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Efficacy of mind-body therapy on couples going through Frozen Embryo Transfer

Efficacy of mind body augmentation therapy on FET couples - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061753
Enrollment
28
Registered
2024-01-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z317- Encounter for procreative management and counseling for gestational carrier

Interventions

Intervention1: Comprehensive Psychosocial Health Intervention: The current interventional study is designed to provide comprehensive psychotherapy for reducing treatment distress and coping with infer

Sponsors

Sparcolife Digital Healthcare Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Provision of signed and dated informed consent form. 2. Willingness to adhere to the study intervention regimen. 3. Known cases of infertility diagnosed with Primary infertility and Secondary infertility. 4. Diagnosed with Female/male/combined/idiopathic infertility. 5. Age range: both partners range- 27-45 years. 6. Undergoing frozen embryo transfer (IVF) after approval from a medical doctor. 7. Only subjects whose ET is scheduled for at least 25 days later should be registered. Or more than three days after registration, the menstrual cycle is about to begin 8. The couples enrolling for the study should be English Speaking. 9. Access necessary resources for a technology-based intervention (i.e., computer, smartphone, internet access) 10. Psychiatric Severity: Mild to moderate (Hamilton Depression Rating Scale score = 16, Hamilton Anxiety Rating Scale (HAM-A) score = 24, and not reporting any current suicidal ideation or intent)

Exclusion criteria

Exclusion criteria: Not having consent from both partners or meeting the inclusion criteria Age of any partner above 45 years and below 27 years History of Severe Psychiatric Conditions as screened by a Registered Clinical Psychologist or Psychiatrist Couples opting for Surrogacy Any event medical condition or situation such that continued collection of follow-up study data would not be in the participants best interest or might require an additional treatment that would confound the interpretation of the study Treatment with another investigational drug or other intervention within the first 6 months Current smoker or tobacco use within 1 month

Design outcomes

Primary

MeasureTime frame
Increasing conception chances of couples undergoing infertility treatment in the Interventional group compared to the Control GroupTimepoint: 7 Weeks

Secondary

MeasureTime frame
Mitigating stress anxiety & emotional dysregulation among infertility treatment couples Improvement in Physical health & quality of life Improvement in quality of sleep or severity of insomnia Improvement in mindfulnessTimepoint: 8 Weeks

Countries

India

Contacts

Public ContactMeghana Siva

Sparcolife Digital Healthcare Technologies Private Limited

rayana@vyli.health7899321494

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026