FertilitySF/ActivityNCT06705712
Physical Activity, Fertility, and Spontaneous Abortion in Danish Couples Trying to Conceive
A study testing Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive. in people with Fertility and Fecundability, run by University of Aarhus at 1 site in Denmark.
Trial summary
Physical activity in both the preconception period and during pregnancy may enhance the probability of getting pregnant and reduce the risks of complications during pregnancy. Adults, including pregnant women without complications, are recommended to be physically active for at least 30 minutes per day to maintain… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility, Fecundability, Time-to-Pregnancy
- What is being tested?
- Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2025to 31 Dec 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 18-49 years
- In a relationship with a male partner
- Trying to conceive
Who cannot join
- Using birth control
- Receiving fertility treatment
- Have been trying to conceive for more than six months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Clinical Epidemiology
Aarhus, 8200
Anne Sofie Dam Laursen, Assoc. Prof, +4587167237, asdl@clin.au.dk
About this study
Official title: A Preconception Cohort Study of Physical Activity, Fertility, and Spontaneous Abortion - Including a Randomized Controlled Trial.
Physical activity in both the preconception period and during pregnancy may enhance the probability of getting pregnant and reduce the risks of complications during pregnancy. Adults, including pregnant women without complications, are recommended to be physically active for at least 30 minutes per day to maintain physical and mental health. Nonetheless, many women reduce their level of exercise during early pregnancy.
With this project, we will test the effectiveness of receiving motivational counseling on physical activity (PA) among women trying to conceive and during the first trimester of the pregnancy if they conceive. We will further investigate whether PA is associated with fecundability, spontaneous abortion (SAB) and other birth outcomes, i.e., gestational diabetes, preeclampsia, and birth weight.
Read the detailed description
Infertility, defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse, and spontaneous abortion (SAB) are significant public health problems, affecting up to 20% of reproductive age couples in the Western World. A large proportion of couples seek fertility treatment, which is not only an economic burden for the society, but also associated with adverse health effects among infertile couples. The causes of both infertility and SAB are multifactorial and identification of modifiable risk factors is an important public health goal.
According to the Danish Health Authority, adults are recommended to be physically active for at least 30 minutes per day, to undertake muscle-strengthening activities on two or more days per week and to reduce sedentary time. The same applies for pregnant women without complications. However, only 15-38% of pregnant women adhere to the recommendations for PA and many women reduce their level of exercise during early pregnancy compared with pre-pregnancy. Yet, maternal health in both the preconception period and during pregnancy is critical to avoid complications during pregnancy and for the long-term health of mother and child.
We therefore aim to investigate the association between PA, fecundability (i.e., the average per-cycle probability of conception), and SAB. An efficient web-based infrastructure to recruit, follow, and collect comprehensive data has already been developed. In the ongoing prospective cohort study, SnartForældre.dk (SF), we investigate fecundability and SAB according to demographic, behavioral, environmental, and medical factors and have enrolled more than 10,000 women and 1,700 of their male partners who are trying to conceive without fertility treatment.
In the present SF sub-study, SnartForældre.dk/Aktivitet, we aim to conduct a two-armed randomized controlled trial with 500 women included, to investigate the effectiveness of receiving motivational counseling on physical activity (PA) among women trying to conceive and during the first trimester of the pregnancy if they conceive. We will further investigate whether PA is associated with fecundability, spontaneous abortion (SAB) and other birth outcomes, i.e., gestational diabetes, preeclampsia, and birth weight. As we will be able to combine self-reported data, objectively measured data on PA, and high-quality Danish registry data, we have a unique possibility to evaluate the impact of PA on fecundability and SAB, as well as other pregnancy complications and birth outcomes, in a way that is hardly possible in any other country.
The study will provide important knowledge that will be of interest for the scientific world, health professionals, and for couples who suffer from infertility or experience SABs.
- Conditions
- Fertility, Fecundability, Time-to-Pregnancy, Spontaneous Abortion, Pregnancy Outcome, Pregnancy Complications
- Being tested
- Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive.
