| CTRI Number |
CTRI/2020/06/025536 [Registered on: 02/06/2020] Trial Registered Prospectively |
| Last Modified On: |
26/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of letrozole and clomiphen citrate versus letrozole alone in infertility women |
|
Scientific Title of Study
|
“Effect of combination of letrozole with clomiphene citrate versus letrozole alone on pregnancy rate in subfertile women with polycystic ovarian syndrome: A randomized control trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pruthwiraj Sethi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Room No: 17, 5th Floor, Hospital building, AIIMS,Bhubaneswar At: Sijua,PO:Dumduma, Dist: Khordha Pin: 751019
Associate professor, Dept of O & G, AIIMS, Bhubaneswar, Sijua, Dumduma, Dist: Khordha 751019
Khordha
ORISSA
751019
India |
| Phone |
09438884132 |
| Fax |
|
| Email |
drpruthwiraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pruthwiraj SethiI |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room no:17, 5th floor, Hospital building, AIIMS, Bhubaneswar At: Sijua, po: Dumduma Dist: Khordha
Associate professor, Dept of O & G, AIIMs, Bhubaneswar,Sijua, Dumduma, Dist: Khordha Pin: 751019
Khordha
ORISSA
751019
India |
| Phone |
09438884132 |
| Fax |
|
| Email |
drpruthwiraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pruthwiraj Sethi |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room no:17, 5th floor, Hospital building, AIIMS, Bhubaneswar At: Sijua, po: Dumduma Dist: Khordha
Room no:17, 5th floor, Hospital building, AIIMS, Bhubaneswar At: Sijua, po: Dumduma Dist: Khordha
Khordha
ORISSA
751019
India |
| Phone |
09438884132 |
| Fax |
|
| Email |
drpruthwiraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural grant,Istitute Research Cell, All India Institute of Medical Sciences,Bhubaneswar ,At; Sijua, Po: Dumduma, Dist:Khordha Pin: 751019 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences BHUBANESWAR INTRAMURAL GRANT |
| Address |
Institute Research Cell,AIIMS, Bhubaneswar, At: Sijua,PO; DumdumaDist: Khordha PIN;751019 |
| 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 Pruthwiraj Sethi |
AIIMS Bhubaneswar, Obstetrics and Gynecology Department |
Department of O&G, AIIMS, Bhubaneswar,At: Sijua Po: Dumduma Dist; Khordha, Pin: 751019 ODISHA 751019
Khordha
ORISSA |
9438884132
drpruthwiraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, AIIMS, Bhubaneswar, Odisha |
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 |
| Comparator Agent |
letrozole 2.5 mg |
Comparater group will receive tablet letrozole 2.5 mg daily orally from 2nd day of menstrual cycle. If they do not conceive then same amount of dose will be contiued for three cycle( 3 months) |
| Intervention |
letrozole and clomiphene citrate |
Intervention group will receive tablet letrozole 2.5mg and clomiphene citrate 50 mg daily orally for five days from day two of the menstrual cycle. If patient do not conceive then this dose will be repeated for 3 cycle (3 moths) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women from age of 18-40 years diagnosed with subfertility with PCOS and no other detectable cause of infertility.
Proven patency of at least one fallopian tube.
Sperm count of 15 million/ml and more than 40% motility will be included. |
|
| ExclusionCriteria |
| Details |
Women having other cause of subfertility.
Recent use of hormonal contraception.
Hyperprolactinemia, untreated thyroid disease, uncontrolled diabetes.
Drug allergy or contraindication to letrozole or clomiphene citrate. |
|
|
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 |
| Conception: a positive serum or urinary test of hCG |
1-3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number and size of developing follicle on day 12-14, endometrial thickness on day 12-14, clinical pregnancy: an intrauterine gestational sac, complication related to study medication |
1-3 months |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
05/06/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In reproductive age group, polycystic ovarian syndrome (PCOS) is most common cause of anovlatory subfertility. Therefore the treatment of subfertility in these women is targeted on ovulation induction.Till date various regimen have been tried to improve ovulation rate, pregnancy rate and live birth. Clomiphene citrate is commonly used for induction in women with PCOS. Letrozole is another drug commonly used as ovulation induction agent in women with poly cystic ovarian syndrome.Because letrozole and clomiphene have different mechanism of action we hypothesized that the combination of these two drugsmay result in an increased pregnancy rate over letrozole alone in women with PCOS. Objectives: Estimation of pregnancy rate between two groups and estimation of ovulation rate |