The study is a a clinical trial to study the effectiveness of psychotherapy in reducing emotional distress in infertility couples, while they undergo infertility treatment (IUI) and face unsuccessful outcomes in such treatment cycles.

Phase 2

Completed

• Conditions: Health Condition 1: null- Primary Infertility

• Registration Number: CTRI/2015/07/005973
• Lead Sponsor: Selfsponsored

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-02-02
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 192

Inclusion Criteria

Inclusion Criteria

•Persons who give consent for the study, with female partner of couple of Age 20 years to 35 years , Educated at least up to 10th standard and should be able to read and write Kannada.

•Couples who are coming as new cases to MARC , with p/h/o diagnosis of primary infertility

•Patients who have 5-10 years of p/h/o undergoing Assisted Reproductive Treatments

•Couples with PCOD in female partner and /or oligospermia and varicocele in male partner

•Suitable for intra-uterine insemination

•Neither partner of the couple meets any diagnostic criteria on Mini International Neuropsychiatric Interview ( English version 5.0).

•Having a significant infertility specific stress score , in either partner of the couple ,( i.e. raw score of 167 or above as assessed in females and of 147 or above as assessed in males) as measured on Fertility Problem Inventory.

Exclusion Criteria

•Couples with >10 years of diagnosis of primary infertility and p/h/o undergoing Assisted Reproductive Treatments.

•Couples who have undergone surgery in the last 3 months .

•Couples who are going to under surgeries in the coming 3 months

•Couples suitable for IVF

•Couples suitable for donor egg/ donor insemination

•Couples in which female partner has a diagnosis of recent cyst/ fibroids/ endometrioses and /or males with a diagnosis of azoospermia/aspermia.

•Couples in which either partner with diagnosed with any psychiatric disorder or on Rx for psychiatric comorbidities ,or meets the diagnostic criteria on Mini International Neuropsychiatric Interview ( English version 5.0).

•Having an insignificant infertility specific stress score in both the partner of the couple ( raw score of or less than 167 as assessed in females and equal/less than 147 as assessed in males) as measured on Fertility Problem Inventory.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infertility Specific Stress assessed by Fertility Problem InventoryTimepoint: Pre to Post Intervention, 1 month

Secondary Outcome Measures

Name	Time	Method
ii.Mindfulness skills : Assessed by Kentucky Inventory for Mindfulness Skills <br/ ><br>Timepoint: Pre to Post intervention, 1 months;iii.Anxiety and Depression: Assessed by Hamilton anxiety and depression scale.Timepoint: Pre to Post Intervention, 1 month;v.Fertility related Quality of life : Assessed by Ferti QOL <br/ ><br>Timepoint: Pre to post intervention, 1 month