Gene expression and proteomic profiles in patients with unexplained recurrent pregnancy loss and unexplained infertility versus fertile controls.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- ICMR
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- To characterize and compare gene expression and perform proteomic profiles to identify and quantify proteins in the biological samples of patients with unexplained infertility and unexplained recurrent pregnancy loss compared to fertile women.
Study Overview
Brief Summary
This observational case control study aims to evaluate gene expression and proteomic profiles in endometrial tissue and serum of women with unexplained infertility and unexplained pregnancy loss compared to fertile controls. On day 21 of menstrual cycle, endometrial biopsy and blood samples will be collected. Gene expression of BCL6, HOXA10, MUC1, IL6, TNF alpha, LIF and VEGF will be evaluated by quantitative PCR. Protein expression will be evaluated by western blot and immunohistochemistry. Serum cytokine levels will be measured by ELISA. The study will compare molecular patterns between groups to identify potential biomarkers and pathways related to endometrial receptivity , immune regulation and inflammation.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 21.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •All patients with history of unexplained infertility ( when women had normal ovulatory menstrual cycles, had atleast one patent fallopian tube and their partners had normal semen analysis) and unexplained recurrent pregnancy loss attending the FRC department of IOG will be included in the study as cases.
- •Controls will be normal fertile women attending our gynaecological OPD for general complaints, women with normal menstrual cycles, with proven fertility.
Exclusion Criteria
- •women more than 40 years, those identified with specific causes of infertility such as PCOD, tubal disease, uterine anomalies, fibroids and adenomyosis, women with recurrent pregnancy loss due to known genetic cause, chromosomal abnormalities, APLA, uncontrolled DM, thyroid dysfunction, cervical incompetence, known immunological causes, structural and functional abnormalities in uterus will be excluded from the study.
Outcomes
Primary Outcomes
To characterize and compare gene expression and perform proteomic profiles to identify and quantify proteins in the biological samples of patients with unexplained infertility and unexplained recurrent pregnancy loss compared to fertile women.
Time Frame: To characterize and compare gene expression and perform proteomic profiles to identify and quantify proteins in the biological samples of patients with unexplained infertility and unexplained recurrent pregnancy loss compared to fertile women in a period of 5 years
Secondary Outcomes
- To integrate gene expression and proteomic data to identify potential molecular pathways or networks that are dysregulated in patients with unexplained infertility and unexplained recurrent pregnancy loss.(To explore the functional implications of identified biomarkers or pathways in reproductive physiology and their potential impact on infertility and pregnancy loss.)
Investigators
Dr S Rajapriya
Madras medical college