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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Ejaculate | Experimental | Processed using a centrifugation-free sperm sorting device |
|
| Second Ejaculate | Experimental | The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Processed using density gradient centrifugation | Procedure | Processed using density gradient centrifugation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing Pregnancy Rate | Ongoing pregnancy rate | 12 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm motility and morphology after sperm sorting or second ejaculate collection. | Sperm motility and morphology after sperm sorting or second ejaculate collection. | At the day of ICSI |
| Blastocyst rate |
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Inclusion Criteria:
• 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shashank Sanagoudar, MS | Contact | 91-8050406053 | drsanagoudar@gmail.com | |
| Sandro Esteves, PhD | Contact | s.esteves@androfert.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Vipin Chandra, DGO | Indira IVF Hospital Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruitment | Patna | Bihar | 800014 | India | ||
| Indira IVF Hospital Limited |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34472769 | Result | 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. | |
| Result | https://www.sciencedirect.com/science/article/pii/S0015028215018749 |
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Data will be shared on request
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| Second Ejaculate (collected after 1-3 hours) | Procedure | The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing. |
|
Blastocyst rate
| Day 5&6 after ICSI |
| Good Blastocyst rate | Total number of good blast | Day 5&6 after ICSI |
| Biochemical Pregnancy Rate | Biochemical Pregnancy Rate | 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 | 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 | 4-6 weeks after embryo transfer |
| First trimester Miscarriage Rate | Miscarriages are very common, occurring in about 10% to 20% of all known pregnancies. | Till 12 weeks after embryo transfer |
| Bangalore |
| Karnataka |
| 560078 |
| India |
|
| Recruitment | Bhāndup | Maharashtra | India |
| Recruitment | Pune | Maharashtra | India |
| Recruitment | Delhi | National Capital Territory of Delhi | India |
| Recruitment | Jaipur | Rajasthan | India |
| LAB | Udaipur | Rajasthan | 313001 | India |
|
| Recruitment | Allahābād | Uttar Pradesh | India |
| Recruitment | Lucknow | Uttar Pradesh | India |