| CTRI Number |
CTRI/2023/01/048854 [Registered on: 10/01/2023] Trial Registered Prospectively |
| Last Modified On: |
09/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Letrozole 2.5 mg or 5.0 mg for Ovulation Induction
in Intrauterine Insemination in case of Unexplained Infertility |
|
Scientific Title of Study
|
Effect of Letrozole 2.5 mg vs 5.0 mg for ovulation induction in case of unexplained infertility in intrauterine insemination - A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Goel |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College , Tanda , Kangra |
| Address |
Department of obstetrics and gynecology ,
Dr Rajendra Prasad Government Medical College , Tanda , Kangra
Department of Obstetric and Gynecology , Tanda
Dr Rajendra Prasad Government Medical College , Tanda , Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9896859060 |
| Fax |
|
| Email |
drnehagoel7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Goel |
| Designation |
Junior Resident |
| Affiliation |
Dr Rajendra Prasad Government Medical College , Tanda , Kangra |
| Address |
Department of obsterics and gynecology ,
Dr Rajendra Prasad Government Medical College , Tanda , Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9896859060 |
| Fax |
|
| Email |
drnehagoel7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Verma |
| Designation |
Professor |
| Affiliation |
Dr Rajendra Prsad Government Medical College , Tanda , Kangra |
| Address |
Department of Obstetrics and Gynecology ,
Dr Rajendra Prasad Government Medical college , Tanda , Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418088340 |
| Fax |
|
| Email |
artiashokverma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynecology ,
Dr Rajendra Prasad Government College , Tanda , Kangra |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Government Medical College , Tanda , Kangra |
| Address |
Department of Obsterics and Gynecology ,
Dr Rajendra Prasad Government Medical College , Tanda , Kangra |
| 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 Neha Goel |
Dr Rajendra Prasad Government Medical College , Tanda , Kangra |
Department of Obstetrics and Gynecology,
OPD No. 12
Kangra
HIMACHAL PRADESH |
9896859060
drnehagoel7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rajendra Prasad Government Medical College , Tanda ,Kangra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Letrozole 2.5 mg vs 5.0 mg |
The drug is to be given orally for 5 days starting from day 3 of the menstrual cycle and is to be given for 4 cycles of intrauterine insemination .
the ovulation rates of the two different doses of this drug is to be compared |
| Intervention |
Ovulation Induction - letrozole 2.5 mg vs 5.0 mg |
Letrozole in a dose of 2.5 mg or 5.0 mg orally is to be given for 5 days starting from day 3 to day 7 of menstrual cycle.
the drug is to be given for 4 cycles of intrauterine insemination . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Unexplained infertility of at least 1 year duration
Normal tubes on Hysterosalpingography
Normal Semen Parameters of husband
|
|
| ExclusionCriteria |
| Details |
Patients with grade 4 endometriosis
Those with untreated endocrinological disorder
Those not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare ovulation rates in two groups |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare pregnancy rates in two groups |
After 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/01/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized controlled trial comparing the ovulation induction rates in two groups each of 30 patients with unexplained infertility undergoing intrautrerine insemination with Letrozole 2.5 mg vs 5.0 mg over 1 year . |