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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility; In Vitro Fertilization
• Intervention / Treatment: Device: Intelligent footbath basin

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya-Wen Shih, PhD; Phone Number: 3151 02-28227101; Email: yawenny@ntunhs.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taipei University of Nursing and Health Sciences
    • Contact: Ya-Wen Shih, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Intelligent footbath basin; before night sleep, takes 30 mins, starting from the first day of the menstrual cycle (MC) and continuing for 28 days.
No Intervention: usual care; clinical usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy rate	IVF success rates in infertile women	28 days

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Investigators: Principal Investigator: Chi-Hong Ho, PhD, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Stress; Infertility; Sleep quality; In vitro fertilization; Footbath
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 2024-06-009BC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No