| CTRI Number |
CTRI/2022/01/039450 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
14/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Letrozole alone with Letrozole and HCG on pregnancy rates in PCOS women with anovulatory infertility : A randomised controlled trial |
|
Scientific Title of Study
|
Comparison of Letrozole alone with Letrozole and HCG on pregnancy rate in pcos women with anovulatory infertility : A randomised 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 |
Neeraj |
| Designation |
Post Graduate |
| Affiliation |
LHMC |
| Address |
Gynaecology OPD room no 12 LHMC
Gynaecology office New building ground floor
Central
DELHI
110001
India |
| Phone |
9654072706 |
| Fax |
|
| Email |
neerajjindal62211@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manju Puri |
| Designation |
Director professor |
| Affiliation |
LHMC |
| Address |
Gynaecology OPD Room no 12 LHMC
Central
DELHI
110001
India |
| Phone |
9654072706 |
| Fax |
|
| Email |
drmanjupuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeraj |
| Designation |
Post Graduate |
| Affiliation |
LHMC |
| Address |
Room no 208 RMO A hostel LHMC
Central
DELHI
110001
India |
| Phone |
9654072706 |
| Fax |
|
| Email |
neerajjindal62211@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College ,DIZ area, Connaught place, New Delhi |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical college |
| Address |
Shaheed Bhagat Singh Marg , DIZ area, Connaught Place, New Delhi |
| 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 |
| Neeraj |
Lady Hardinge Medical College |
OPD Room 12 Obstetrics and Gynaecology , LHMC
Central
DELHI |
9654072706
neerajjindal62211@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lady Hardinge Medical College and Associated Hospitals , New Delhi |
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 |
| Comparator Agent |
Letrozole |
Tablet letrozole two and half mg from day 3 of menses for 5 days |
| Intervention |
Letrozole and HCG
Injection HCG five thousand IU im given when follicle diameter reached more than 18mm along with tab Letrozole |
Injection HCG five thousand IU im given when follicle diameter reached more than 18mm along with tab Letrozole.
it will be studied for 3 cycles. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Anovulatory Infertile PCOS women in age group 20 -35 years. |
|
| ExclusionCriteria |
| Details |
S.FSH levels > 10 IU/L
Other associated causes of female infertilty such as tubal factor or male factor
Women with history of ovarian surgery , ovarian tumor , pelvic adhesions or endometriosis. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of women with positive urinary pregnancy test in each group when they are overdue by 1 week from expected date of menses |
when they are overdue by 1 week from expected date of menses |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of women with USG documented live pregnancy in each group after two weeks overdue from expected date of menses.
Comparison of mean duration of luteal phase in both groups.
Comparison of D21 mean serum progesterone levels in both groups.
|
Not applicable as it will depend on when the patient is getting periods |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
15/01/2022 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Comparison of letrozole alone with letrozole and HCG on pregnancy rates in PCOS women with anovulatory infertility : A randomised controlled trial Sample size : 75 divided in two groups
one group was given T. letrozole two and half mg and other was given injection HCG 5000 IU im with T.Letrozole
T. Letrozole was given as two and half mg starting from day 3 of menses for 5 days and injection HCG was given to other group when follicle diameter reached more thanor equal to 18mm.
|