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Understanding the role of iron in women with polycystic ovarian syndrome

Deciphering the association between iron homeostasis and ovarian function in polycystic ovarian syndrome - PCOS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058263
Enrollment
312
Registered
2023-10-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Health Condition 1: N399- Disorder of urinary system, unspecified

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Manipal Academy of Higher Education
Lead Sponsor
DST INSPIRE
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Control group: Infertile women attending the infertility clinic will be recruited for the study. Women with male factor infertility, normal BMI , regular menstrual cycles and no clinical signs of hyperandrogenism will be considered as control population. Obese group: Women with high BMI > 25kg/m2 and no clinical signs of hyperandrogenism will be considered under obese, non-PCOS group. PCOS group: Women with PCOS pattern (with metformin and without metformin treatment) will be included in the study. For PCOS group, women diagnosed with PCOS based on the Rotterdam criteria and undergo ovary stimulation will be selected. In addition, women with Type 2 diabetes will be included in this study group. PCOS + Metformin group: For PCOS with metformin group, women diagnosed with PCOS and Type 2 diabetes, undergoing metformin treatment for at least one month will be included.

Exclusion criteria

Exclusion criteria: Women with chronic cardiovascular disease, chronic kidney disease, diabetes, thyroid disease, and pulmonary disease will be excluded from the study. In addition, women using sex-steroids, women who had ovarian surgery in the past, women with premature ovarian failure and women who had chemotherapy in the past will be excluded.

Design outcomes

Primary

MeasureTime frame
The study aims at understanding the complex pathophysiology of PCOS from the lens of altered iron metabolism/overload in the maternal body and also within the follicular fluid. This data is lacking in the Indian context and may provide vital clues to the pathophysiology treatment and management of PCOSTimepoint: 3 years

Secondary

MeasureTime frame
The association between the iron metabolism & ovarian function, its possible role as a causative factor for anovulation, poor oocyte function, poor embryo development & implantation process will be understood from this studyTimepoint: 3 years

Countries

India

Contacts

Public ContactDr Sandhya Kumari M V

Kasturba Medical College

guru.kalthur@manipal.edu919886300179

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026