Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss

Recurrent Pregnancy Loss Clinical Trial

— HMOVE  

Official title:

Aerobe Cycling Training in Women With Unexplained Recurrent Pregnancy Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007560
• Other study ID #: HMOVE
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Fetal Death
• Recurrence
• Recurrent Pregnancy Loss

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