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

National Taipei University of Nursing and Health Sciences

Status: Not yet enrolling

Conditions: In Vitro Fertilization; Infertility

Treatments: Device: Intelligent footbath basin

Study type: Interventional

Funder types: Other

Identifiers

NCT06624683

2024-06-009BC

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

intervation

Experimental group

Description:

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.

Treatment:

Device: Intelligent footbath basin

usual care

No Intervention group

Description:

clinical usual care