| CTRI Number |
CTRI/2025/04/083878 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study will help in finding the pregnancy rate in a single ovulation induction cycle using a drug letrozole among PCOS women with or without prior drug induced bleed. Thereby finding out the extent to which the prior bleed affecting the ovulation rate,pregnancy rate and endometrial thickness. |
|
Scientific Title of Study
|
Conception in single ovulation induction cycle using letrozole among PCOS women with and without prior withdrawal bleed – A randomized controlled trial. |
| 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 Naveena Sri L A |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, pondicherry |
| Address |
Junior Resident
July 2024 batch
Department of Obstetrics and Gynaecology
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8220899257 |
| Fax |
|
| Email |
drarulnaveena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujatha Venkatraman |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, pondicherry |
| Address |
Department of Obstetrics and Gynaecology
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7598500890 |
| Fax |
|
| Email |
drsujatharaman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujatha Venkatraman |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research, pondicherry |
| Address |
Department of Obstetrics and Gynaecology
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7598500890 |
| Fax |
|
| Email |
drsujatharaman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research, pondicherry |
| 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 NAVEENA SRI L A |
Jawaharlal Institute of Postgraduate Medical Education and Research |
ROOM NO 313
BLACKWELL OLD HOSTEL
WOMEN AND CHILD HEALTH BLOCK
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY
Pondicherry
PONDICHERRY |
8220899257
drarulnaveena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional Ethics committee for interventional studies,JIPMER,Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy and fit participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anovulatory PCOS women undergoing ovulation induction using letrozole with prior MPA withdrawal bleed |
MPA 10 mg daily for 10 days – from day 2 of withdrawal bleeding to start T. letrozole of 5mg OD for 5 days. |
| Intervention |
Anovulatory PCOS women undergoing ovulation induction using letrozole without prior MPA withdrawal bleed. |
On the day of enrollment we start letrozole 5 mg OD for 5 days (assigned day 2). |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women diagnosed with PCOS by Rotterdam criteria and not resumed periods after 45 days or women who bleed only with MPA withdrawal
Women between age 20 and 40 years
Endometrial thickness of less than 7 mm
All follicles in ovary should be measuring less than 10 mm |
|
| ExclusionCriteria |
| Details |
Women with functional ovarian cyst
Known case of bilateral tubal block / hydrosalphinx
Morbid obesity of BMI more than 40kg/m2
Severe male factor infertility |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the conception rate (Urine pregnancy test positive after ovulation induction) in a single ovulation induction cycle among anovulatory PCOS women using letrozole with and without prior MPA-induced withdrawal bleed |
conception rate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study ovulation rate & endometrial thickness in a single ovulation induction cycle among anovulatory PCOS women using letrozole with & without prior MPA-induced withdrawal bleed |
AT BASELINE(DAY 2 OF MENSES),DAY 11/12 OF MENSES,4 WEEKS AND 8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/04/2025 |
| 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="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
|
about to start the study
|