Back to resultsAerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss (HMOVE)
Primary Purpose
Recurrent Pregnancy Loss
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Recurrent Pregnancy Loss focused on measuring Natural Killer cells
Eligibility Criteria
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
Sites / Locations
- Maastricht UMC+Recruiting
- Radboud UMCRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
<80% eNK
Arm Description
Women with low eNK bright cell numbers, defined as <80% of the total endometrial NK cell population
Outcomes
Primary Outcome Measures
CD56 endometrial NK cell frequency
Change in CD56 eNK cell frequency measured as percentage of total lymphocyte or total CD56 population by flowcytometry.
CD56 endometrial NK cell function
Change in CD56 eNK cell function measured as percentage of CD56 degranulation by flowcytometry.
Secondary Outcome Measures
CD56 endometrial NK cell phenotype
Change in CD56 eNK cell phenotype measured as percentage of (sub)population or mean fluorescent intensity respectively by flowcytometry.
CD56 peripheral NK cell frequency
Change in CD56 pNK cell frequency measured as percentage of total lymphocyte or CD56 population by flowcytometry.
CD56 peripheral NK cell function
Change in CD56 pNK cell function measured as percentage of CD56 degranulation by flowcytometry.
CD56 peripheral NK cell phenotype
Change in CD56 pNK cell phenotype measured as percentage of (sub)population or mean fluorescent intensity respectively by flowcytometry.
Vaginal microbiome
Change in taxonomic classification of vaginal microbiota of different subtypes but also classified in clustering of different subtypes.
Metabolic syndrome parameters I
Change in cm waist circumference.
Metabolic syndrome parameters II
Chance in mmHg blood pressure, both systolic as diastolic.
Metabolic syndrome parameters III
Change in concentration (mg/dL) triglyceride.
Metabolic syndrome parameters IV
Change in concentration (mg/dL) cholesterol levels.
Metabolic syndrome parameters V
Change in concentration (mg/dL) blood sugar levels.
Sympathetic activity
Change in baroreceptor sensitivity in ms/mmHg.
Uterine blood flow
Change in pulsatility index, lower indicates better outcome.
Physical fitness
Change in VO2max.
Pregnancy rate and live birth rate after one year of intervention, higher rater indicate better outcome.
Questionnaire.
Full Information
NCT ID
NCT06007560
First Posted
November 29, 2022
Last Updated
August 22, 2023
Sponsor
Radboud University Medical Center
Collaborators
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT06007560
Brief Title
Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss
Acronym
HMOVE
Official Title
Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center
Collaborators
Maastricht University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pregnancy Loss
Keywords
Natural Killer cells
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
<80% eNK
Arm Type
Other
Arm Description
Women with low eNK bright cell numbers, defined as <80% of the total endometrial NK cell population
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
CD56 endometrial NK cell frequency
Description
Change in CD56 eNK cell frequency measured as percentage of total lymphocyte or total CD56 population by flowcytometry.
Time Frame
3 months
Title
CD56 endometrial NK cell function
Description
Change in CD56 eNK cell function measured as percentage of CD56 degranulation by flowcytometry.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
CD56 endometrial NK cell phenotype
Description
Change in CD56 eNK cell phenotype measured as percentage of (sub)population or mean fluorescent intensity respectively by flowcytometry.
Time Frame
3 months
Title
CD56 peripheral NK cell frequency
Description
Change in CD56 pNK cell frequency measured as percentage of total lymphocyte or CD56 population by flowcytometry.
Time Frame
3 months
Title
CD56 peripheral NK cell function
Description
Change in CD56 pNK cell function measured as percentage of CD56 degranulation by flowcytometry.
Time Frame
3 months
Title
CD56 peripheral NK cell phenotype
Description
Change in CD56 pNK cell phenotype measured as percentage of (sub)population or mean fluorescent intensity respectively by flowcytometry.
Time Frame
3 months
Title
Vaginal microbiome
Description
Change in taxonomic classification of vaginal microbiota of different subtypes but also classified in clustering of different subtypes.
Time Frame
3 months
Title
Metabolic syndrome parameters I
Description
Change in cm waist circumference.
Time Frame
3 months
Title
Metabolic syndrome parameters II
Description
Chance in mmHg blood pressure, both systolic as diastolic.
Time Frame
3 months
Title
Metabolic syndrome parameters III
Description
Change in concentration (mg/dL) triglyceride.
Time Frame
3 months
Title
Metabolic syndrome parameters IV
Description
Change in concentration (mg/dL) cholesterol levels.
Time Frame
3 months
Title
Metabolic syndrome parameters V
Description
Change in concentration (mg/dL) blood sugar levels.
Time Frame
3 months
Title
Sympathetic activity
Description
Change in baroreceptor sensitivity in ms/mmHg.
Time Frame
3 months
Title
Uterine blood flow
Description
Change in pulsatility index, lower indicates better outcome.
Time Frame
3 months
Title
Physical fitness
Description
Change in VO2max.
Time Frame
3 months
Title
Pregnancy rate and live birth rate after one year of intervention, higher rater indicate better outcome.
Description
Questionnaire.
Time Frame
3 months
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tess Meuleman, Dr. MD.
Phone
0031-631133392
Email
tess.meuleman@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Habets, Dr.
Phone
0031-623385664
Email
denise.habets@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tess Meuleman
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht UMC+
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Habets, Dr.
Phone
0031-623385664
Email
denise.habets@mumc.nl
Facility Name
Radboud UMC
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tess Meuleman, Dr. MD.
Phone
0031-631133392
Email
tess.meuleman@radboudumc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
On reasonable special request only.
Learn more about this trial
Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss
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