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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06007560
Other study ID # HMOVE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 21, 2022
Est. completion date August 2024

Study information

Verified date August 2023
Source Radboud University Medical Center
Contact Tess Meuleman, Dr. MD.
Phone 0031-631133392
Email tess.meuleman@radboudumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender Female
Age group N/A to 40 Years
Eligibility Inclusion Criteria: - RPL defined as 2 or more unexplained pregnancy losses from the time of conception until 24 weeks of gestation, known cause for the miscarriages are the presence of thyroid abnormalities, anti-phospholipid syndrome, uterine malformation, and abnormal parental karyotype according to international guideline. - Couples should not be aiming to conceive during the time course of the exercise intervention. Exclusion Criteria: - Age above 40 years - BMI above 40 - Current use of immunosuppressive or biological drugs - Current use of hormone conceptive - HIV positivity - Current or recent (<2 weeks) symptomatic genital infection such as chlamydia, gonorroa, or pelvic inflammatory disease - Pre-existent diabetes mellitus, autoimmune disease or overt cardiovascular disease - Vaccination (i.e Covid) within 1 month prior to or during sampling and intervention - New pregnancy at time of measurements, breastfeeding - Current or recent (<2-3 months ago) pregnancy - (Physical) inabilities to follow moderate aerobe cycling training - Participants who are not capable of signing the informed consent

Study Design


Intervention

Other:
Exercise
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

Locations

Country Name City State
Netherlands Maastricht UMC+ Maastricht
Netherlands Radboud UMC Nijmegen

Sponsors (2)

Lead Sponsor Collaborator
Radboud University Medical Center Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary CD56 endometrial NK cell function Change in CD56 eNK cell function measured as percentage of CD56 degranulation by flowcytometry. 3 months
Secondary 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
Secondary CD56 peripheral NK cell frequency Change in CD56 pNK cell frequency measured as percentage of total lymphocyte or CD56 population by flowcytometry. 3 months
Secondary CD56 peripheral NK cell function Change in CD56 pNK cell function measured as percentage of CD56 degranulation by flowcytometry. 3 months
Secondary 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
Secondary Vaginal microbiome Change in taxonomic classification of vaginal microbiota of different subtypes but also classified in clustering of different subtypes. 3 months
Secondary Metabolic syndrome parameters I Change in cm waist circumference. 3 months
Secondary Metabolic syndrome parameters II Chance in mmHg blood pressure, both systolic as diastolic. 3 months
Secondary Metabolic syndrome parameters III Change in concentration (mg/dL) triglyceride. 3 months
Secondary Metabolic syndrome parameters IV Change in concentration (mg/dL) cholesterol levels. 3 months
Secondary Metabolic syndrome parameters V Change in concentration (mg/dL) blood sugar levels. 3 months
Secondary Sympathetic activity Change in baroreceptor sensitivity in ms/mmHg. 3 months
Secondary Uterine blood flow Change in pulsatility index, lower indicates better outcome. 3 months
Secondary Physical fitness Change in VO2max. 3 months
Secondary Pregnancy rate and live birth rate after one year of intervention, higher rater indicate better outcome. Questionnaire. 3 months
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