MaleSENCT07626359
Randomized Non-inferiority Within-Patient Trial of Density Gradient Processing of Sequential Ejaculates Versus Centrifugation-free Sperm Separation Device for ICSI in Men With Elevated Sperm DNA Fragmentation.
A study testing Processed using density gradient centrifugation and Second Ejaculate (collected after 1-3 hours) in people with Male, run by Indira IVF Hospital Pvt Ltd at 9 sites in India.
Trial summary
Elevated SDF can adversely impact fertilization, embryo development, and pregnancy outcomes in IVF-ICSI cycles. Two pragmatic strategies aim to reduce SDF on the day of ICSI: (i) obtaining a second ejaculate shortly after the first to reduce oxidative damage and transit time; and (ii) selecting sperm via… Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Male
- What is being tested?
- Processed using density gradient centrifugation and Second Ejaculate (collected after 1-3 hours)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 9 sitesIndia
- Study dates
- 5 Oct 2026to 25 Mar 2028
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Elevated SDF defined as DFI >20 %measured by the sperm chromatin dispersion (SCD) test performed in a participating center's andrology laboratory, using a harmonized protocol under standardized conditions after 2-3 days of ejaculatory abstinence, and within 90 days (≤3 months) prior to enrollment.
- Male partners 21-45 years;
- Female partners 21-35 years.
- Undergoing IVF/ICSI.
- No known genetic or chromosomal abnormalities.
- Minimum 4 MII oocyte patients shall be included
Who cannot join
- Azoospermia or severe oligoasthenozoospermia (<1 million motile sperm/mL).
- Significant systemic disease (e.g., uncontrolled diabetes, malignancy).
- History of a prior ICSI cycle with no embryo development.
- Relevant female factors: untreated adnexal pathology ,a history of a thin endometrium (<7 mm) following endometrium preparation for embryo transfer
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sandro Esteves, PhD contact
9 sites in 1 country
India9 sites
Recruitment
Allahābād, Uttar Pradesh
Indira IVF Hospital Limited
Bangalore, Karnataka, 560078
Shyam Gupta, MD, centerhead.bangalore@indiraivf.in
Shyam Gupta, MD
Recruitment
Bhāndup, Maharashtra
Recruitment
Delhi, National Capital Territory of Delhi
Recruitment
Jaipur, Rajasthan
Recruitment
Lucknow, Uttar Pradesh
Recruitment
Patna, Bihar, 800014
Recruitment
Pune, Maharashtra
LAB
Udaipur, Rajasthan, 313001
Shashank Sannagoudar, MS, 8050406053, drsanagoudar@gmail.com
Vipin Chandra, DGO, drvipinchandra@indiraivf.in
About this study
Elevated SDF can adversely impact fertilization, embryo development, and pregnancy outcomes in IVF-ICSI cycles. Two pragmatic strategies aim to reduce SDF on the day of ICSI: (i) obtaining a second ejaculate shortly after the first to reduce oxidative damage and transit time; and (ii) selecting sperm via centrifugation-free sperm separation device, which enriches for motile sperm with intact DNA. There are limited direct comparisons between these strategies; this study addresses that gap.
- Conditions
- Male
- Being tested
- Processed using density gradient centrifugation, Second Ejaculate (collected after 1-3 hours)
- Keywords
- pregnancy rate, Second Ejaculate, Abstinence, Microfluidic, CA0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Processed using density gradient centrifugationProcedure or surgery
Processed using density gradient centrifugation
Second Ejaculate (collected after 1-3 hours)Procedure or surgery
The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.
| Study group | Role | What they receive |
|---|---|---|
| First Ejaculate | Experimental | Processed using a centrifugation-free sperm sorting device Receives: Procedure: Processed using density gradient centrifugation |
| Second Ejaculate | Experimental | The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing. Receives: Procedure: Second Ejaculate (collected after 1-3 hours) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Pregnancy Rate
Ongoing pregnancy rate
Measured: 12 weeks of gestation
Secondary outcomes (7)
Sperm motility and morphology after sperm sorting or second ejaculate collection.
Sperm motility and morphology after sperm sorting or second ejaculate collection.
Measured: At the day of ICSI
Blastocyst rate
Blastocyst rate
Measured: Day 5&6 after ICSI
Good Blastocyst rate
Total number of good blast
Measured: Day 5&6 after ICSI
Biochemical Pregnancy Rate
Biochemical Pregnancy Rate
Measured: 2 weeks after embryo transfer
Implantation Rate
An embryo implantation rate is the percentage of transferred embryos that successfully attach to the uterine lining and develop into a clinical pregnancy
Measured: 4-6 weeks after embryo transfer
Clinical Pregnancy Rate
measures the percentage of fertility treatment cycles (like IVF) that result in a pregnancy confirmed by an ultrasound showing a gestational sac or fetal heartbeat
Measured: 4-6 weeks after embryo transfer
First trimester Miscarriage Rate
Miscarriages are very common, occurring in about 10% to 20% of all known pregnancies.
Measured: Till 12 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start5 Oct 2026 (estimated)
- Primary completion25 Dec 2027 (estimated)
- Study completion25 Mar 2028 (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 MaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indira IVF Hospital Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Vipin Chandra, Indira IVF Hospital Pvt Ltd
- Investigators
- Vipin Chandra, DGO, Principal investigator, Indira IVF Hospital Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626359
- Sponsor's protocol ID
- IIHL-UDR/P/007_2025
- Acronym
- SE
- Status last verified
- Sep 2026
- First submitted
- 30 May 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared on request
Publications
Humaidan P, Haahr T, Povlsen BB, Kofod L, Laursen RJ, Alsbjerg B, Elbaek HO, Esteves SC. The combined effect of lifestyle intervention and antioxidant therapy on sperm DNA fragmentation and seminal oxidative stress in IVF patients: a pilot study. Int Braz J Urol. 2022 Jan-Feb;48(1):131-156. doi: 10.1590/S1677-5538.IBJU.2021.0604.
