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Female subfertility: a first sign of metabolic and cardiovascular anomalies?

Recruiting
Conditions
metabool syndroom, veneuze reservacapaciteit, endotheelfunctie
subfertility
infertility
10013356
Registration Number
NL-OMON43743
Lead Sponsor
Medisch Universitair Ziekenhuis Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
516
Inclusion Criteria

Study 1*The metabolic syndrome and female subfertility* :
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 *The cardiovascular profile in female subfertility*:
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*); studygroup 1, or *expected* decreased ovarian reserve (Follicle Stimulating Hormone (FSH) > 8 u/l); studygroup 2
Control group:
- women with an uneventful pregnancy in history
- at least 6 months post partum
- age 18 * 41 years;Study 3 *The cardiovascular profile in women with a poor ovarian response* :
Study group:
- primary or secondary subfertility
- age 18 * 40 years
- IVF / ICSI treatment in the period from 2010 - 2013
- proven decreased ovarian response (* 3 oocytes at an ovum-pick up)
- maximal stimulation dosage of 250 IU FSH per day
Control group:
- primary or secondary subfertility
- age 18 * 40 years
- IVF / ICSI treatment in the period from 2010 - 2013
- severe male factor (TMC < 3 million spermatozoa)
- retrieved * 4 oocytes at an ovum-pick up
- normal stimulation dosage of 150 IU FSH per day

Exclusion Criteria

Study 1 *The metabolic syndrome and female subfertility*
There are no exclusion criteria for the study of the metabolic syndrome in the subfertile women.
For the control group exclusion criteria are:
- current pregnancy
- hormonal medication
- breastfeeding;Study 2 *The cardiovascular profile in female subfertility*
For the studies of the measurement of the uterine artery PI, plasma volume, intima media thickness and endothelial function exclusion criteria in all women are:
- 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
Additional exclusion criteria for the control group:
- hormonal medication
- current pregnancy
- breastfeeding;Study 3 *The cardiovascular profile in women with a poor ovarian response*
For the study group as well as the control group exclusion criteria are:
- extirpation of an ovary
- cystectomie
Both exclusion criteria can be a reason for a decreased ovarian response.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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