- Keywords
- Exercise, Physical activity, Sedentary behaviour, Fertility, Spontaneous abortion, Preconception care, Fecundability, Time to pregnancy
- Medical subject headings
- Abortion, Spontaneous, Pregnancy Complications, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive.Behavioural
All participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) which will be connected with an application, Fitrockr. Data from the devices will be linked to data from the Snartforældre-questionnaires. The participants are asked to wear the tracker 24/7 during preconception and during the first trimester of their pregnancy if they conceive within 12 months.
Participants will receive information material and be asked to set goals for their PA level. To follow-up on the goal setting, they will receive two phone calls, where the conversations will be inspired by motivational interviewing.
| Study group | Role | What they receive |
|---|---|---|
| Control group: Usual physical activity habits | No intervention | The participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) including clear instructions on how to use the tracker and how to connect to a software (Fitrockr). We ask the participants to wear the tracker 24/7 during the period they are trying to conceive and during the first trimester of their pregnancy if they conceive within 12 months to measure physical activity. Participants in the control group will not receive any PA feedback. Participants are advised to maintain their usual activity habits. |
| Intervention group: Changing physical activity habits | Experimental | The participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) including clear instructions on how to use it. They will be asked to wear the tracker 24/7 during the period they are trying to conceive plus the first trimester of their pregnancy. They will receive information material on the Danish national guidelines on PA, health benefits from PA, and suggestions on how to reduce sedentary behavior and increase daily activity. Based on the current PA level, they are asked to set personal goals to meet the PA recommendations and to split up sedentary behavior. They will receive a phone call two and five weeks after they received the activity tracker, to stimulate the participant's motivation to be physically active, to set goals for maintaining or increasing PA and to facilitate a revision of the goals if needed.
The conversations will be inspired by motivational interviewing and the principles of this motivational technique. Receives: Behavioral: Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Physical activity will be objectively measured continuously (24/7) using wrist-worn activity trackers with triaxial accelerometry.
Measured: From randomization to end of study or censoring event, no more than 15 months
Time to pregnancy (TTP)
TTP will be estimated by using variables from baseline and follow-up questionnaires. In each follow-up questionnaire, women report the date of the first day of their last menstrual period (LMP), whether they are currently pregnant, and whether they experienced any other pregnancies (SAB, induced abortion, or ectopic pregnancy) since their last questionnaire. For irregularly cycling women, we estimate cycle length based on baseline LMP date, expected date of next menses, and LMP recorded during follow-up.
Measured: From baseline until they report a pregnancy or a censoring event (12 cycles of follow-up, cessation of pregnancy attempt, initiation of fertility treatment, withdrawal or loss to follow-up), no more than 12 months
Spontaneous abortion
Spontaneous abortion (SAB), defined as an intrauterine pregnancy loss before week 22 of gestation, will be identified from both bimonthly follow-up questionnaires and registries. In follow-up questionnaires, women report if they have had a pregnancy loss since the date of the most recent completed questionnaire as well as the date of loss and the gestational age at loss. Using the civil registration number (CPR), we will retrieve data from the Danish National Patient Registry (DNPR) and the Danish Medical Birth Registry (DMBR) to identify SABs and induced abortions occurring after the baseline enrollment date. For SABs identified from both registry and questionnaire data, we will use data from the DNPR (based on early ultrasound fetometry or LMP) to ascertain the time of SAB.
Measured: From reported pregnancy until spontaneous abortion or censoring event (≥22 weeks' gestation, emigration, medically induced abortion or ectopic pregnancy), no more than 22 weeks from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SnartForældre/Activity is designed as a two-armed randomized controlled trial, including 530 women, who are trying to conceive. Included participants will be randomized in a 1:1 ratio to an intervention group or a control group. The participates are followed during preconception for up to a year or until they conceive. The participants who conceive during the study period are followed during their first trimester of the pregnancy or until they experience a pregnancy loss. Collection of data for assessment of the outcomes was through bimonthly follow-up questionnaires linked with registry data. Time frames and methods for assessment of outcomes are specified elsewhere.
