| CTRI Number |
CTRI/2025/10/096281 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
genetic workup and protein markers in patients with difficulty in getting pregnant and in patients with repeated abortions in comparison to fertile patients |
|
Scientific Title of Study
|
Gene expression and proteomic profiles in patients with unexplained recurrent pregnancy loss and unexplained infertility versus fertile controls. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Rajapriya |
| Designation |
Assistant Professor |
| Affiliation |
Madras medical college |
| Address |
Institute of Obstetrics and gynaecology, pantheon road, egmore, chennai-8
Institute of obstetrics and gynaecology, egmore, chennai - 8.
Chennai
TAMIL NADU
600008
India |
| Phone |
9791230792 |
| Fax |
|
| Email |
siva.rajababa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Rajapriya |
| Designation |
Assistant Professor |
| Affiliation |
Madras medical college |
| Address |
Institute of obstetrics and gynaecology, Madras medical college, pantheon road, egmore, chennai - 8
Chennai
TAMIL NADU
600008
India |
| Phone |
9791230792 |
| Fax |
|
| Email |
siva.rajababa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Rajapriya |
| Designation |
Assistant Professor |
| Affiliation |
Madras medical college |
| Address |
Institute of obstetrics and gynaecology,pantheon road,egmore, chennai-8.
Chennai
TAMIL NADU
600008
India |
| Phone |
9791230792 |
| Fax |
|
| Email |
siva.rajababa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian council of medical research, New Delhi, India |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
ICMR, Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Rajapriya |
Institute of obstetrics and gynaecology, Madras medical college, chennai |
Centre of fertility and assisted reproduction(CFAR), GYnaecology building, Ground floor.
Chennai
TAMIL NADU |
09791230792
siva.rajababa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Madras medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Unexplained infertility, recurrent pregnancy loss and normal fertile women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
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 Outcome
|
| Outcome |
TimePoints |
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.
To evaluate the potential for targeted therapeutic approaches or interventions based on the findings of gene expression and proteomic analysis.
( BCL6, HOXA10, MUC1, IL6, TNF alpha, LIF,VEGF) |
day 21 of menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |