| CTRI Number |
CTRI/2024/08/072284 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Screening |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Treatment for Raised sperm DNA Fragmentation |
|
Scientific Title of Study
|
EFFECT OF DIFFERENT INTERVENTIONS USED FOR RAISED SPERM DNA FRAGMENTATION INDEX AND THEIR IMPACT ON REPRODUCTIVE OUTCOMES
|
| Trial Acronym |
SDF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ECR/1312/INST/TG2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna Chaitanya Mantravadi |
| Designation |
Scientific Head |
| Affiliation |
Oasis Fertility |
| Address |
Oasis Fertility
Department of Clinical Embryology
3rd floor
Banjarahills Rd no. 2
Next to NATCO building
Hyderabad
Hyderabad TELANGANA 500034 India |
| Phone |
8008812999 |
| Fax |
|
| Email |
krishna@oasisindia.in |
|
Details of Contact Person Scientific Query
|
| Name |
Krishna Chaitanya Mantravadi |
| Designation |
Scientific Head |
| Affiliation |
Oasis Fertility |
| Address |
Oasis Fertility
Department of Clinical Embryology
3rd floor
Banjarahills Rd no. 2
Next to NATCO building
Hyderabad TELANGANA 500034 India |
| Phone |
8008812999 |
| Fax |
|
| Email |
krishna@oasisindia.in |
|
Details of Contact Person Public Query
|
| Name |
Krishna Chaitanya Mantravadi |
| Designation |
Scientific Head |
| Affiliation |
Oasis Fertility |
| Address |
Oasis Fertility
Department of Clinical Embryology
3rd Floor
Banjarahills Rd no. 2
Next To NATCO building
Hyderabad TELANGANA 500034 India |
| Phone |
8008812999 |
| Fax |
|
| Email |
krishna@oasisindia.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Oasis Fertility |
| Address |
8-2-269/3/1/4
SAI NILAYAM
3rd Floor
Room number 101,
NEAR NATCO PHARMA BUILDING
BANJARAHIILS RD 2
HYDERABAD- 500034 |
| 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 |
| Dr Krishna Chaitanya |
Oasis Fertility |
Department of Embryology
3rd Floor
Room number 101
Next to NATCO building
Banjarahills Road No 2 - 500034 Hyderabad TELANGANA |
7337330437
krishna@oasisindia.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Oasis Fertility |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young male infertility subjects are recruited |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DAILY OR FREQUENT EJACULATION |
Subjects would be advised to ejaculate daily for 5-7 days and then a fresh ejaculate of semen is taken for IVF process |
| Intervention |
MAGNETIC ACTIVATED SPERM CELL SORTING (MACS) |
In this intervention semen sample is produced by masturbation and using MACS technique, sperms with good DNA quality are filtered and used for IVF |
| Intervention |
MICROFLUIDICS SPERM SORTING |
In this intervention semen sample is produced by masturbation and using microfluidics chip technique, sperms with good DNA quality are filtered and used for IVF |
| Intervention |
TESTICULAR SPERM ASPIRATION (TESA) |
Patient Is Subjected To Short General Anaesthesia And Testes Is Subjected To Surgical Retrieval Of Sperms Through Fine Needle Aspiration. This Is A Minimally Invasive Surgery And A Day Care Procedure With No Recruitment For Hospitalisation. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Raised sperm DNA fragmentation index beyond 30% |
|
| ExclusionCriteria |
| Details |
VARICOCOELE
ALCOHOL
SMOKING
HIGH BMI |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sperm DNA Fragmentation |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| implantation rates and live birth rates |
4 weeks after embryo transfer procedure and 9months after positive pregnancy test |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2024 |
| Date of Study Completion (India) |
08/10/2025 |
| 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)
|
Not Applicable |
| 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
|
There are many couples who fail to conceive despite the absence of any apparent reasons, which remain undiscovered during complete infertility investigation or even after necessary treatment intervention. Such a condition may be termed as unexplained infertility. Criteria may include normal history and physical examination, adequate and appropriate coital frequency, three normal semen analysis, regular monthly cycles with a luteal phase of 12 days, adequate cervical mucus and normal post-coital test, normal hormone assay and tubal patency (hysterosalphingogram). The reported overall prevalence of unexplained infertility ranges from 6% to 27%. Male factors contribute significantly to unexplained infertility. Male infertility of unknown origin is a condition in which fertility impairment occurs spontaneously or due to an obscure or unknown cause. It includes two categories, unexplained male infertility and idiopathic male infertility. The dividing line between them is semen analysis, which is normal in the unexplained category and abnormal in idiopathic infertility. During the past couple of decades, several new methods for the assessment of human sperm function have been introduced. These relatively newer technologies have helped detect several defects at various stages of sequential events taking place in human fertilization in patients with otherwise unexplained infertility (UNFPA, 2002). After ruling out female infertility factors, erectile problems and coital factors, modern andrology may help to analyze the unexplained male fertility problem on the basis of cellular and sub cellular mechanisms. Furthermore, this analysis may lead to the selection of proper treatment options fitting the needs of patients with unexplained infertility (Agarwal et al., 2011) and failed IVF attempts. |