- Masking
- None (open label)
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Sofie Dam Laursen, cand.scient, ph.d.,, Study chair, Department of Clinical Epidemiology, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705712
- Sponsor's protocol ID
- 1-10-72-174-23
- Acronym
- SF/Activity
- Status last verified
- Jun 2024
- First submitted
- 29 Oct 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preconception Cohort Study of Physical Activity, Fertility, and Spontaneous Abortion - Including a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06705712
- Acronym / sponsor ID
- SF/Activity / 1-10-72-174-23
- Conditions
- Fertility, Fecundability, Time-to-Pregnancy, Spontaneous Abortion, Pregnancy Outcome, Pregnancy Complications
- Keywords
- Exercise, Physical activity, Sedentary behaviour, Fertility, Spontaneous abortion, Preconception care, Fecundability, Time to pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Nov 2024 (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.
Physical activity in both the preconception period and during pregnancy may enhance the probability of getting pregnant and reduce the risks of complications during pregnancy. Adults, including pregnant women without complications, are recommended to be physically active for at least 30 minutes per day to maintain physical and mental health. Nonetheless, many women reduce their level of exercise during early pregnancy.
With this project, we will test the effectiveness of receiving motivational counseling on physical activity (PA) among women trying to conceive and during the first trimester of the pregnancy if they conceive. We will further investigate whether PA is associated with fecundability, spontaneous abortion (SAB) and other birth outcomes, i.e., gestational diabetes, preeclampsia, and birth weight.
Detailed description
Infertility, defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse, and spontaneous abortion (SAB) are significant public health problems, affecting up to 20% of reproductive age couples in the Western World. A large proportion of couples seek fertility treatment, which is not only an economic burden for the society, but also associated with adverse health effects among infertile couples. The causes of both infertility and SAB are multifactorial and identification of modifiable risk factors is an important public health goal.
According to the Danish Health Authority, adults are recommended to be physically active for at least 30 minutes per day, to undertake muscle-strengthening activities on two or more days per week and to reduce sedentary time. The same applies for pregnant women without complications. However, only 15-38% of pregnant women adhere to the recommendations for PA and many women reduce their level of exercise during early pregnancy compared with pre-pregnancy. Yet, maternal health in both the preconception period and during pregnancy is critical to avoid complications during pregnancy and for the long-term health of mother and child.
We therefore aim to investigate the association between PA, fecundability (i.e., the average per-cycle probability of conception), and SAB. An efficient web-based infrastructure to recruit, follow, and collect comprehensive data has already been developed. In the ongoing prospective cohort study, SnartForældre.dk (SF), we investigate fecundability and SAB according to demographic, behavioral, environmental, and medical factors and have enrolled more than 10,000 women and 1,700 of their male partners who are trying to conceive without fertility treatment.
In the present SF sub-study, SnartForældre.dk/Aktivitet, we aim to conduct a two-armed randomized controlled trial with 500 women included, to investigate the effectiveness of receiving motivational counseling on physical activity (PA) among women trying to conceive and during the first trimester of the pregnancy if they conceive. We will further investigate whether PA is associated with fecundability, spontaneous abortion (SAB) and other birth outcomes, i.e., gestational diabetes, preeclampsia, and birth weight. As we will be able to combine self-reported data, objectively measured data on PA, and high-quality Danish registry data, we have a unique possibility to evaluate the impact of PA on fecundability and SAB, as well as other pregnancy complications and birth outcomes, in a way that is hardly possible in any other country.
The study will provide important knowledge that will be of interest for the scientific world, health professionals, and for couples who suffer from infertility or experience SABs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SnartForældre/Activity is designed as a two-armed randomized controlled trial, including 530 women, who are trying to conceive. Included participants will be randomized in a 1:1 ratio to an intervention group or a control group. The participates are followed during preconception for up to a year or until they conceive. The participants who conceive during the study period are followed during their first trimester of the pregnancy or until they experience a pregnancy loss. Collection of data for assessment of the outcomes was through bimonthly follow-up questionnaires linked with registry data. Time frames and methods for assessment of outcomes are specified elsewhere.
