Exploring the Effect of Footbaths on Increasing the Success Rates in Vitro Fertilization

NCT ID: NCT06624683

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-10-31

Brief Summary

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:

1. To explore the correlation between health statuses, sleep quality, stress, and infertility incidence.

2. 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)

3. 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.

4. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervation

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.

Group Type: EXPERIMENTAL

Intelligent footbath basin

Intervention Type: DEVICE

before night sleep, takes 30 mins, starting from the first day of the menstrual cycle (MC) and continuing for 28 days.

usual care

clinical usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intelligent footbath basin

before night sleep, takes 30 mins, starting from the first day of the menstrual cycle (MC) and continuing for 28 days.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• women aged 18~45 years
• diagnosed with male factor infertility
• tubal factor infertility, or unexplained infertility, and undergoing an IVF treatment.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

YA-WEN SHIH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chi-Hong Ho, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

National Taipei University of Nursing and Health Sciences

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Ya-Wen Shih, PhD

Role: CONTACT

yawenny@ntunhs.edu.tw

02-28227101 ext. 3151

Facility Contacts

Ya-Wen Shih, PhD

Role: primary

Other Identifiers

2024-06-009BC

Identifier Type: -

Identifier Source: org_study_id