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Clinical Trials/CTRI/2025/02/080959
CTRI/2025/02/080959Not yet recruitingPhase 3 4

A diagnostic and Ayurvedic therapeutic approach for endometrial receptivity in patients of polycystic ovarian syndrome based on Radiological Uterine biophysical profile, Immunohistochemistry and Gene expression.

Institute of EminenceIOE2 sites in 1 country10 target enrollmentStarted: March 2, 2025Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
10
Locations
2
Primary Endpoint
diagnostic alteration in endometrial receptivity

Study Overview

Brief Summary

Gap in knowledge :As many previous published researches showed that uttarabasti

has role in improving the chances of conception and enhanced fertility but no work

has been done to show effect of uttarabasti on markers of endometrial receptivity in

specific.

Novelty :The present study framed mainly for disorders of endometrial receptivity in

patients with PCOS, where we planned to see the differences in the indicators of

endometrial receptivity including Applebaum’s score via sonography, alphavbeta3integrin via immunihistochemical study and 7 genes expression (related to

endometrial receptivity as per previous published research work) between PCOS

diagnosed female patients with fertile females having live births as control group

Objectives :Assessment of Applebaum’s score, AlphaVBeta3 integrin expression

and expression of 7 genes related to endometrial receptivity (HOXA10, HOXA11,

LIF, AR, Mucin1, PGR, alphavbeta3) during implantation window in patients of

PCOS.

Methods :Itwill be an open label controlled clinical trial and the setting site will be

the BHU,Varanasi.

Expected outcome :Uttarabasti can improve endometrial receptivity by increasing,

Applebaum’s score, alphavbeta3 integrin expression and by up regulating gene

expression during implantation window in patients of PCOS.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
21.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Diagnosed cases of PCOS yearning conception.
  • Patient giving consent for uttarabasti procedure and investigations And willing for follow ups.

Exclusion Criteria

  • <21 years and >40 years of age patient.
  • Unmarried PCOS patients Patients with huge myoma and adenomyosis.
  • Extensive cervical erosion and vaginal infection.
  • HIV, HBsAg, HCV positive Patients.

Outcomes

Primary Outcomes

diagnostic alteration in endometrial receptivity

Time Frame: baseline, after 12 weeks

Secondary Outcomes

  • endometrial receptivity improvements(baseline, after 4weeks, after 8 weeks)

Investigators

Sponsor
Institute of EminenceIOE
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Anuradha Roy

Banaras Hindu University, Varanasi

Study Sites (2)

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