| CTRI Number |
CTRI/2024/03/064893 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of combination of clomiphene citrate and Letrozole in infertile patients with PCOS |
|
Scientific Title of Study
|
An interventional trial to see the effect of combination of clomiphene citrate and letrozole in infertile women with polycystic ovarian syndrome not responding to either clomiphene citrate or letrozole used as single drug. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shavina Bansal |
| Designation |
Fellow (reproductive endocrinology and infertility) |
| Affiliation |
Post Grauate Institute of medical educationand research |
| Address |
New OPD, second floor, Room no 2046, PGIMER campus, sector 12 Chandigarh
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9465842261 |
| Fax |
|
| Email |
shavinabansal888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shalini Gainder |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Nehru Hospital, second floor Gyane office room no. 10
sector 12
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9465842261 |
| Fax |
|
| Email |
sgainder@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shavina Bansal |
| Designation |
Fellow |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
New OPD room no.2046 PGIMER campus sector 12 Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9465842261 |
| Fax |
|
| Email |
shavinabansal888@gmail.com |
|
|
Source of Monetary or Material Support
|
| New OPD, second floor, Room No. 2046, Post Graduate Institute of Medical Education and Research, Chandigarh
Pin code: 160012
India |
|
|
Primary Sponsor
|
| Name |
Post graduate institute of medical sciences and research |
| Address |
Sector 12
Chandigarh |
| 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 |
| Dr Shavina Bansal |
Post Graduate Institute Of Medical eduation and research |
Obstetrics and Gynaecology department second floor room no 2046
Chandigarh
CHANDIGARH |
9877268674
shavinabansal888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, (Intramural), PGIMER CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N970||Female infertility associated withanovulation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
clomiphene citrate and letrozole |
clomiphene citrate 100 mg and letrozole 2.5 mg
will be given for one menstrual cycle (one month) |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients with PCOS not responding to either clomiphene citrate 100 mg or letrzole 2.5 mg |
|
| ExclusionCriteria |
| Details |
Hypothyroidism
Hyperthyroidism
Hyperprolactinemia
Male factor infertility
Tubal factor infertility
Uncontrolled Diabetes, History of DVT, liver disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ovulation will be assessed as primary outcome |
Will be assessed on day 21 or after 7 days of dominant follicle formation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Endometrial thickness
Number of follicles
Pregnancy rate
Multiple pregnancy rate
OHSS
Any side effects
|
between day 11 TO 18 Endometrial thickness & number of follicles
Pregnacy rate after missed periods
OHSS & any side effect throughout cycle
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="4"
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
|
Patients will be approached for enrollment after checking inclusion and exclusion criteria. Recruitment will be done after taking consent. Trial drugs given in combination from day 2-5 of cycle for 5 days. serial transvaginal ultrasound will be done from day 11 to 18 to see follicle development, endometrial thickness and number of follicles. day 21 serum progesterone or TVS will be done to confirm ovulation. patients advised to follow up on day 2 or 3 of next cycle or if overdue after 1 week pregnancy will be checked by urinary hCG TVS will be dne to see number of sacs and site of pregnancy
|