| CTRI Number |
CTRI/2018/04/013343 [Registered on: 18/04/2018] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to compare the effect of Clomiphene Citrate and Letrozole in infertile patients with Polycystic Ovarian Disease |
|
Scientific Title of Study
|
A Randomized Controlled Trial comparing the effect of Letrozole and Clomiphene Citrate on endometrial development in infertile women with Polycystic Ovarian Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shavina Bansal |
| Designation |
PG Student |
| Affiliation |
AIIMS, JODHPUR |
| Address |
Department of Obs and Gynae, AIIMS hospital, JODHPUR
Basni phase 2 , Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9465842261 |
| Fax |
|
| Email |
ananyasworld888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashank Shekhar |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS, JODHPUR |
| Address |
3rd floor, AIIMS College, Jodhpur
Basni phase 2, Jodhpur , Rjastahan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
08003996917 |
| Fax |
|
| Email |
longshanks28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHAVINA BANSAL |
| Designation |
PG Student |
| Affiliation |
AIIMS, JODHPUR |
| Address |
2nd floor C block , Obs and Gynae department of AIIMS hospital, JODHPUR
BASNI PHASE 2 , JODHPUR RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9465842261 |
| Fax |
|
| Email |
ananyasworld888@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Academics and Research department Jodhpur |
| Address |
Basni phase 2 Jodhpur |
| 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 |
AIIMS, JODHPUR |
AIIMS OPD, 2nd Floor , C block
Jodhpur
RAJASTHAN |
9465842261
ananyasworld888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Infertile women with PCOS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clomiphene citrate and Letrozole |
Clomiphene Citrate (50-150 mg) from day 2 to day 5 x 3 cycles
Letrozole (2.5-7.5 mg)from day 2 to day 5 x 3 cycles |
| Comparator Agent |
Letrozole will be compared with Clomiphene Citrate |
There will be two groups. one will receive Letrozole and other will receive Clomiphene citrate.Effects of both the drugs will be studied on endometrial thickness |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Polycystic ovarian syndrome having infertility for at least 1 year |
|
| ExclusionCriteria |
| Details |
1. Hypothyroidism
2. Hyperprolactinemia
3. Male factor infertility
4. Tubal infertility
5. Females using other medications known to affect reproductive functions ( oral contraceptive pills, GnRH agonists and antagonists, anti-androgens)
6. Medical morbidities ( poorly controlled type 1 or type 2 DM; undiagnosed liver disease; history of deep vein thrombosis; pulmonary embolus; cerebrovascular accident; uncontrolled hypertension; suspected cervical carcinoma, endometrial carcinoma or breast carcinoma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare the endometrial thickness during ovulation induction using Letrozole and clomiphene citrate in infertile women with PCOS
|
Day 11 to day 18 of cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To Compare the ovulation rate
2. To compare the pregnancy rate
|
1. From day 11 to day 18 of cycle
2 after missed periods or menstruation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2018 |
| Date of Study Completion (India) |
11/11/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published in International journal of gynecology and obstetrics in SEPTEMBER 2020 VOLUME 152, ISSUE 3 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response (Others) - baseline characteristics
results
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - email at ananyasworld888@gmail.com
- For how long will this data be available start date provided 20-01-2024 and end date provided 20-09-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
Randomisation followed by Ovulation induction from day 2 to day 6 of cycle then TVS will be done from day 11 to day 18 Injection hCG 5000 IU given when follicle size reach > 18 mm Ovulation will be confirmed by transvaginal sonography Pregnancy- assessed by hCG measurement after missed periods |