Skip to content

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.

Effectiveness of modified mindfulness based cognitive therapy in distressed couples with infertility, undergoing intra-uterine insemination.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/07/005973
Enrollment
30
Registered
2015-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Primary Infertility

Interventions

Intervention1: The type of intervention offered in this study is behavioural in nature. It is named as PSYCHOTHERAPY, as is an evidence based treatment modality offered to individuals with significant
a response is deliberate and considered action. 4.With Non-judgementally : The temptation is t

Sponsors

Selfsponsored
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Secondary

MeasureTime frame
ii. Mindfulness skills : Assessed by Kentucky Inventory for Mindfulness Skills 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 Timepoint: Pre to post intervention, 1 month

Primary

MeasureTime frame
Infertility Specific Stress assessed by Fertility Problem InventoryTimepoint: Pre to Post Intervention, 1 month

Countries

India

Contacts

Public ContactMs Ansha Patel

Dept of Psychiatry, Kasturba Medical College, Manipal.

psvn.sharma@manipal.edu

Outcome results

None listed

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