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.
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
Dr Anuradha Roy
Banaras Hindu University, Varanasi