Exercise training in women with unexplained recurrent pregnancy loss to optimize receptive endometrial NK cell population and functio

Recruiting

Conditions: reproductieve immunologie
recurrent miscarriage
Recurrent pregnancy losses
10000211

Registration Number: NL-OMON55979

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Women with two or more unexplained pregnancy losses, defined as women without
uterine abnormalities, antiphospholipid syndrome, thyroid abnormalities and
abnormal parental karyotyping if indicated 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
-Use of immunosuppressive drugs, biological or antidepressants
-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
-Smoking or use of medication or supplements that might affect the
cardiovascular system
-Vaccination (i.e Covid) within 3 months prior to or during sampling and
intervention
-New pregnancy at time of measurements, breastfeeding
-Current or recent (<3 months ago) pregnancy
-Women with plans to become pregnant during the course of intervention
-(Physical) inabilities to follow moderate aerobe cycling training
-Participants who are not capable of signing the informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>CD56bright NK cell population and function in endometrium and peripheral blood<br /><br>in women with reduced endometrial NK cells (<80%).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Frequency and function of (CD56bright) eNK cells compared to baseline in women<br /><br>with unexplained RPL and more than 80% of eNK cells. General immune assessment<br /><br>of all samples (<80% and >80% eNK cells) for peripheral NK cells (before and<br /><br>after 12 weeks of an aerobe exercise intervention) and endometrial NK cells<br /><br>(before, during and after 12 weeks of an aerobe exercise intervention) in the<br /><br>intervention group and time control group. Additional to the immunological<br /><br>effects we will study the effects of exercise training on the vaginal<br /><br>microbiota, on cardiovascular and metabolic parameters, on autonomic balance,<br /><br>on uterine blood flow and on physical fitness levels. One year after completion<br /><br>of the intervention, pregnancy rate and live birth rate will be assessed. </p><br>