| CTRI Number |
CTRI/2024/10/074977 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomised Control study : Clomiphene Citrate vs Tamoxifen for Ovulation in Anovulatory infertile women |
|
Scientific Title of Study
|
A RANDOMIZED CONTROL TRIAL TO COMPARE EFFECTIVENESS OF CLOMIPHENE CITRATE VS TAMOXIFEN IN INDUCTION OF OVULATION IN ANOVULATORY INFERTILE WOMEN |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Santhosh |
| Designation |
Postgraduate student |
| Affiliation |
Karnataka Medical College and Research Institute Vidyanagar Hubballi |
| Address |
Department of OBG Karnataka Medical College and Research Institute Vidyanagar
Hubballi 580021
Dharwad
Karnataka
India
Dharwad
KARNATAKA
580021
India |
| Phone |
8722142934 |
| Fax |
|
| Email |
p.santoshsantu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogindra M Kabadi |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Medical College and Research Institute Vidyanagar Hubballi |
| Address |
Department of OBG Karnataka Medical College and Research Institute Vidyanagar
Hubballi 580021
Dharwad
Karnataka
India
Dharwad
KARNATAKA
580021
India |
| Phone |
9448210579 |
| Fax |
|
| Email |
omkabadi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Santhosh |
| Designation |
Postgraduate student |
| Affiliation |
Karnataka Medical College and Research Institute Hubballi |
| Address |
Department of OBG Karnataka Medical College and Research Institute Vidyanagar
Hubballi 580021
Dharwad
Karnataka
India
Dharwad
KARNATAKA
580021
India |
| Phone |
8722142934 |
| Fax |
|
| Email |
p.santoshsantu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of OBG Karnataka Medical College and Research Institute Vidyanagar
Hubballi 580021
Dharwad
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Dr P Santhosh |
| Address |
Department of OBG Karnataka Medical College and Research Institute Vidyanagar
Hubballi 580021
Dharwad
Karnataka
India |
| 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 P SANTHOSH |
Karnataka Medical College and Research Institute Hubballi |
OPD Room Number 8 Department of Obstetrics And Gynecology
Dharwad
KARNATAKA |
8722142934
p.santoshsantu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences Hubballi Ethics Committee |
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 |
Administration of Tablet Tamoxifen |
Administration of Tablet Tamoxifen 20mg per orally from Day 2 of menstrual cycle till day 7 of cycle
Dose is escalated to 40mg and 80 mg in subsequent menstrual cycles for non responders |
| Intervention |
Administration of Tablet Clomiphene Citrate |
Administration of Tablet Clomiphene Citrate 50mg per orally from Day 2 of menstrual cycle till day 7 of cycle
Dose is escalated to 100mg and 150 mg in subsequent menstrual cycles for non responders |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Age: 18 - 35 years.
2. Body mass index (BMI): 18 - 30 kg/m2.
3. Patients with normogonadotropichypogonadism (WHO type 2).
4. Normal semen analysis of the husband.
5. Normal serum Prolactin
6.Consenting to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Thyroid dysfunction, active liver diseases.
2. Local diseases as endometriosis, ovarian tumors, hydro- or pyosalpinx etc.
3. Patients with previous history of Ovulation induction.
4. Patients with previous history of ovarian drilling.
5.Any Medical complications
6.Any Obstetrical complications
7. Any contraindication for Tab Clomiphene citrate or Tab Tamoxifen.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of ovulation |
Follicular scan from Day 11 of menstrual cycle till Day14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Estimation of Endometrial thickness
2 Incidence of Pregnancy
3 Outcome of Pregnancy |
1 Estimation of Endometrial thickness from Day 11 to Day 14 of menstrual cycle
2 Urine Pregnancy Test on 28 day of menstrual cycle
3 Outcome of Pregnancy at 14 weeks of gestation |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/10/2024 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
In this study participants are randomized into two groups Clomiphene Citrate CC or Tamoxifen TX
Cycle 1 Group CC receives Clomiphene 50 mg daily from Day2 to Day7 Follicle study is done from Day10 until ovulation Non-responders move to Cycle 2 with increased doses Group TX receives Tamoxifen 20 mg daily from Day2 to Day7 with the same monitoring process
Cycle 2 CC non-responders from Cycle 1 receive Clomiphene 100 mg TX non-responders receive Tamoxifen 40 mg
Cycle 3 CC non-responders from Cycle 2 receive Clomiphene 150 mg TX non-responders receive Tamoxifen 80 mg
For both groups hCG trigger is given when the dominant follicle reaches 18 to 20 mm and outcome of pregnancy is studied |