Metabolic Syndrome XNCT02136472
Female Subfertility: a Metabolic and Vascular Profile
An observational study of Metabolic Syndrome X and Infertility, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X, Infertility
- How many people
- 512 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
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- 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:
- women with an uneventful pregnancy in history
- at least 6 months post partum
- age 18 - 41 years
- Study 3
- Study group:
- primary subfertility, defined as having no previous pregnancy, or secondary subfertility, defined as a fertility problem after an ongoing pregnancy
- age 18 - 40 years
- IVF / ICSI treatment in the period from 2010 - 2012
- 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 - 2012
- severe male factor (TMC < 3 million spermatozoa)
- retrieved ≥ 4 oocytes at an ovum-pick up
- normal stimulation dosage of 150 IU FSH per day
Who cannot join
- Study 1
- There are no exclusion criteria for the study of the metabolic syndrome in the subfertile study group.
- For the control group exclusion criteria are:
- current pregnancy
- hormonal medication
- breastfeeding
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- Study 2
- 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
- For the study group as well as the control group exclusion criteria are:
- extirpation of an ovary
- cystectomy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Centre
Maastricht, 6229 HX
Desiree APM Pattinaja, +31433876543 ext. 66370, desiree.pattinaja@mumc.nl
Desiree Pattinaja, PhD candidate, MD
About this study
Official title: Female Subfertility: a First Sign of Metabolic and Cardiovascular Anomalies?
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.
Read more
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:
- Prevalence of metabolic syndrome in subfertile women
- 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)
Read the detailed description
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. A basic fertility work-up focuses on the reproductive system of the couple. After this basic fertility work-up the subfertility remains unexplained in 16-24% of the couples. 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. For all possible assessed abnormalities, proven effective treatments are available such as primarily life style corrective actions. Furthermore these interventions could lead to better results in fertility treatment, better obstetric outcome and reduced lifelong health risks.
Objective:
The overall objective of this study is to examine specific cardio-metabolic and cardiovascular parameters in women of subfertile couples. This study protocol is divided into 3 studies to evaluate several cardio-metabolic/cardiovascular parameters in different subgroups of female subfertility compared to fertile women.
- Study 1 "The metabolic syndrome and female subfertility": The prevalence of metabolic syndrome in all women who are assessed for subfertility compared to fertile women.
- Study 2 "The cardiovascular profile in female subfertility": The cardiovascular profile of women with female subfertility classified as unexplained subfertility or "expected" decreased ovarian reserve compared to fertile women. For this study 4 measurements will be performed: 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 3 "The cardiovascular profile of women with a poor ovarian response": The cardiovascular profile of women who had an In Vitro Fertilisation (IVF) population with a "proven" decreased ovarian reserve
With these different studies, the investigators hope to identify possible cardio-metabolic/cardiovascular causes for female subfertility. This can lead to new treatment options for female subfertility, enhancing reproductive and obstetric outcome, and a risk assessment for later in life.
Study design:
We want to perform cross-sectional studies.
Study population:
Study 1:
- Study group: subfertile women between 18 and 41 years who visit the 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/Intracytoplasmic Sperm Injection (ICSI) treatment because of a severe male subfertility
Main study parameters:
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:
- The uterine artery pulsatility index as measure for uterine perfusion
- The plasma volume as measure for venous reserve capacity
- The intima media thickness (IMT) of the carotid arteries as proxy for chronic strain
- The endothelial function of the vascular system (FMD)
Study 3: The cardiovascular profile, in women with a poor ovarian response, consisting of:
- The uterine artery pulsatility index as measure for uterine perfusion
- The plasma volume as measure for venous reserve capacity
- The intima media thickness (IMT) of the carotid arteries as proxy for chronic strain
- 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
- Medical subject headings
- Metabolic Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 3 months after completing the basic fertility work-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 512 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Desiree Pattinaja, Maastricht University Medical Center
- Investigators
- Ron JT van Golde, MD, PhD, Principal investigator, Maastricht University Medical CentreMarc E Spaanderman, Prof, Study director, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136472
- Sponsor's protocol ID
- METC 13-2-001
- Status last verified
- Jan 2016
- First submitted
- 30 Apr 2014
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Subfertility: a First Sign of Metabolic and Cardiovascular Anomalies?
