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

NCT06624683 | Not Yet Recruiting DMC

• 1 other identifier: 2024-06-009BC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of warm-water footbaths in enhancing pregnancy rates during IVF and to explore the underlying mechanisms involved.

Conditions

Infertility; In Vitro Fertilization

Keywords

Infertility; In vitro fertilization; Stress; Sleep quality; Inflammation; Footbath

Outcome Measures

Primary Outcomes (1)

• pregnancy rate

  IVF success rates in infertile women

  28 days

Study Arms (2)

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.

Device: Intelligent footbath basin

usual care

NO INTERVENTION

clinical usual care

Interventions

Intelligent footbath basin DEVICE

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

intervation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, Taiwan

Location

MeSH Terms

Conditions

Infertility; Sleep Initiation and Maintenance Disorders; Inflammation

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chi-Hong Ho, PhD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Wen Shih, PhD

CONTACT

02-28227101; yawenny@ntunhs.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 3, 2024
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)