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Investigating the Influence of Contributing Factors on the Development of Uterine Fibroids in Women

Integrative Multiomics Study Of Uterine Fibroid Pathogenesis among Indian Women at Tertiary Health Care Centre (Ahmedabad) - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/078920
Enrollment
50
Registered
2025-01-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: D259- Leiomyoma of uterus, unspecified

Interventions

Intervention1: The study type is Diagnostic Interventional: The study type is diagnostic interventional and hence the blood samples collected from cases and controls will be subjected to tests like bi

Sponsors

GUJARAT STATE BIOTECHNOLOGY MISSION
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age and BMI-matched premenopausal women of 25-50 years of age from tertiary health care center in Ahmedabad, with different gynecological complaints. 2. All of them will receive an ultrasound scan. Among them, women with at least one fibroid (mean volume of = 2 cm3) will be recruited. 3. We will also recruit women who are willing to/undergoing hysterectomy surgery. 4. The rest of the patients who will have normal ultrasonography scans will be recruited as controls (i.e., non-fibroid patients).

Exclusion criteria

Exclusion criteria: 1. Women with Polycystic ovary syndrome, Endometriosis, Adenomyosis, pregnancy or pregnancy within the last 6 months. 2. Currently breastfeeding or breastfeeding within the last 6 months; history of acute or chronic neoplasm; history of smoking and alcohol consumption. 3. Hormonal treatment, including oral contraceptives and antibiotics, within the last 1 month.

Design outcomes

Primary

MeasureTime frame
Defining the relationship between the risk factors (Vitamin D, estrogen, and metabolic syndrome) of uterine fibroids with bile acids. Insight into the gene expression profiles of uterine smooth muscle cells, and revealing any positive association with bile acid. Insight into alterations in gut microbiota and its association with bile acid homeostasis in uterine fibroid patientsTimepoint: 1 Year—

Secondary

MeasureTime frame
Uncovering novel molecular targets or pathways that may help in early detection and prognosis of uterine fibroids.Timepoint: 8 Months—

Countries

India

Contacts

Public ContactSneha Mohan Nair

Gujarat Technological University School of Pharmacy

ap_kashyap@gtu.edu.in9427979959

Outcome results

None listed

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