Female Subfertility: a Metabolic and Vascular Profile

NCT02136472 | Unknown DMC

• 1 other identifier: METC 13-2-001
• Study Type: observational
• Target: 512
• Locations: 1 country
• Sites: 1

Brief 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:

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

Conditions

Metabolic Syndrome X; Infertility

Keywords

Subfertility; Metabolic syndrome; Plasma volume; Intima media thickness; Flow mediated dilatation

Outcome Measures

Primary Outcomes (2)

• The prevalence of the metabolic syndrome in subfertile women

  Subfertility is defined as trying to conceive for at least one year but did not lead to a pregnancy.

  Within 3 months of start of a basic fertility work-up

• The cardiovascular profile in subfertile women with an unexplained subfertility or a decreased ovarian reserve

  The cardiovascular profile consists of the plasma volume as measure of venous reserve, the uterine artery pulsatility index as measure of uterine perfusion, the intima media thickness as proxy of chronic strain and the endothelial function of the vascular system.

  Within 3 months after completing the basic fertility work-up

Study Arms (1)

Subfertile women

Women who visit the fertility clinic of the Maastricht University Medical Centre who start with a basic fertility work-up. Women diagnosed with an unexplained subfertility or with (signs of) a decreased ovarian reserve are asked for further participation in the study of the cardiovascular profile. As a control group parous women with an uncomplicated pregnancy more than 6 months ago will be asked for participation.

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Study 1: * Study group: subfertile women between 18 and 41 years who visit our fertility clinic in the Maastricht University Medical Centre with a primary or secondary subfertility, independent of the cause of their subfertility * Control group: women with a history of an uneventful spontaneous pregnancy Study 2: Women who finished the basic fertility work up and are diagnosed with: * an unexplained subfertility: study group 1 * an "expected" decreased ovarian reserve: study group 2 Control group: women with a history of an uneventful spontaneous pregnancy Study 3: Women who received an IVF treatment in the period of 2010 - 2012 and: * study group: had a "proven" decreased ovarian response, defined as retrieving 3 oocytes or less at an ovum pick-up, despite maximal ovarian stimulation * control group: received and IVF/ICSI treatment because of a severe male subfertility

You may qualify if:

• Study 1
• Study group:
• primary subfertility, defined as having no previous pregnancy, or secondary subfertility, defined as a fertility problem after an ongoing pregnancy
• age 18 - 41 years
• Control group:
• women with an uneventful pregnancy in history
• at least 6 months post partum
• age 18 - 41 years
• Study 2
• Study groups:
• primary subfertility, defined as having no previous pregnancy, or secondary subfertility, defined as a fertility problem after an ongoing pregnancy
• age 18 - 41 years
• participation in study 1
• no abnormalities in the basic fertility work up ("unexplained subfertility"); study group 1, or "expected" decreased ovarian reserve (Follicle Stimulating Hormone (FSH) \> 8 u/l); study group 2
• Control group:

You may not qualify if:

• Study 1
• current pregnancy
• hormonal medication
• breastfeeding
• Study 2
• hypertension, defined as a blood pressure exceeding 140 mm Hg systolic or 90 mm Hg diastolic, or the use of antihypertensive medication
• diabetes mellitus, defined as a fasting glucose level above 6,1 mmol/L or the use of antidiabetic medication
• hormonal medication
• current pregnancy
• breastfeeding
• Study 3
• extirpation of an ovary
• cystectomy

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, 6229 HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Infertility

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Ron JT van Golde, MD, PhD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

• Marc E Spaanderman, Prof

  Maastricht University Medical Centre

  STUDY DIRECTOR

Central Study Contacts

Desiree APM Pattinaja, Doctor of medicine

CONTACT

+31433876543; desiree.pattinaja@mumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD candidate

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 13, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

NL (1)