| CTRI Number |
CTRI/2024/03/064725 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In infertile patient ovulation induction is done by using hormones (clomiphene citrate) compared with hormones with gonodotrpins( used for enhancement of ovulation) and proceeds with artificial insemination. |
|
Scientific Title of Study
|
“Comparison of clomiphene citrate
with clomiphene citrate and gonadotropins in women with unexplained infertility undergoing
intrauterine insemination – A Randomized control 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 |
Subashree |
| Designation |
postgraduate |
| Affiliation |
sri manakula vianayagar medical college |
| Address |
No 61 , veerapachariya Street, Jothi nagar, ok palayam, mudaliarpet.
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9003878935 |
| Fax |
|
| Email |
subashree0723@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJayasree |
| Designation |
PROFESSOR |
| Affiliation |
sri manakula vianayagar medical college |
| Address |
No 68, department of obstetrics and gynaecology
sri manakula vinayagar medical college and hospital kalitheerthalkuppam madagadipet puducherry 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9443769196 |
| Fax |
|
| Email |
obg.jayasreem@smvmch.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrJayasree |
| Designation |
PROFESSOR |
| Affiliation |
sri manakula vianayagar medical college |
| Address |
sri manakula vinayagar medical college and hospital kalitheerthalkuppam madagadipet puducherry 605107
sri manakula vinayagar medical college and hospital kalitheerthalkuppam,madagadipet puducherry 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9443769196 |
| Fax |
|
| Email |
obg.jayasreem@smvmch.ac.in |
|
|
Source of Monetary or Material Support
|
| Subashree
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE
Kalitheerthalkuppam, Puducherry
Kalitheerthalkuppam
Puducherry |
|
|
Primary Sponsor
|
| Name |
Sri Manukula Vinayagar Medical College |
| Address |
SMVMCH, MADAGADIPET, KALITHEERTHALKUPPAM,PUDUCHERRY
605107 |
| 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 |
| SUBASHREE |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF OBSTETRICS AND GYNECCOLOGY ROOM NO 68
PONDICHERRY
Pondicherry
PONDICHERRY |
9003878935
SUBASHREE0723@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
clomiphene citrate |
Participants will receive clomiphene citrate 100mg from day 2 of the menstrual cycle for 5 days. |
| Intervention |
CLOMIPHENE CITRATE AMD GONODOTROPINS |
patients will receive Clomiphene citrate 100 mg from day 3 of the menstrual cycle for 5 days followed by human menopausal gonadotropins (HMG) 75 IU from day 8 of the menstrual cycle till the follicle reaches 18mm size |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age between 18 – 40 years
- Unexplained infertility for more than 2 years
- Normal ovulation proved by mid luteal serum progesterone level >5 ng/ml,
- Patent fallopian tubes confirmed by hysterosalpingography or laparoscopy or saline
infusion sonography
- Normal semen analysis according to the modified World Health Organization (WHO)
criteria
- Normal hormonal profile (FSH, LH, prolactin and TSH) in the early follicular phase. |
|
| ExclusionCriteria |
| Details |
Age >40 years
- Any cause of infertility male factor, tubal or ovaria
- Any contraindication for used drugs
- Women with co-morbidities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcomes will be the number and size of follicles in each ovary |
8 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| THE SECONDARY OUTCOME WILL BE POSITIVE PREGNANCY TEST |
1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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, Time to conceive and cost effectiveness will improve in women with unexplained infertility if it is proved that sequential treatment is better than oral agents alone for ovulation induction. |