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Creating a Tool to Understand Physical, Emotional and Socio-cultural aspects of Women with PCOS related Infertility

Development and Validation of a Biopsychosocial Assessment Tool for Women with PCOS-Related Infertility - PCOS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/111550
Enrollment
51
Registered
2026-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

Rashmitha Shetty
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: PCOS Participants 1. Women aged 18-45 years who are coming for infertility treatment attending to Reproductive Medicine and Surgery, KMC, Manipal, MAHE, Manipal diagnosed with PCOS related infertility. 2. PCOS patients who speak either Kannada or Tulu or English. Healthcare Professionals 1. Fertility specialists 2. Gynaecologists and Obstetricians 3. Nurses working in fertility treatment 4. Senior Residents from Department of Reproductive Medicine and Surgery and Department of Obstetrics and Gynecology, KMC, MAHE, Manipal.

Exclusion criteria

Exclusion criteria: PCOS Participants 1. Thyroid disease 2. Cushing s syndrome 3. Congenital adrenal hyperplasia 4. Androgen-secreting tumors 5. Psychiatric illness 6. Long-term corticosteroids and antidepressants 7. Participants with previously diagnosed major psychiatric disorders taking antipsychotic drug will be excluded based on patient reported outcomes. Healthcare Professionals 1. Junior residents

Design outcomes

Primary

MeasureTime frame
1.Identification of major psychosocial themes experienced by women with PCOS-related infertility. 2.Development of a culturally appropriate questionnaire specific to South Indian women with PCOS-related infertility. Timepoint: At the end of the study

Secondary

MeasureTime frame
Timepoint: ;NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Varashree B S

Kasturba Medical College, Manipal.

rashmitha.kmcmpl2025@learner.manipal.edu8088129562

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026