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

Not Applicable

Not yet recruiting

• Conditions: Infertility; In Vitro Fertilization
• Interventions: Device: Intelligent footbath basin

• Registration Number: NCT06624683
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

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.

Study Timeline

• Study First Submitted: 2024-09-30
• Status Verified: 2024-10
• Study Start: 2024-10
• Study First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-07
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervation	Intelligent footbath basin	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.

Primary Outcome Measures

Name	Time	Method
pregnancy rate	28 days	IVF success rates in infertile women

Trial Locations

Locations (1)

National Taipei University of Nursing and Health Sciences; 🇨🇳 Taipei, Taiwan