| CTRI Number |
CTRI/2026/03/106989 [Registered on: 27/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of serum AMH levels (a blood test) in predicting successful ovulation (release of egg from ovary) among PCOS women undergoing ovulation induction treatment with tablet LETROZOLE. |
|
Scientific Title of Study
|
Role of Anti-Mullerian hormone (AMH) levels in predicting ovulatory response among PCOS women undergoing ovulation induction with letrozole – A Prospective cohort study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhivani Subburayalu |
| Designation |
Postgraduate Junior Resident, Dept of OBG |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry. |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098446292 |
| Fax |
|
| Email |
su.madhivani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujatha Venkatraman |
| Designation |
AssistantProfessor, Dept of OBG |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry. |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7598500890 |
| Fax |
|
| Email |
drsujatharaman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhivani Subburayalu |
| Designation |
Postgraduate Junior Resident, Dept of OBG |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry. |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098446292 |
| Fax |
|
| Email |
su.madhivani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Research Fund Committee, JIPMER
Puducherry - 605006. |
|
|
Primary Sponsor
|
| Name |
Intramural Research Fund Committee JIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry,
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar,
Puducherry - 605006
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 MADHIVANI S |
JIPMER- Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry |
Department of Obstetrics and Gynaecology, WCH block,JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar,
Puducherry - 605006
Pondicherry
PONDICHERRY |
8098446292
su.madhivani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES, JIPMER, DHR REG. NO. EC/NEW/INST/2020/331 |
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 |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
women diagnosed with PCOS by Rotterdam criteria aged 21-40 years |
|
| ExclusionCriteria |
| Details |
1. Women with functional ovarian cyst
2. Associated endometriotic cyst
3. Smoking
4. Women on Oral contraceptive pills within 3 months
5. Women with history of Ovarian surgery
6. Chemotherapy/ Radiotherapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ovulatory response among PCOS women undergoing ovulation induction with letrozole |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="167"
Sample Size from India="167"
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)
|
08/04/2026 |
| 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="2"
Months="0"
Days="0" |
|
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 is a prospective cohort study titled Role of Anti-Mullerian
hormone levels in predicting ovulatory response among PCOS women
undergoing ovulation induction with letrozole. we conduct this study on women diagnosed with PCOS based on Rotterdam criteria aged 21-40 years seeking fertility treatment in WCH, JIPMER. Baseline infertility investigations including serum AMH levels done followed by ovulation induction with tablet LETROZOLE and assess ovulatory response. the primary objective is To assess the predictive
accuracy of Serum AMH level on detecting Ovulatory response among PCOS women
undergoing ovulation induction with letrozole. The secondary objective is To correlate the dose of
Letrozole lor ovulation induction with Serum AMH level. |