| Arm | Type | Receives |
|---|---|---|
| Control group: Usual physical activity habits | No intervention | –The participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) including clear instructions on how to use the tracker and how to connect to a software (Fitrockr). We ask the participants to wear the tracker 24/7 during the period they are trying to conceive and during the first trimester of their pregnancy if they conceive within 12 months to measure physical activity. Participants in the control group will not receive any PA feedback. Participants are advised to maintain their usual activity habits. |
| Intervention group: Changing physical activity habits | Experimental | Behavioral: Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive.The participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) including clear instructions on how to use it. They will be asked to wear the tracker 24/7 during the period they are trying to conceive plus the first trimester of their pregnancy. They will receive information material on the Danish national guidelines on PA, health benefits from PA, and suggestions on how to reduce sedentary behavior and increase daily activity. Based on the current PA level, they are asked to set personal goals to meet the PA recommendations and to split up sedentary behavior. They will receive a phone call two and five weeks after they received the activity tracker, to stimulate the participant's motivation to be physically active, to set goals for maintaining or increasing PA and to facilitate a revision of the goals if needed. The conversations will be inspired by motivational interviewing and the principles of this motivational technique. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- 18-49 years
- In a relationship with a male partner
- Trying to conceive
Key exclusion criteria (3 listed)
- Using birth control
- Receiving fertility treatment
- Have been trying to conceive for more than six months
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 |
|---|---|---|
| Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive.All participants will receive a wrist-worn activity tracker (Garmin VívoSmart 5) which will be connected with an application, Fitrockr. Data from the devices will be linked to data from the Snartforældre-questionnaires. The participants are asked to wear the tracker 24/7 during preconception and during the first trimester of their pregnancy if they conceive within 12 months. Participants will receive information material and be asked to set goals for their PA level. To follow-up on the goal setting, they will receive two phone calls, where the conversations will be inspired by motivational interviewing. | Behavioural | Intervention group: Changing physical activity habits |
Primary outcome
Physical activity
Time frame: From randomization to end of study or censoring event, no more than 15 months
Physical activity will be objectively measured continuously (24/7) using wrist-worn activity trackers with triaxial accelerometry.
Time to pregnancy (TTP)
Time frame: From baseline until they report a pregnancy or a censoring event (12 cycles of follow-up, cessation of pregnancy attempt, initiation of fertility treatment, withdrawal or loss to follow-up), no more than 12 months
TTP will be estimated by using variables from baseline and follow-up questionnaires. In each follow-up questionnaire, women report the date of the first day of their last menstrual period (LMP), whether they are currently pregnant, and whether they experienced any other pregnancies (SAB, induced abortion, or ectopic pregnancy) since their last questionnaire. For irregularly cycling women, we estimate cycle length based on baseline LMP date, expected date of next menses, and LMP recorded during follow-up.
Spontaneous abortion
Time frame: From reported pregnancy until spontaneous abortion or censoring event (≥22 weeks' gestation, emigration, medically induced abortion or ectopic pregnancy), no more than 22 weeks from study entry
Spontaneous abortion (SAB), defined as an intrauterine pregnancy loss before week 22 of gestation, will be identified from both bimonthly follow-up questionnaires and registries. In follow-up questionnaires, women report if they have had a pregnancy loss since the date of the most recent completed questionnaire as well as the date of loss and the gestational age at loss. Using the civil registration number (CPR), we will retrieve data from the Danish National Patient Registry (DNPR) and the Danish Medical Birth Registry (DMBR) to identify SABs and induced abortions occurring after the baseline enrollment date. For SABs identified from both registry and questionnaire data, we will use data from the DNPR (based on early ultrasound fetometry or LMP) to ascertain the time of SAB.
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 28 Jan 2025.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Fertility
Not yet recruiting
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
Diminished Ovarian Reserve (DOR)
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
Active, not recruiting
Ovarian Tissue Cryopreservation in Children
Cancer
Not yet recruitingObservational study
Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue
Fertility, Testicular Tissue Cryopreserved
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.
Anne Sofie Dam Laursen, cand.scient, ph.d., study chair
Department of Clinical Epidemiology, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of activity trackers and motivational conversations to enhance focus on physical activity among women trying to conceive. in people with Fertility and Fecundability, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Contact Sissel Jessen Weissert, MD (+45 87 15 02 67, sw@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: From randomization to end of study or censoring event, no more than 15 months). The study lists 3 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 28 Jan 2025.