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| Name | Class |
|---|---|
| Maastricht University Medical Center | OTHER |
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In 50% of women with recurrent pregnancy loss (RPL) miscarriages are unexplained, therefore no therapeutic intervention is possible. In a pilot study, women with unexplained RPL showed less endometrial NK cells (eNK) compared to women with a previously uncomplicated pregnancy. It is known that eNK cells are important for embryo implantation during early pregnancy. Investigators presume that high sympathetic activity in these women is related to eNK cell number, function and phenotype and that exercise is an effective intervention to lower sympathetic activity and to influence the immune system, as especially peripheral NK cells have been assumed to be responsive to physical training. The investigators hypothesize that moderate exercise can lower the adrenergic tone of the sympathetic nervous system hereby influencing endometrial NK cells in women with RPL and eventually pregnancy outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| <80% eNK | Other | Women with low eNK bright cell numbers, defined as <80% of the total endometrial NK cell population |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Aerobe cycling training consisting of 12-weeks of HR-controlled training at 50-60% of VO2max (maximal oxygen uptake) for 1 hour, for 2 times (week: 1-6) to 3 times (week: 7-12) per week |
| Measure | Description | Time Frame |
|---|---|---|
| CD56 endometrial NK cell frequency | Change in CD56 eNK cell frequency measured as percentage of total lymphocyte or total CD56 population by flowcytometry. | 3 months |
| CD56 endometrial NK cell function | Change in CD56 eNK cell function measured as percentage of CD56 degranulation by flowcytometry. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| CD56 endometrial NK cell phenotype | Change in CD56 eNK cell phenotype measured as percentage of (sub)population or mean fluorescent intensity respectively by flowcytometry. | 3 months |
| CD56 peripheral NK cell frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tess Meuleman | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht UMC+ | Maastricht | 6202 AZ | Netherlands | |||
| Radboud UMC |
On reasonable special request only.
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Change in CD56 pNK cell frequency measured as percentage of total lymphocyte or CD56 population by flowcytometry.
| 3 months |
| CD56 peripheral NK cell function | Change in CD56 pNK cell function measured as percentage of CD56 degranulation by flowcytometry. | 3 months |
| CD56 peripheral NK cell phenotype | Change in CD56 pNK cell phenotype measured as percentage of (sub)population or mean fluorescent intensity respectively by flowcytometry. | 3 months |
| Vaginal microbiome | Change in taxonomic classification of vaginal microbiota of different subtypes but also classified in clustering of different subtypes. | 3 months |
| Metabolic syndrome parameters I | Change in cm waist circumference. | 3 months |
| Metabolic syndrome parameters II | Chance in mmHg blood pressure, both systolic as diastolic. | 3 months |
| Metabolic syndrome parameters III | Change in concentration (mg/dL) triglyceride. | 3 months |
| Metabolic syndrome parameters IV | Change in concentration (mg/dL) cholesterol levels. | 3 months |
| Metabolic syndrome parameters V | Change in concentration (mg/dL) blood sugar levels. | 3 months |
| Sympathetic activity | Change in baroreceptor sensitivity in ms/mmHg. | 3 months |
| Uterine blood flow | Change in pulsatility index, lower indicates better outcome. | 3 months |
| Physical fitness | Change in VO2max. | 3 months |
| Pregnancy rate and live birth rate after one year of intervention, higher rater indicate better outcome. | Questionnaire. | 3 months |
| Nijmegen |
| 6500 HB |
| Netherlands |