PubMed 34472769https://www.sciencedirect.com/science/article/pii/S0015028215018749
Chandra V, Sanagoudar S, Shinde J, Shah N, Suwalka I, Esteves SC. Randomized non-inferiority within-patient trial of density gradient processing of sequential ejaculates versus centrifugation-free sperm separation device for ICSI in men with elevated sperm DNA fragmentation- study protocol. Front Urol. 2026 Sep 28;6:1913330. doi: 10.3389/fruro.2026.1913330. eCollection 2026.
PubMed 42866290
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Non-inferiority Within-Patient Trial of Density Gradient Processing of Sequential Ejaculates Versus Centrifugation-free Sperm Separation Device for ICSI in Men With Elevated Sperm DNA Fragmentation.
- ClinicalTrials.gov ID
- NCT07626359
- Acronym / sponsor ID
- SE / IIHL-UDR/P/007_2025
- Conditions
- Male
- Keywords
- pregnancy rate, Second Ejaculate, Abstinence, Microfluidic, CA0
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 830 participants (estimated)
- Lead sponsor
- Indira IVF Hospital Pvt LtdUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 25 Dec 2027 (estimated)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 4 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.
Elevated SDF can adversely impact fertilization, embryo development, and pregnancy outcomes in IVF-ICSI cycles. Two pragmatic strategies aim to reduce SDF on the day of ICSI: (i) obtaining a second ejaculate shortly after the first to reduce oxidative damage and transit time; and (ii) selecting sperm via centrifugation-free sperm separation device, which enriches for motile sperm with intact DNA. There are limited direct comparisons between these strategies; this study addresses that gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Ejaculate | Experimental | Procedure: Processed using density gradient centrifugationProcessed using a centrifugation-free sperm sorting device |
| Second Ejaculate | Experimental | Procedure: Second Ejaculate (collected after 1-3 hours)The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Elevated SDF defined as DFI >20 %measured by the sperm chromatin dispersion (SCD) test performed in a participating center's andrology laboratory, using a harmonized protocol under standardized conditions after 2-3 days of ejaculatory abstinence, and within 90 days (≤3 months) prior to enrollment.
Key exclusion criteria (4 listed)
- Azoospermia or severe oligoasthenozoospermia (<1 million motile sperm/mL).
- Significant systemic disease (e.g., uncontrolled diabetes, malignancy).
- History of a prior ICSI cycle with no embryo development.
- Relevant female factors: untreated adnexal pathology ,a history of a thin endometrium (<7 mm) following endometrium preparation for embryo transfer
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 |
|---|---|---|
| Processed using density gradient centrifugationProcessed using density gradient centrifugation | Procedure or surgery | First Ejaculate |
| Second Ejaculate (collected after 1-3 hours)The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing. | Procedure or surgery | Second Ejaculate |
Primary outcome
Ongoing Pregnancy Rate
Time frame: 12 weeks of gestation
Ongoing pregnancy rate
7 secondary outcomes
Sperm motility and morphology after sperm sorting or second ejaculate collection.
Time frame: At the day of ICSI
Blastocyst rate
Time frame: Day 5&6 after ICSI
Good Blastocyst rate
Time frame: Day 5&6 after ICSI
Biochemical Pregnancy Rate
Time frame: 2 weeks after embryo transfer
Implantation Rate
Time frame: 4-6 weeks after embryo transfer
Clinical Pregnancy Rate
Time frame: 4-6 weeks after embryo transfer
First trimester Miscarriage Rate
Time frame: Till 12 weeks after embryo transfer
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 23 Sep 2026.
- Results publication: PubMed 34472769Humaidan P, Haahr T, Povlsen BB, Kofod L, Laursen RJ, Alsbjerg B, Elbaek HO, Esteves SC. The combined effect of lifestyle intervention and antioxidant therapy on sperm DNA fragmentation and seminal oxidative stress in IVF patients: a pilot study. Int Braz J Urol. 2022 Jan-Feb;48(1):131-156. doi: 10.1590/S1677-5538.IBJU.2021.0604.
- Results publicationhttps://www.sciencedirect.com/science/article/pii/S0015028215018749
- Derived from this study: PubMed 42866290Chandra V, Sanagoudar S, Shinde J, Shah N, Suwalka I, Esteves SC. Randomized non-inferiority within-patient trial of density gradient processing of sequential ejaculates versus centrifugation-free sperm separation device for ICSI in men with elevated sperm DNA fragmentation- study protocol. Front Urol. 2026 Sep 28;6:1913330. doi: 10.3389/fruro.2026.1913330. eCollection 2026.
- Individual participant dataSharing planned: No. Data will be shared 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.
Sandro Esteves, PhD contact
Vipin Chandra, DGO principal investigator
Indira IVF Hospital Limited
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Processed using density gradient centrifugation and Second Ejaculate (collected after 1-3 hours) in people with Male, run by Indira IVF Hospital Pvt Ltd at 9 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 4 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Shashank Sanagoudar, MS (91-8050406053, drsanagoudar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing Pregnancy Rate (time frame: 12 weeks of gestation). 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 NCT07626359, 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 23 Sep 2026.