| CTRI Number |
CTRI/2025/01/079121 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Hormone level analysis in venous and menstrual blood |
|
Scientific Title of Study
|
Analysis of Hormonal Biomarkers in Menstrual Blood of Adult Female with Polycystic Ovarian Diseases |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalaiarasi S |
| Designation |
CEO |
| Affiliation |
Thremear Pvt Ltd |
| Address |
Thremear Pvt Ltd, 4/692, L R Avenue, Medavakkam, Chennai - 100
Chennai
TAMIL NADU
600100
India |
| Phone |
9025203460 |
| Fax |
|
| Email |
kalaiarasi@thremear.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalaiarasi S |
| Designation |
CEO |
| Affiliation |
Thremear Pvt Ltd |
| Address |
Thremear Pvt Ltd, 4/692, L R Avenue, Medavakkam, Chennai - 100
Chennai
TAMIL NADU
600100
India |
| Phone |
9025203460 |
| Fax |
|
| Email |
kalaiarasi@thremear.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalaiarasi S |
| Designation |
CEO |
| Affiliation |
Thremear Pvt Ltd |
| Address |
Thremear Pvt Ltd, 4/692, L R Avenue, Medavakkam, Chennai - 100
Chennai
TAMIL NADU
600100
India |
| Phone |
9025203460 |
| Fax |
|
| Email |
kalaiarasi@thremear.com |
|
|
Source of Monetary or Material Support
|
| Source of Monetary support- Thremear Pvt. Ltd. Fund- startup internal funds Pl.No.672, II Cross Street, Sridevi Karumariamman Nagar, Nandampakkam, Kancheepuram, Chennai- 600069, Tamil Nadu, India. |
| The Institute/Hospital the study is conducted provided the infrastructural support for the same-
Chettinad Academy of Research and Education
Rajiv Gandhi Salai, Kelambakkam, Chengalpattu, Chennai - 603 103, Tamil Nadu, India.
|
|
|
Primary Sponsor
|
| Name |
Thremear Private Limited |
| Address |
Pl.No.672, II Cross Street, Sridevi Karumariamman Nagar, Nandampakkam, Kancheepuram, Tamil Nadu- 600069 |
| Type of Sponsor |
Other [Startup] |
|
|
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 Sailatha OBG |
Dr. Sailatha Chettinad Academy of Research and Education |
Chettinad Health City,
Rajiv Gandhi Salai,
Kelambakkam - 603 103,
Chennai,
Tamil Nadu, India.
Chennai
TAMIL NADU |
09500070655
sailatha.ramanujam@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Faculty Research (CARE IHEC-II) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N914||Secondary oligomenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria for cases
1. Women aged between 18 - 55 years
2. Women with irregular menstrual cycles
3. Women with PCOD
4. Menorrhoea |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for controls
1. Pregnant women
2. Women with a history of miscarriage or abortion
3. Women under contraceptive usage
4. Lactating mothers
5. Women with any history of congenital abnormalities of the genito-urinary system
6. Women with Vaginal candidiasis, any infectious or fungal disease
7. Women with uterine fibroids
8. Women who have undergone hysterectomy
Exclusion criteria for cases
1. Menopausal women
2. Women undergoing hormonal replacement therapy
3. Women with Vaginal candidiasis, any infectious or fungal disease
4. Women with uterine fibroids
5. Women who have undergone hysterectomy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical reference value of hormones in the menstrual blood of healthy adults |
8 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hormone levels in menstrual blood
2. Comparison or ratio of hormone levels between menstrual & venous bloods |
7 Weeks
3 Months
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
03/02/2025 |
| 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="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Infertility/Subfertility is a complex disorder associated with significant medical, psychosocial, and economic aspects. Hormonal imbalance is a serious medical health issue with the potential to lead to various other diseases such as infertility, PCOS, ovarian irregularity, hyperandrogenism, cystic ovaries, higher insulin levels, and type 2 diabetes. The prevalence of PCOS in Indian adolescents is around 12.2% according to the Indian Council of Medical Research. An underdiagnosed or over-diagnosed PCOS condition will put the woman at a high risk of serious complications, cause an intake of unnecessary medications, and huge psychological impact. People with regular menstrual cycles and healthy or lower BMI can also develop PCOS. If these conditions are untreated at the right time, it may lead to several comorbidities like diabetes, heart disease, etc. Hormonal such as gonadotropin-releasing hormone (GnRH), insulin, the luteinizing/ follicle-stimulating hormone (LH/FSH) ratio, androgens, estrogens, growth hormones (GH), cortisol, parathyroid hormone (PTH), and calcitonin are disturbed and are used as biomarkers to identify issues related to PCOS. The presence of these biomarkers apart from venous blood is less explored. The present study is designed to explore the presence of hormone biomarkers in menstrual blood correlating to the venous blood in PCOD/PCOS conditions. The aim of the study is to find the presence and quantify the hormonal biomarkers in menstrual blood (non-invasive samples) in PCOD patients. An observational study design is developed with two groups PCOD/PCOS positive group and control group. Venous blood and menstrual blood will be collected and analyzed for the hormone biomarkers using the CLIA method. Statistical analysis involving the relationship and correlation of the hormone biomarkers in the participants will be evaluated and interpreted. Thus analysing these hormone biomarkers will help predict the menstrual health that would allow PCOD/PCOS women and the clinicians to make more precise predictions about the nature and timing of their abnormality and proceed with the early treatment. |