Sperm DNA FragmentationDSBsNCT07621991
Clinical Thresholds of Double-strand Breaks in Sperm's DNA in ART
An observational study of Sperm DNA Fragmentation and Sperm DNA Impact on ART Outcomes, run by Indira IVF Hospital Pvt Ltd at 2 sites in India.
Trial summary
The goal of this prospective observational study is to learn about the impact of double-strand sperm DNA fragmentation (dsSDF) on assisted reproductive technology (ART) outcomes and to derive clinically relevant threshold values for dsSDF and global sperm DNA fragmentation (SDF) in couples undergoing intracytoplasmic… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sperm DNA Fragmentation, Sperm DNA Impact on ART Outcomes
- What is being tested?
- LensHooke X12 Device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 484 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Jun 2026to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population will consist of infertile couples undergoing intracytoplasmic sperm injection (ICSI) at participating tertiary IVF centres in India. Inclusion and exclusion criteria have been defined to establish a relatively homogeneous study population suitable for evaluating the impact of double-strand sperm DNA fragmentation (dsSDF) and global sperm DNA fragmentation (SDF) on assisted reproductive technology (ART) outcomes while minimizing potential confounding factors related to severe male factor infertility, female reproductive pathology, and adjunctive fertility interventions.
Who may be able to join
- Males aged 21-55 years undergoing ICSI treatment for male factor infertility.
- Women with age 21-35 for self-oocyte pickup cycles
- Oocyte donor cycles with recipient age of 21-35 years of age
- Sperm with a minimum total motile sperm count of 2.0 million/mL and a minimum volume of 1.2 mL
- Patients not underwent sperm DNA fragmentation testing
- 2-3 days of abstinence prior to intracytoplasmic sperm injection (ICSI).
Who cannot join
- Severe male factor infertility (azoospermia or severe oligozoospermia; for this study defined as no sperm present or sample with <2 million/ml sperm count)
- Known systemic diseases (e.g., diabetes mellitus).
- Surgically retrieved sperms using testicular sperm aspiration, testicular sperm extraction and percutaneous epididymal sperm aspiration.
- Untreated endometrial or uterine factors or adnexal pathology
- Embryos underwent preimplantation genetic testing for aneuploidy testing.
- Patients with thin endometrium (<7mm)
- Patients opted or underwent donor sperms as the male gamete source.
- Patients underwent antioxidant treatment in last 6 months prior to ICSI treatment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India2 sites
Indira IVF Hospital
Bangalore, Karnataka, 560041
Jishnu PS, MSc, 919645062072, jishnu.ps@indiraivf.in
Shyam Gupta, M.S. (OBGY)
Indira IVF Hospital
Pune, Maharashtra, 411014
Rajesh Bhisade, MSc, 919028034181, rajesh.bhisade@indiraivf.in
Amol Lunkad, M.S. (OBGY)
About this study
Official title: A Prospective Trial Assessing the Impact of Double-strand Breaks on ART Outcomes and Predicting Its Clinical Thresholds
The goal of this prospective observational study is to learn about the impact of double-strand sperm DNA fragmentation (dsSDF) on assisted reproductive technology (ART) outcomes and to derive clinically relevant threshold values for dsSDF and global sperm DNA fragmentation (SDF) in couples undergoing intracytoplasmic sperm injection (ICSI). The main questions it aims to answer are:
- Can clinically relevant threshold values of dsSDF and global SDF predict live birth rates following ICSI?
- Does elevated dsSDF reduce live birth rates following ICSI? Participants undergoing ICSI as part of their routine fertility treatment will provide semen samples for global SDF and dsSDF assessment using the R10 Plus and R11 Plus kits, respectively, analysed using the LensHooke® X12 platform before and after sperm preparation. SDF and dsSDF assessments will be performed both prior to and following sperm washing for each participant. Embryos will be assessed from fertilization through embryo development, and following embryo transfer, participants will be prospectively followed for clinical outcomes ranging from biochemical pregnancy to live birth.
Read the detailed description
This prospective, two-centre observational study is designed to evaluate the impact of double-strand sperm DNA fragmentation (dsSDF) on assisted reproductive technology (ART) outcomes and to derive clinically relevant threshold values for dsSDF and global sperm DNA fragmentation (SDF) in couples undergoing intracytoplasmic sperm injection (ICSI). Although conventional sperm DNA fragmentation assays assess overall DNA damage, they do not differentiate between single- and double-strand DNA breaks. Emerging evidence suggests that dsSDF represents a more severe form of genomic damage with limited oocyte repair potential and may therefore have a greater impact on embryological and reproductive outcomes, particularly live birth.
