| CTRI Number |
CTRI/2024/09/073446 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| 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 two drugs for ovulation in infertile women with decreased reserve- A randomised controlled trial |
|
Scientific Title of Study
|
Comparison of Clomiphene Citrate vs Human Menopausal Gonadotropin for controlled ovarian stimulation in infertile women with decreased ovarian reserve (DOR) - A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragya Kumari |
| Designation |
Post graduate resident |
| Affiliation |
Lady Hardinge Medical College and associated hospitals |
| Address |
ART centre, infertlity unit(division), OPD building, obstetrics and gynaecology department, Lady Hardinge medical college and associated hospitals, Connaught place
New Delhi
DELHI 110001 India
New Delhi
DELHI
110001
India |
| Phone |
9939268195 |
| Fax |
|
| Email |
pragya15698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidhi Chaudhary |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College and associated hospitals |
| Address |
ART centre, infertlity unit(division), OPD building, obstetrics and gynaecology department, Lady Hardinge medical college and associated hospitals, Connaught place
New Delhi
DELHI 110001 India
New Delhi
DELHI
110001
India |
| Phone |
9971073780 |
| Fax |
|
| Email |
drvidh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidhi Chaudhary |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College and associated hospitals |
| Address |
ART centre, infertlity unit(division), OPD building, obstetrics and gynaecology department, Lady Hardinge medical college and associated hospitals, Connaught place
New Delhi
DELHI 110001 India
New Delhi
DELHI
110001
India |
| Phone |
9971073780 |
| Fax |
|
| Email |
drvidh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, Connaught Place, New Delhi 110001, India |
|
|
Primary Sponsor
|
| Name |
Pragya Kumari |
| Address |
Lady Hardinge Medical College and associated hospitals, Connaught Place, New Delhi- 110001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Pragya Kumari |
Lady Hardinge Medical college and Associated hospitals |
Dr Pragya Kumari
Lady Hardinge Medical College and associated hospitals
room number 101,ART centre, infertility unit(division), OPD building, obstetrics and gynecology department, Lady Hardinge medical college and associated hospitals, Connaught place,New Delhi-110001
New Delhi
DELHI |
9939268195
pragya15698@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N978||Female infertility of other origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injectable HMG |
Group B will receive injectable HMG i/m as a step up regimen starting from 75IU/day from day 2-5 of cycle and increasing every 4-7 days till a maximum dose of upto 225 IU. |
| Comparator Agent |
Oral clomiphene citrate |
.Group A will receive oral clomiphene citrate 50mg orally from day 2 to day 6 of menstrual cycle for 3 cycles. If patient does not ovulate in the first cycle then further 2 cycles will be tried with 100mg/day. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Infertile women of decreased ovarian reserve as described by Cohen et al with one or both of the given two criteria and with a normal husband semen analysis
1 AFC less than 7
2 AMH less than 1.1ng/ml |
|
| ExclusionCriteria |
| Details |
1 Blocked fallopian tubes bilaterally
2 Untreated intrauterine polyps
3 Untreated submucosal fibroids indenting the uterine cavity
4 Uterine malformations, intrauterine adhesions
5 Endocrine disorders-abnormal thyroid function, hyperprolactinemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of mean number of dominant follicles formed in women with decreased ovarian reserve following controlled ovarian stimulation with-
1. Clomiphene citrate
2. Gonadotropin |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the following among the 2 drugs-
1.Biochemical pregnancy (as defined by positive Urine Pregnancy Test)
2. Clinical pregnancy (ultrasound documenting gestational sac formation, cardiac activity, crown rump length)
3. OHSS (Ovarian hyperstimulation syndrome)
4. Multiple pregnancy
5. Miscarriage |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- 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 - Proposals should be directed to [pragya15698@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
For women with decreased ovarian reserve, controlled ovarian stimulation is done with drugs like clomiphene citrate, letrozole and injectable HMG, and very less number of studies have been done to establish the superiority of one over the other. In this study, two drugs, clomiphene citrate and injectable HMG will be compared for evaluating the efficacy of controlled ovarian stimulation over 3 cycles in women with decreased ovarian reserve. Concealed allocation by placing in sealed envelopes will be done. Each woman will be assigned one envelope and would be categorised into group A and B .Group A will receive oral clomiphene citrate 50mg orally from day 2 to day 6 of menstrual cycle for 3 cycles. If patient does not ovulate in the first cycle then further 2 cycles will be tried with 100mg/day. Group B will receive injectable HMG i/m as a step up regimen starting from 75IU/day from day 2-5 of cycle and increasing every 4-7 days till a maximum dose of upto 225 IU. Comparison of proportion of mean number of dominant follicles formed during controlled ovulation stimulation among clomiphene citrate and injectable HMG over 3 cycles will be done. Further, biochemical pregnancy as defined by positive UPT, clinical pregnancy confirmed by ultrasound findings, OHSS, multiple pregnancy and miscarriage rates will be compared over the 3 cycles. |