| CTRI Number |
CTRI/2024/11/076578 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
24-Hour Semen Survival Rate Post-IUI for Pregnancy Outcomes |
|
Scientific Title of Study
|
24 hour semen survival rate post intrauterine: A propective observational study evaluating is predictive value for pregnancy outcomes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajeshkumar Anandaraj |
| Designation |
Senior Embryologist |
| Affiliation |
A4 Hospital and Fertility centre |
| Address |
Embryology Department
A4 Hospital and Fertility centre
87 Arcot road , virugambakkam,
Chennai
Chennai
TAMIL NADU
600092
India |
| Phone |
9704555302 |
| Fax |
|
| Email |
labmanager@a4fertility.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajeshkumar Anandaraj |
| Designation |
Senior Embryologist |
| Affiliation |
Department of Embryology |
| Address |
Embryology Department
A4 Hospital and Fertility centre
87 Arcot road , virugambakkam,
Chennai
Chennai
TAMIL NADU
600092
India |
| Phone |
9704555302 |
| Fax |
|
| Email |
labmanager@a4fertility.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajeshkumar Anandaraj |
| Designation |
Embryologist |
| Affiliation |
Department of Embryology |
| Address |
Embryology Department
A4 Hospital and Fertility centre
87 Arcot road , virugambakkam,
Chennai
Chennai
TAMIL NADU
600092
India |
| Phone |
9704555302 |
| Fax |
|
| Email |
labmanager@a4fertility.com |
|
|
Source of Monetary or Material Support
|
| A4 Hospital and Fertility centre Chennai |
|
|
Primary Sponsor
|
| Name |
A.Rajesh kumar |
| Address |
A4 fertility centre, Virugambakkam,Chennai |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| ARajesh Kumar |
A4 Hospital and Fertility centre |
Department of Embryology A4 Hospital and Fertility centre
87 Arcot road , virugampakkam
Chennai
TAMIL NADU |
9704555302
labmanager@a4fertility.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A4 Hospital - instituitional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N469||Male infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Day(s) |
| Age To |
50.00 Day(s) |
| Gender |
Female |
| Details |
Dominant Follicle greater than or equal to 1
Sperm count greater than 5 million/ml
Density gradient method for sperm preparation.
Freshly ejaculated semen sample
Bilateral Patent tubes
Endometrium greater than 7mm
|
|
| ExclusionCriteria |
| Details |
Sperm count less than 5mill/ml
Frozen semen samples
IUI difficult cannulation
Block in fallopian tube
Endometrium less than 7 mm
Endometriosis
Fibroids in the cavity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pregnancy rate
|
8 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/11/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Female partner were stimulated with minimal stimulation. Scanning were done by day by day. After reaching 18mm size of follicular size trigger were given and after 36 hrs IUI were planned. After 36 hrs of trigger the semen sample was collected and processed with density gradient media. The processed semen sample was injected into the the uterus and the remaining sample were kept with HEPES media for 24hrs and observe the survival rate of sperms. After 15 days analyse the outcome compare with 24 hrs survival. |