A total of 484 infertile couples undergoing ICSI treatment at two tertiary IVF centres in India will be prospectively recruited based on predefined eligibility criteria. Semen samples will be collected on the day of ICSI following 2-3 days of sexual abstinence. Global SDF and dsSDF assessments will be performed using the LensHooke® X12 platform with the R10 Plus and R11 Plus kits, respectively. SDF testing will be conducted both before and after sperm preparation to evaluate the impact of sperm washing on DNA fragmentation parameters.
Embryos derived from enrolled participants will be prospectively assessed from fertilization through embryo development. Following embryo transfer, participants will be prospectively followed for clinical outcomes including biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, and live birth.
Receiver operating characteristic (ROC) curve analysis will be used to derive clinically relevant threshold values for dsSDF and global SDF. Multivariable regression analyses will additionally be performed to evaluate the predictive value of dsSDF and global SDF for ART outcomes while adjusting for potential confounding factors. The findings of this study are expected to improve the clinical interpretation of sperm DNA damage assessment and support the integration of dsSDF into individualized reproductive care.
- Being tested
- LensHooke X12 Device
- Keywords
- Sperm DNA fragmentation, Double-strand sperm DNA fragmentation, LensHooke® X12, ntracytoplasmic sperm injection, Live birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LensHooke X12 DeviceDevice
The LensHooke® X12 device is an automated sperm DNA fragmentation assessment platform based on the sperm chromatin dispersion (SCD) principle. In this study, the device will be used to assess global sperm DNA fragmentation (SDF) and double-strand sperm DNA fragmentation (dsSDF) using the R10 Plus and R11 Plus kits, respectively. The platform incorporates automated image acquisition and analysis to minimize operator-dependent variability and standardize sperm DNA fragmentation assessment. Semen samples collected from participants undergoing intracytoplasmic sperm injection (ICSI) will be analysed before and after sperm preparation to evaluate the association between sperm DNA damage parameters and assisted reproductive technology (ART) outcomes.
| Study group | Role | What they receive |
|---|---|---|
| ICSI Couples Undergoing SDF and dsSDF Assessment | Infertile couples undergoing intracytoplasmic sperm injection (ICSI) at participating tertiary IVF centres will be prospectively enrolled based on predefined eligibility criteria. Semen samples collected on the day of ICSI will undergo assessment of global sperm DNA fragmentation (SDF) and double-strand sperm DNA fragmentation (dsSDF) using the LensHooke® X12 platform with the R10 Plus and R11 Plus kits, respectively. SDF assessments will be performed before and after sperm preparation. Receives: Device: LensHooke X12 Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth rate
Live birth will be defined as the delivery of one or more live infants at or beyond 24 weeks of gestation following embryo transfer. Live birth rate will be calculated as the proportion of embryo transfer cycles resulting in at least one live birth.
Measured: 24 weeks post embryo transfer
Secondary outcomes (1)
Clinical Threshold Values for dsSDF and Global SDF
Clinically relevant threshold values for double-strand sperm DNA fragmentation (dsSDF) and global sperm DNA fragmentation (SDF) will be derived using receiver operating characteristic (ROC) curve analysis based on their predictive ability for live birth and other assisted reproductive technology (ART) outcomes. Thresholds will be identified as the values associated with a significant reduction in reproductive outcomes following intracytoplasmic sperm injection (ICSI).
Measured: From fertilization assessment following intracytoplasmic sperm injection (ICSI) until live birth, approximately 18 months after participant enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sperm DNA FragmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indira IVF Hospital Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Bonraybio Co. Ltd., ADVY Chemical Private Limited
- Responsible party
- Principal investigator, Dr Vipin Chandra, Indira IVF Hospital Pvt Ltd
- Investigators
- Vipin Chandra, M.B.B.S., D.G.O., Principal investigator, Indira IVF Hospital Limited, IndiaSandro Esteves, Ph.D., Study director, Androfert Clinic, BrazilNaval Shah, MSc, Study chair, Indira IVF Hospital Limited, IndiaShashank Sanagoudar, M.S. (OBGY), Study chair, Indira IVF Hospital Limited, IndiaDivreena Talwar, MSc, Study chair, Indira IVF Hospital Limited, IndiaJayesh Shinde, MSc, Study chair, Indira IVF Hospital Limited, IndiaVivek Dave, Ph.D., Study chair, Indira IVF Hospital Limited, IndiaSantoshi Kadam, Study chair, ADVY Chemical Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621991
- Sponsor's protocol ID
- IIHL/EMB/PRS_001_2026
- Acronym
- DSBs
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: We will share IPD on request
Publications
Alvarez JG, Garcia-Peiro A, Barros A, Ferraz L, Sousa M, Sakkas D. Double strand DNA breaks in sperm: the bad guy in the crowd. J Assist Reprod Genet. 2023 Apr;40(4):745-751. doi: 10.1007/s10815-023-02748-5. Epub 2023 Feb 24.
