Male
Conditions
Keywords
pregnancy rate, Second Ejaculate, Abstinence, Microfluidic, CA0
Brief 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 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.
Interventions
PROCEDUREProcessed using density gradient centrifugation
Processed using density gradient centrifugation
PROCEDURESecond Ejaculate (collected after 1-3 hours)
The second ejaculate will be processed with two-layer density gradient centrifugation followed by standard washing.
Sponsors
Indira IVF Hospital Pvt Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
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. * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing Pregnancy Rate | 12 weeks of gestation | Ongoing pregnancy rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sperm motility and morphology after sperm sorting or second ejaculate collection. | At the day of ICSI | Sperm motility and morphology after sperm sorting or second ejaculate collection. |
| Blastocyst rate | Day 5&6 after ICSI | Blastocyst rate |
| Good Blastocyst rate | Day 5&6 after ICSI | Total number of good blast |
| Biochemical Pregnancy Rate | 2 weeks after embryo transfer | Biochemical Pregnancy Rate |
| Implantation Rate | 4-6 weeks after embryo transfer | An embryo implantation rate is the percentage of transferred embryos that successfully attach to the uterine lining and develop into a clinical pregnancy |
| Clinical Pregnancy Rate | 4-6 weeks after embryo transfer | 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 |
| First trimester Miscarriage Rate | Till 12 weeks after embryo transfer | Miscarriages are very common, occurring in about 10% to 20% of all known pregnancies. |
Countries
India
Contacts
CONTACTShashank Sanagoudar, MS
CONTACTSandro Esteves, PhD
PRINCIPAL_INVESTIGATORVipin Chandra, DGO
Indira IVF Hospital Limited
Outcome results
None listed