- ClinicalTrials.gov ID
- NCT02136472
- Acronym / sponsor ID
- METC 13-2-001
- Conditions
- Metabolic Syndrome X, Infertility
- Keywords
- Subfertility, Metabolic syndrome, Plasma volume, Intima media thickness, Flow mediated dilatation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 512 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Prevalence of metabolic syndrome in subfertile women
- 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)
Detailed description
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. A basic fertility work-up focuses on the reproductive system of the couple. After this basic fertility work-up the subfertility remains unexplained in 16-24% of the couples. 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. For all possible assessed abnormalities, proven effective treatments are available such as primarily life style corrective actions. Furthermore these interventions could lead to better results in fertility treatment, better obstetric outcome and reduced lifelong health risks.
Objective:
The overall objective of this study is to examine specific cardio-metabolic and cardiovascular parameters in women of subfertile couples. This study protocol is divided into 3 studies to evaluate several cardio-metabolic/cardiovascular parameters in different subgroups of female subfertility compared to fertile women.
- Study 1 "The metabolic syndrome and female subfertility": The prevalence of metabolic syndrome in all women who are assessed for subfertility compared to fertile women.
- Study 2 "The cardiovascular profile in female subfertility": The cardiovascular profile of women with female subfertility classified as unexplained subfertility or "expected" decreased ovarian reserve compared to fertile women. For this study 4 measurements will be performed: 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 3 "The cardiovascular profile of women with a poor ovarian response": The cardiovascular profile of women who had an In Vitro Fertilisation (IVF) population with a "proven" decreased ovarian reserve
With these different studies, the investigators hope to identify possible cardio-metabolic/cardiovascular causes for female subfertility. This can lead to new treatment options for female subfertility, enhancing reproductive and obstetric outcome, and a risk assessment for later in life.
Study design:
We want to perform cross-sectional studies.
Study population:
Study 1:
- Study group: subfertile women between 18 and 41 years who visit the 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/Intracytoplasmic Sperm Injection (ICSI) treatment because of a severe male subfertility
Main study parameters:
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:
- The uterine artery pulsatility index as measure for uterine perfusion
- The plasma volume as measure for venous reserve capacity
- The intima media thickness (IMT) of the carotid arteries as proxy for chronic strain
- The endothelial function of the vascular system (FMD)
Study 3: The cardiovascular profile, in women with a poor ovarian response, consisting of:
- The uterine artery pulsatility index as measure for uterine perfusion
- The plasma volume as measure for venous reserve capacity
- The intima media thickness (IMT) of the carotid arteries as proxy for chronic strain
- The endothelial function of the vascular system (FMD)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (32 listed)
- Study 1
- Study group:
- Control group:
- Study 2
- Study groups:
Key exclusion criteria (18 listed)
- Study 1
- There are no exclusion criteria for the study of the metabolic syndrome in the subfertile study group.
- For the control group exclusion criteria are:
- Study 2
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of the metabolic syndrome in subfertile women
Time frame: Within 3 months of start of a basic fertility work-up
Subfertility is defined as trying to conceive for at least one year but did not lead to a pregnancy.
The cardiovascular profile in subfertile women with an unexplained subfertility or a decreased ovarian reserve
Time frame: Within 3 months after completing the basic fertility work-up
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron JT van Golde, MD, PhD principal investigator
Maastricht University Medical Centre
Marc E Spaanderman, Prof study director
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome X and Infertility, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Desiree APM Pattinaja, Doctor of medicine (+31433876543 ext. 66370, desiree.pattinaja@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of the metabolic syndrome in subfertile women (time frame: Within 3 months of start of a basic fertility work-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.