InfertilityNCT06624683
Exploring the Effect of Footbaths on Increasing the Success Rates in Vitro Fertilization
A study testing Intelligent footbath basin in people with Infertility and In Vitro Fertilization, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
To evaluate the effectiveness of warm-water footbaths in enhancing pregnancy rates during IVF and to explore the underlying mechanisms involved. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, In Vitro Fertilization
- What is being tested?
- Intelligent footbath basin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women aged 18~45 years
- diagnosed with male factor infertility
- tubal factor infertility, or unexplained infertility, and undergoing an IVF treatment.
Who cannot join
- participants having adenomyosis, severe endometriosis
- a history of more than two IVF treatments
- any comorbidity or uncontrolled systemic diseases such as hypertension, diabetes, chronic heart disease or chronic renal disease that can affect the treatment process.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taipei University of Nursing and Health Sciences
Taipei
Ya-Wen Shih, PhD
About this study
Official title: Exploring the Effect of Footbaths on Increasing the Success Rates of in Vitro Fertilization and Its Associated Mechanism
To evaluate the effectiveness of warm-water footbaths in enhancing pregnancy rates during IVF and to explore the underlying mechanisms involved.
Read the detailed description
Additionally, this research will assess whether a complementary and alternative medicine (CAM) approach utilizing warm-water footbaths is effective in improving pregnancy rates for women undergoing IVF. Furthermore, the potential mechanisms by which footbaths may enhance IVF success rates will be elucidated.
The specific aims of this research proposal are as follows:
- To explore the correlation between health statuses, sleep quality, stress, and infertility incidence.
- To investigate the association between health statuses, sleep quality, stress, and multiple inflammatory indexes in infertile women, including: 2-1. Systemic immune inflammation index (SII) 2-2. Lymphocyte count (LC) 2-3. Platelet and neutrophil count product (PPN) 2-4. Platelet-lymphocyte ratio (PLR) 2-5. Neutrophil-lymphocyte ratio (NLR) 2-6. Lymphocyte-monocyte ratio (LMR)
- The effects of Footbaths on Stress and Sleep: To examine the effects of footbaths on reducing stress and improving sleep quality, which may enhance pregnancy success rates during IVF treatment in infertile women.
- The impact on Inflammatory Markers:
To investigate whether footbaths can reduce levels of inflammatory markers and inflammatory cytokines during IVF treatment, potentially enhancing pregnancy success rates in infertile women.
- Conditions
- Infertility, In Vitro Fertilization
- Being tested
- Intelligent footbath basin
- Keywords
- Infertility, In vitro fertilization, Stress, Sleep quality, Inflammation, Footbath
- Medical subject headings
- Infertility, Sleep Initiation and Maintenance Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent footbath basinDevice
before night sleep, takes 30 mins, starting from the first day of the menstrual cycle (MC) and continuing for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| intervation | Experimental | Participants in the intervention group will immerse their feet up to 10 cm into water inside a collapsible plastic container, maintaining a temperature of 40°C for 30 minutes every night, one hour before usual bedtime (between 21:00 and 22:00), starting from the first day of the menstrual cycle (MC) and continuing for 28 days. Receives: Device: Intelligent footbath basin |
| usual care | No intervention | clinical usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
IVF success rates in infertile women
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YA-WEN SHIH, National Taipei University of Nursing and Health Sciences
- Investigators
- Chi-Hong Ho, PhD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624683
- Sponsor's protocol ID
- 2024-06-009BC
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Footbaths on Increasing the Success Rates of in Vitro Fertilization and Its Associated Mechanism
- ClinicalTrials.gov ID
- NCT06624683
- Acronym / sponsor ID
- 2024-06-009BC
- Conditions
- Infertility, In Vitro Fertilization
- Keywords
- Infertility, In vitro fertilization, Stress, Sleep quality, Inflammation, Footbath
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 3 Oct 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.
To evaluate the effectiveness of warm-water footbaths in enhancing pregnancy rates during IVF and to explore the underlying mechanisms involved.
Detailed description
Additionally, this research will assess whether a complementary and alternative medicine (CAM) approach utilizing warm-water footbaths is effective in improving pregnancy rates for women undergoing IVF. Furthermore, the potential mechanisms by which footbaths may enhance IVF success rates will be elucidated.
The specific aims of this research proposal are as follows:
- To explore the correlation between health statuses, sleep quality, stress, and infertility incidence.
- To investigate the association between health statuses, sleep quality, stress, and multiple inflammatory indexes in infertile women, including: 2-1. Systemic immune inflammation index (SII) 2-2. Lymphocyte count (LC) 2-3. Platelet and neutrophil count product (PPN) 2-4. Platelet-lymphocyte ratio (PLR) 2-5. Neutrophil-lymphocyte ratio (NLR) 2-6. Lymphocyte-monocyte ratio (LMR)
- The effects of Footbaths on Stress and Sleep: To examine the effects of footbaths on reducing stress and improving sleep quality, which may enhance pregnancy success rates during IVF treatment in infertile women.
- The impact on Inflammatory Markers:
To investigate whether footbaths can reduce levels of inflammatory markers and inflammatory cytokines during IVF treatment, potentially enhancing pregnancy success rates in infertile women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervation | Experimental | Device: Intelligent footbath basinParticipants in the intervention group will immerse their feet up to 10 cm into water inside a collapsible plastic container, maintaining a temperature of 40°C for 30 minutes every night, one hour before usual bedtime (between 21:00 and 22:00), starting from the first day of the menstrual cycle (MC) and continuing for 28 days. |
| usual care | No intervention | –clinical usual care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women aged 18~45 years
- diagnosed with male factor infertility
- tubal factor infertility, or unexplained infertility, and undergoing an IVF treatment.
Key exclusion criteria (3 listed)
- participants having adenomyosis, severe endometriosis
- a history of more than two IVF treatments
- any comorbidity or uncontrolled systemic diseases such as hypertension, diabetes, chronic heart disease or chronic renal disease that can affect the treatment process.
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 |
|---|---|---|
| Intelligent footbath basinbefore night sleep, takes 30 mins, starting from the first day of the menstrual cycle (MC) and continuing for 28 days. | Device | intervation |
Primary outcome
pregnancy rate
Time frame: 28 days
IVF success rates in infertile women
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Chi-Hong Ho, PhD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent footbath basin in people with Infertility and In Vitro Fertilization, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Oct 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Wen Shih, PhD (02-28227101 ext. 3151, yawenny@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: 28 days). 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 3 Oct 2024.