstenedione level

testosterone

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

Change in serum testosterone level

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Johannes Ott

Assoc.-Prof. Priv.-Doz. Dr.

Medical University of Vienna

研究点 (2)

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