| CTRI Number |
CTRI/2023/06/054361 [Registered on: 23/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
descriptive obsevational study |
| Study Design |
Other |
|
Public Title of Study
|
Sperm that have been washed and concentrated are placed directly in your uterus around the time your ovary releases one or more eggs to be fertilized,results in pregnancy.
|
|
Scientific Title of Study
|
EFFICACY OF INTRAUTERINE INSEMINATION IN THE MANAGEMENT OF INFERTILITY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KOMATINENI NANDINI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
vamc medical college and rohilkhand hospital. |
| Address |
varun arjun medical college and rohilkhand hospital,NH 24
girls resident hostel,room no 34
vidyanagar3/7,kakathiya road, guntur, Andhrapradesh
522007
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
07259149656 |
| Fax |
|
| Email |
nandinik1117@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRKGPAUL |
| Designation |
PROFESSOR |
| Affiliation |
vamc medical college and rohilkhand hospital. |
| Address |
varun arjun medical college and rohilkhand hospital,NH 24,banthra,shahjahanpur.
varun arjun medical college and rohilkhand hospital,NH 24,banthra,shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8009033918 |
| Fax |
|
| Email |
obsgynec123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KOMATINENI NANDINI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
vamc medical college and rohilkhand hospital. |
| Address |
varun arjun medical college and rohilkhand hospital,NH 24
girls resident hostel,room no 34
vidyanagar3/7,kakathiya road, guntur, Andhrapradesh
522007
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
07259149656 |
| Fax |
|
| Email |
nandinik1117@gmail.com |
|
|
Source of Monetary or Material Support
|
| varun arjun medical college and rohilkhand hospital |
|
|
Primary Sponsor
|
| Name |
komatineni nandini |
| Address |
girls resident hostel, room no 34,varun arjun medical college and rohilkhand hospital,banthra,shahjahanpur,242307 |
| 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 |
| nandini |
varun arjun medical college and rohilkhand hospital |
obstetrics and gynecology department,first floor.
Shahjahanpur
UTTAR PRADESH |
07259149656
nandinik1117@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institution ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy female fertile volunteers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
having unexplained infertility
2) being infertile for at least one year after trying to become pregnant
3) undergoing IUI for the first time.
4) morphology of sperm should be normal.
5)mobility of sperm should be normal.
|
|
| ExclusionCriteria |
| Details |
) endocrine disorders such as thyroid or diabetes mellitus
2) history of IUI,
3) presence of four or more dominan follicles in the ultrasound imaging before hCG injection, and
4) not having at least two follicles ≥ 18 mm on the days of hCG injection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| livebirth resulting from conception within 4 months after randomization |
The IUI procedure itself takes just two minutes . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menstruation |
1 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/07/2023 |
| 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="5"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IUI is one of the most commonly performed treatments for infertile or sub-fertile patients with male factor and consists of instrumental introduction of processed sperm into the uterus via the cervix to deliver motile sperm to the fallopian tubes around ovulation time. In this procedure the sperm sample is centrifuged, washed and kept in the incubator for capacitation prior to insemination into the uterine cavity. This treatment is used for women with patent tubes and considered the most cost-effective initial treatment for unexplained and moderate male factor infertility. IUI in combination with controlled ovarian hyperstimulation (COH) results in acceptable pregnancy rates per cycle however the overall reported success rates of IUI are variable and ranges from 5-70%. Female age is the most important predictor of IUI success since age has negative impact on ovarian reserve and oocyte quality. Achieving maximum pregnancy rate following IUI-COH requires a balance between an optimal number of follicles, risk of ovarian hyper-stimulation, and multiple pregnancies. In patients with a large number of follicles growing, conversion from IUI to IVF, avoids cancellation of the cycle and lowers the risk of high order multiple pregnancy. AIMS AND OBJECTIVESAimsEfficacy of intrauterine insemination in the management of infertility.Objectives 1. Show the efficacy of IUI in the treatment of infertility. 2. To compare the results of couples undergoing IUI with those adopting timed intercourse but using the same stimulation protocol. |