An interventional study of Processed using density gradient centrifugation and Second Ejaculate (collected after 1-3 hours) in Male, sponsored by Indira IVF Hospital Pvt Ltd. Not yet recruiting at 9 sites in India. Open to participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Indira IVF Hospital Pvt Ltd · Not applicable, Interventional, and Treatment
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.
Indira IVF Hospital Pvt Ltd is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Processed using a centrifugation-free sperm sorting device
Procedure: Processed using density gradient centrifugation
The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.
Procedure: Second Ejaculate (collected after 1-3 hours)
Processed using density gradient centrifugation
The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.
Ongoing Pregnancy Rate
Ongoing pregnancy rate
Time frame: 12 weeks of gestation
Sperm motility and morphology after sperm sorting or second ejaculate collection.
Sperm motility and morphology after sperm sorting or second ejaculate collection.
Time frame: At the day of ICSI
Blastocyst rate
Blastocyst rate
Time frame: Day 5&6 after ICSI
Good Blastocyst rate
Total number of good blast
Time frame: Day 5&6 after ICSI
Biochemical Pregnancy Rate
Biochemical Pregnancy Rate
Time frame: 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
Time frame: 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
Time frame: 4-6 weeks after embryo transfer
First trimester Miscarriage Rate
Miscarriages are very common, occurring in about 10% to 20% of all known pregnancies.
Time frame: Till 12 weeks after embryo transfer
Plan to share: No — Data will be shared on request
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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