PubMed 36823317Agarwal A, Barbarosie C, Ambar R, Finelli R. The Impact of Single- and Double-Strand DNA Breaks in Human Spermatozoa on Assisted Reproduction. Int J Mol Sci. 2020 May 29;21(11):3882. doi: 10.3390/ijms21113882.
PubMed 32485940Wang TE, Lee CI, Huang CC, Tsao HM, Chang HC, Chang LS, Chang TA, Lee MS, Hsu CT. Innovative technology for evaluation of sperm DNA double-strand breaks diagnoses male factor infertility and prevents reproductive failures. Sci Rep. 2023 Nov 3;13(1):18996. doi: 10.1038/s41598-023-46049-4.
PubMed 37923811
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial Assessing the Impact of Double-strand Breaks on ART Outcomes and Predicting Its Clinical Thresholds
- ClinicalTrials.gov ID
- NCT07621991
- Acronym / sponsor ID
- DSBs / IIHL/EMB/PRS_001_2026
- Keywords
- Sperm DNA fragmentation, Double-strand sperm DNA fragmentation, LensHooke® X12, ntracytoplasmic sperm injection, Live birth
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Indira IVF Hospital Pvt LtdUniversity, hospital or other
- Collaborators
- Bonraybio Co. Ltd., ADVY Chemical Private Limited
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective observational study is to learn about the impact of double-strand sperm DNA fragmentation (dsSDF) on assisted reproductive technology (ART) outcomes and to derive clinically relevant threshold values for dsSDF and global sperm DNA fragmentation (SDF) in couples undergoing intracytoplasmic sperm injection (ICSI). The main questions it aims to answer are:
- Can clinically relevant threshold values of dsSDF and global SDF predict live birth rates following ICSI?
- Does elevated dsSDF reduce live birth rates following ICSI? Participants undergoing ICSI as part of their routine fertility treatment will provide semen samples for global SDF and dsSDF assessment using the R10 Plus and R11 Plus kits, respectively, analysed using the LensHooke® X12 platform before and after sperm preparation. SDF and dsSDF assessments will be performed both prior to and following sperm washing for each participant. Embryos will be assessed from fertilization through embryo development, and following embryo transfer, participants will be prospectively followed for clinical outcomes ranging from biochemical pregnancy to live birth.
Detailed description
This prospective, two-centre observational study is designed to evaluate the impact of double-strand sperm DNA fragmentation (dsSDF) on assisted reproductive technology (ART) outcomes and to derive clinically relevant threshold values for dsSDF and global sperm DNA fragmentation (SDF) in couples undergoing intracytoplasmic sperm injection (ICSI). Although conventional sperm DNA fragmentation assays assess overall DNA damage, they do not differentiate between single- and double-strand DNA breaks. Emerging evidence suggests that dsSDF represents a more severe form of genomic damage with limited oocyte repair potential and may therefore have a greater impact on embryological and reproductive outcomes, particularly live birth.
A total of 484 infertile couples undergoing ICSI treatment at two tertiary IVF centres in India will be prospectively recruited based on predefined eligibility criteria. Semen samples will be collected on the day of ICSI following 2-3 days of sexual abstinence. Global SDF and dsSDF assessments will be performed using the LensHooke® X12 platform with the R10 Plus and R11 Plus kits, respectively. SDF testing will be conducted both before and after sperm preparation to evaluate the impact of sperm washing on DNA fragmentation parameters.
Embryos derived from enrolled participants will be prospectively assessed from fertilization through embryo development. Following embryo transfer, participants will be prospectively followed for clinical outcomes including biochemical pregnancy, clinical pregnancy, ongoing pregnancy, miscarriage, and live birth.
