Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43743
Enrollment
516
Registered
2013-10-16
Start date
2014-04-16
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabool syndroom, veneuze reservacapaciteit, endotheelfunctie infertility subfertility

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Study 1: Prevalence of metabolic syndrome in subfertile women compared to fertile controls. Study 2:The cardiovascular profile, in women with an unexplained subfertility or an *expected* decreased ovarian reserve, consisting of: 1. The uterine artery pulsatility index as measure for uterine perfusion 2. The plasma volume as measure for venous reserve capacity 3. The intima media thickness (IMT) of the carotid arteries as proxy for chronic strain 4. The endothelial function of the vascular system (FMD) Study 3: The cardiovascular profile, in women with a poor ovarian response, consisting of: 1. The uterine artery pulsatility index as measure for uterine perfusion 2. The plasma volume as measure for venous reserve capacity 3. The intima media thickness (IMT) of the carotid arteries as proxy for chronic strain 4. The endothelial function of the vascular system (FMD)

Secondary

MeasureTime frame
not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)