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Female Subfertility: a Metabolic and Vascular Profile

NCT02136472 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 512

Last updated 2016-01-07

No results posted yet for this study

Summary

Introduction:

Overall, 10 - 15% of couples seek specialist help once in their lives when a spontaneous pregnancy does not occur. These couples are defined subfertile when there is at least one year of unprotected intercourse without conceiving. Subfertility can have different causes which can be diagnosed with a basic fertility work-up. Unfortunately, the subfertility in 25% of the couples still remains unexplained.

Hypothesis:

The investigators hypothesize that cardio-metabolic and hemodynamic abnormalities reducing cardiovascular reserves relate to circulatory redistribution at the expense of uterine perfusion and with it women's fertility. This could especially be important in the subgroups with an unexplained subfertility and a decreased ovarian reserve. Interventions to improve these abnormalities could lead to better results in fertility treatment, better obstetric outcome and reduced lifelong health risks.

Objective:

The investigators want to examine specific cardio-metabolic and cardiovascular parameters in women of subfertile couples. The investigators want to evaluate the prevalence of metabolic syndrome in all women who are assessed for subfertility compared to healthy parous women. Furthermore in the women with an unexplained subfertility or with (signs of) a decreased ovarian reserve the cardiovascular profile will be studied consisting of the uterine artery pulsatility index (PI) as measure of uterine perfusion, the plasma volume as measure of venous reserve capacity, the intima media thickness of the carotid arteries as proxy of chronic strain and the endothelial function, measured by flow mediated dilatation (FMD) of the brachial artery.

Study design:

Cross-sectional

Study population:

The study group consists of subfertile women between 18 and 41 years who visit the fertility clinic in the Maastricht University Medical Centre with a primary or secondary subfertility. Women with an unexplained subfertility or with (signs of) a decreased ovarian reserve are evaluated for their cardiovascular profile. The control group consists of women with a history of an uneventful spontaneous pregnancy.

Main study parameters:

1. Prevalence of metabolic syndrome in subfertile women
2. The cardiovascular profile, in women with an unexplained subfertility or with (signs of) a decreased ovarian reserve, consisting of:

* The uterine artery pulsatility index
* The plasma volume
* The intima media thickness (IMT)
* The endothelial function of the vascular system (FMD)

Conditions

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Ron JT van Golde, MD, PhD · Maastricht University Medical Centre

  • Marc E Spaanderman, Prof · Maastricht University Medical Centre

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02136472 on ClinicalTrials.gov