Receiver operating characteristic (ROC) curve analysis will be used to derive clinically relevant threshold values for dsSDF and global SDF. Multivariable regression analyses will additionally be performed to evaluate the predictive value of dsSDF and global SDF for ART outcomes while adjusting for potential confounding factors. The findings of this study are expected to improve the clinical interpretation of sperm DNA damage assessment and support the integration of dsSDF into individualized reproductive care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICSI Couples Undergoing SDF and dsSDF Assessment | – | Device: LensHooke X12 DeviceInfertile couples undergoing intracytoplasmic sperm injection (ICSI) at participating tertiary IVF centres will be prospectively enrolled based on predefined eligibility criteria. Semen samples collected on the day of ICSI will undergo assessment of global sperm DNA fragmentation (SDF) and double-strand sperm DNA fragmentation (dsSDF) using the LensHooke® X12 platform with the R10 Plus and R11 Plus kits, respectively. SDF assessments will be performed before and after sperm preparation. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will consist of infertile couples undergoing intracytoplasmic sperm injection (ICSI) at participating tertiary IVF centres in India. Inclusion and exclusion criteria have been defined to establish a relatively homogeneous study population suitable for evaluating the impact of double-strand sperm DNA fragmentation (dsSDF) and global sperm DNA fragmentation (SDF) on assisted reproductive technology (ART) outcomes while minimizing potential confounding factors related to severe male factor infertility, female reproductive pathology, and adjunctive fertility interventions.
Key inclusion criteria (6 listed)
- Males aged 21-55 years undergoing ICSI treatment for male factor infertility.
- Women with age 21-35 for self-oocyte pickup cycles
- Oocyte donor cycles with recipient age of 21-35 years of age
- Sperm with a minimum total motile sperm count of 2.0 million/mL and a minimum volume of 1.2 mL
- Patients not underwent sperm DNA fragmentation testing
Key exclusion criteria (8 listed)
- Severe male factor infertility (azoospermia or severe oligozoospermia; for this study defined as no sperm present or sample with <2 million/ml sperm count)
- Known systemic diseases (e.g., diabetes mellitus).
- Surgically retrieved sperms using testicular sperm aspiration, testicular sperm extraction and percutaneous epididymal sperm aspiration.
- Untreated endometrial or uterine factors or adnexal pathology
- Embryos underwent preimplantation genetic testing for aneuploidy testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LensHooke X12 DeviceThe LensHooke® X12 device is an automated sperm DNA fragmentation assessment platform based on the sperm chromatin dispersion (SCD) principle. In this study, the device will be used to assess global sperm DNA fragmentation (SDF) and double-strand sperm DNA fragmentation (dsSDF) using the R10 Plus and R11 Plus kits, respectively. The platform incorporates automated image acquisition and analysis to minimize operator-dependent variability and standardize sperm DNA fragmentation assessment. Semen samples collected from participants undergoing intracytoplasmic sperm injection (ICSI) will be analysed before and after sperm preparation to evaluate the association between sperm DNA damage parameters and assisted reproductive technology (ART) outcomes. | Device | ICSI Couples Undergoing SDF and dsSDF Assessment |
Primary outcome
Live Birth rate
Time frame: 24 weeks post embryo transfer
Live birth will be defined as the delivery of one or more live infants at or beyond 24 weeks of gestation following embryo transfer. Live birth rate will be calculated as the proportion of embryo transfer cycles resulting in at least one live birth.
1 secondary outcome
Clinical Threshold Values for dsSDF and Global SDF
Time frame: From fertilization assessment following intracytoplasmic sperm injection (ICSI) until live birth, approximately 18 months after participant enrolment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 36823317Alvarez JG, Garcia-Peiro A, Barros A, Ferraz L, Sousa M, Sakkas D. Double strand DNA breaks in sperm: the bad guy in the crowd. J Assist Reprod Genet. 2023 Apr;40(4):745-751. doi: 10.1007/s10815-023-02748-5. Epub 2023 Feb 24.
- Background: PubMed 32485940Agarwal A, Barbarosie C, Ambar R, Finelli R. The Impact of Single- and Double-Strand DNA Breaks in Human Spermatozoa on Assisted Reproduction. Int J Mol Sci. 2020 May 29;21(11):3882. doi: 10.3390/ijms21113882.
- Background: PubMed 37923811Wang TE, Lee CI, Huang CC, Tsao HM, Chang HC, Chang LS, Chang TA, Lee MS, Hsu CT. Innovative technology for evaluation of sperm DNA double-strand breaks diagnoses male factor infertility and prevents reproductive failures. Sci Rep. 2023 Nov 3;13(1):18996. doi: 10.1038/s41598-023-46049-4.
- Individual participant dataSharing planned: Undecided. We will share IPD on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vipin Chandra, M.B.B.S., D.G.O. principal investigator
Indira IVF Hospital Limited, India
Sandro Esteves, Ph.D. study director
Androfert Clinic, Brazil
Naval Shah, MSc study chair
Indira IVF Hospital Limited, India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sperm DNA Fragmentation and Sperm DNA Impact on ART Outcomes, run by Indira IVF Hospital Pvt Ltd at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vipin Chandra, M.B.B.S., D.G.O. (918567971239, drvipinchandra@indiraivf.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth rate (time frame: 24 weeks post embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07621991, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.