Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss

NCT06007560 | Active Not Recruiting DMC

• 1 other identifier: HMOVE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Recurrent Pregnancy Loss

Keywords

Natural Killer cells

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (14)

• CD56 endometrial NK cell phenotype

  3 months

• CD56 peripheral NK cell frequency

  3 months

• CD56 peripheral NK cell function

  3 months

• CD56 peripheral NK cell phenotype

  3 months

• Vaginal microbiome

  3 months

Study Arms (1)

<80% eNK

OTHER

Women with low eNK bright cell numbers, defined as \<80% of the total endometrial NK cell population

Other: Exercise

Interventions

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

<80% eNK

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Maastricht University Medical Center: collaborator

Study Sites (2)

Maastricht UMC+

Maastricht, 6202 AZ, Netherlands

Location

Radboud UMC

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tess Meuleman

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: August 23, 2023
• Study Start: March 21, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)