Recurrent Pregnancy LossHMOVENCT06007560
Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss
A study testing Exercise in people with Recurrent Pregnancy Loss, run by Radboud University Medical Center at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesNetherlands
- Study dates
- 21 Mar 2022to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maastricht UMC+
Maastricht, 6202 AZ
Radboud UMC
Nijmegen, 6500 HB
About this study
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
- Being tested
- Exercise
- Keywords
- Natural Killer cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| <80% eNK | Other | Women with low eNK bright cell numbers, defined as <80% of the total endometrial NK cell population Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD56 endometrial NK cell frequency
Change in CD56 eNK cell frequency measured as percentage of total lymphocyte or total CD56 population by flowcytometry.
Measured: 3 months
CD56 endometrial NK cell function
Change in CD56 eNK cell function measured as percentage of CD56 degranulation by flowcytometry.
Measured: 3 months
Secondary outcomes (14)
CD56 endometrial NK cell phenotype
Change in CD56 eNK cell phenotype measured as percentage of (sub)population or mean fluorescent intensity respectively by flowcytometry.
Measured: 3 months
CD56 peripheral NK cell frequency
Change in CD56 pNK cell frequency measured as percentage of total lymphocyte or CD56 population by flowcytometry.
Measured: 3 months
CD56 peripheral NK cell function
Change in CD56 pNK cell function measured as percentage of CD56 degranulation by flowcytometry.
Measured: 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.
Measured: 3 months
Vaginal microbiome
Change in taxonomic classification of vaginal microbiota of different subtypes but also classified in clustering of different subtypes.
Measured: 3 months
Metabolic syndrome parameters I
Change in cm waist circumference.
Measured: 3 months
Metabolic syndrome parameters II
Chance in mmHg blood pressure, both systolic as diastolic.
Measured: 3 months
Metabolic syndrome parameters III
Change in concentration (mg/dL) triglyceride.
Measured: 3 months
Metabolic syndrome parameters IV
Change in concentration (mg/dL) cholesterol levels.
Measured: 3 months
Metabolic syndrome parameters V
Change in concentration (mg/dL) blood sugar levels.
Measured: 3 months
Sympathetic activity
Change in baroreceptor sensitivity in ms/mmHg.
Measured: 3 months
Uterine blood flow
Change in pulsatility index, lower indicates better outcome.
Measured: 3 months
Physical fitness
Change in VO2max.
Measured: 3 months
Pregnancy rate and live birth rate after one year of intervention, higher rater indicate better outcome.
Questionnaire.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start21 Mar 2022
- Primary completion1 Dec 2024
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies of the same condition, open and under way.
- More trials run by Radboud 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Principal investigator, Tess Meuleman, Radboud University Medical Center
- Investigators
- Tess Meuleman, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007560
- Sponsor's protocol ID
- HMOVE
- Acronym
- HMOVE
- Status last verified
- Apr 2025
- First submitted
- 29 Nov 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On reasonable special request only.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT06007560
- Acronym / sponsor ID
- HMOVE / HMOVE
- Conditions
- Recurrent Pregnancy Loss
- Keywords
- Natural Killer cells
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 23 Aug 2023 (actual)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| <80% eNK | Other | Other: ExerciseWomen with low eNK bright cell numbers, defined as <80% of the total endometrial NK cell population |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- Age above 40 years
- BMI above 40
- Current use of immunosuppressive or biological drugs
- Current use of hormone conceptive
- HIV positivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAerobe 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 | Other | <80% eNK |
Primary outcome
CD56 endometrial NK cell frequency
Time frame: 3 months
Change in CD56 eNK cell frequency measured as percentage of total lymphocyte or total CD56 population by flowcytometry.
CD56 endometrial NK cell function
Time frame: 3 months
Change in CD56 eNK cell function measured as percentage of CD56 degranulation by flowcytometry.
14 secondary outcomes
CD56 endometrial NK cell phenotype
Time frame: 3 months
CD56 peripheral NK cell frequency
Time frame: 3 months
CD56 peripheral NK cell function
Time frame: 3 months
CD56 peripheral NK cell phenotype
Time frame: 3 months
Vaginal microbiome
Time frame: 3 months
Metabolic syndrome parameters I
Time frame: 3 months
Metabolic syndrome parameters II
Time frame: 3 months
Metabolic syndrome parameters III
Time frame: 3 months
Metabolic syndrome parameters IV
Time frame: 3 months
Metabolic syndrome parameters V
Time frame: 3 months
Sympathetic activity
Time frame: 3 months
Uterine blood flow
Time frame: 3 months
Physical fitness
Time frame: 3 months
Pregnancy rate and live birth rate after one year of intervention, higher rater indicate better outcome.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No. On reasonable special request only.
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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.
Tess Meuleman principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Recurrent Pregnancy Loss, run by Radboud University Medical Center at 2 sites 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 2 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD56 endometrial NK cell frequency (time frame: 3 months). 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 6 Apr 2025.