| CTRI Number |
CTRI/2025/08/093734 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Serum Antimullerian hormone - a potential marker in blood for identifying women with multiple cystic conditions in the ovary among the regional population |
|
Scientific Title of Study
|
Serum AMH level- a potential biomarker for diagnosing women with PCOS among regional population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Grace Mano R |
| Designation |
PG Register |
| Affiliation |
Sandhya Hospital |
| Address |
No. 565, Phase-I, Sathuvacheri, Vellore - 632009.
Vellore
TAMIL NADU
632009
India |
| Phone |
9865199715 |
| Fax |
|
| Email |
drgracemohan7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandhya Babu |
| Designation |
Director and Senior Consultant |
| Affiliation |
Sandhya Hospital |
| Address |
No. 565, Phase-I, Sathuvacheri, Vellore, TamilNadu, India- 632009.
Vellore
TAMIL NADU
632009
India |
| Phone |
9865199715 |
| Fax |
|
| Email |
drgracemohan7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Grace ManoR |
| Designation |
PG Register |
| Affiliation |
Sandhya Hospital |
| Address |
No. 565, Phase-I, Sathuvacheri, Vellore, TamilNadu, India- 632009.
Vellore
TAMIL NADU
632009
India |
| Phone |
9865199715 |
| Fax |
|
| Email |
drgracemohan7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sandhya Hospital
No. 565, Phase-I, Sathuvacheri, Vellore, TamilNadu, India - 632009. |
|
|
Primary Sponsor
|
| Name |
Dr Sandhya Babu |
| Address |
No. 565, Phase-I, Sathuvacheri, Vellore, TamilNadu, India- 632009. |
| Type of Sponsor |
Other [self] |
|
|
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 GRACE MANO R |
Sandhya Hospital |
Room No 1, Department of Obstetrics and Gynaecology, No. 565, Phase-I, Sathuvacheri, Vellore - 632009
Vellore
TAMIL NADU |
9865199715
drgracemohan7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KHIHS Ethics Committee Clearance |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women fulfilling Rotterdam’s criteria at or above 20 years of age |
|
| ExclusionCriteria |
| Details |
- Women who underwent any gynaecological procedure (ovarian drilling, cystectomy, etc.)
- Women who are already on management for PCOS, like ovarian drilling, infertility treatment, etc.
- Women with other gynaecological complaints like adenomyosis, fibroid or severe endometriosis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum AMH level- a diagnostic tool in diagnosing PCOS |
12 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Serum AMH levels with or without hirsutism
To compare Serum AMH levels with normal and abnormal sonological findings
To predict Serum testosterone level among PCOS
|
12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="137"
Sample Size from India="137"
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)
|
15/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Polycystic
ovary syndrome (PCOS) is the most common endocrine disorder among women in the age group 15 to 45 years. The prevalence of this syndrome
ranges from 4% to 22.5% depending on ethnicity, increasing up to
52% among South Asian women. PCOS is
morphologically defined as the presence of more follicles, especially in small
preantral and antral follicles of size up to 8mm, which are actually
the source of serum AMH. Due to mitotic arrest, the follicles keep on secreting
the hormone, which in turn reflects the condition. Serum AMH can be a reliable,
non-invasive, and affordable test that aids us in diagnosing PCOS, which helps
in planning for further management of infertility. AMH is more reliable
than antral follicular count from ultrasonography as AMH is a reflection
of all the follicles in active and AFC is not superior to AMH. Our study mainly aims in detecting the serum AMH level pertaining to the regional population to predict PCOS among infertile population. |