| CTRI Number |
CTRI/2024/07/070262 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of effects of Clomiphene citrate and Letrozole on uterine body in infertility patients during ovulation induction using USSR |
|
Scientific Title of Study
|
Comparison of Clomiphene citrate and Letrozole using modified Uterine scoring system for reproduction during cycles of ovulation induction : A double blinded Randomised Control 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 |
Pragati Sampanna |
| Designation |
Junior Resident |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Obstetrics and Gynecology
AIIMS PATNA
Phulwarisharif
Patna
Bihar
Patna
BIHAR
801507
India |
| Phone |
7978265361 |
| Fax |
|
| Email |
pragati.sampanna98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indira Prasad |
| Designation |
Additional Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Obstetrics and Gynecology
AIIMS PATNA
Phulwarisharif
Patna
Bihar
Patna
BIHAR
801507
India |
| Phone |
8860033085 |
| Fax |
|
| Email |
indiralh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pragati Sampanna |
| Designation |
Junior Resident |
| Affiliation |
AIIMS PATNA |
| Address |
Department of Obstetrics and Gynecology
AIIMS PATNA
Phulwarisharif
Patna
Bihar
BIHAR
801507
India |
| Phone |
7978265361 |
| Fax |
|
| Email |
pragati.sampanna98@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS PATNA
Phulwarisharif
Patna
Bihar 801507
INDIA |
|
|
Primary Sponsor
|
| Name |
AIIMS PATNA |
| Address |
AIIMS PATNA
Phulwarisharif
Patna
Bihar 801507 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Pragati Sampanna |
AIIMS PATNA |
Room no. 242
2nd floor, OPD block
Department of Obstetrics and Gynecology
AIIMS PATNA
Phulwarisharif
Patna
Bihar 801507
Patna
BIHAR |
7978265361
pragati.sampanna98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Inferitility |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clomiphene Citrate |
50mg
once a day orally
From day 2 to day 6 of menstrual cycle |
| Comparator Agent |
Letrozole |
2.5 mg
once a day orally
from day 2 to day 6 of menstrual cycle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Age- 18-40 years
2. BMI- 18-30 kg/m2
3. Normal TSH, Prolactin
4. Patent fallopian tubes |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years or more than 40 years
2. Male factor infertility |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Endometrial thickness and morphology and vascularity |
day 13 or 15 of menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Myometrial echogenicity and blood flow |
day 13 or 15 of menstrual cycle |
| Uterine artery PI, end diastolic flow |
day 13 or 15 of menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/07/2024 |
| 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
|
Primary purpose of the study is to compare the effects of Clomiphene citrate and Letrozole on the uterine body during cycles of ovulation induction. Clomiphene Citrate and Letrozole are being used for ovulation induction for a long time. They have been extensively compared to find the most effective drug with least adverse effect on uterus. There have been numerous studies comparing number of follicles stimulated by these drugs, their effect on endometrial thickness, their associated beneficial and adverse effects. But no study has been found in literature to the best of our knowledge about their comprehensive effect on the entire uterine body. Hence, we aim to apply an objective scoring system i.e. Uterine Scoring System for Reproduction to compare the effects of these drugs. This scoring system includes the following aspects- endometrial thickness, morphology, vascularity, myometrial echogenicity and blood flow and uterine artery doppler thereby giving us a complete idea about the drug action and its effect on uterus.
|