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.

N/ANot Yet RecruitingNCT07626359

Indira IVF Hospital Pvt Ltd830 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

830

Conditions

Male

Interventions

Processed using density gradient centrifugation

Eligibility

Sex: ALLMin age: 21 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (9)

Recruitment

Patna, Bihar, India

Indira IVF Hospital Limited

Bangalore, Karnataka, India

Recruitment

Bhāndup, Maharashtra, India

Recruitment

Pune, Maharashtra, India

Recruitment

Delhi, National Capital Territory of Delhi, India

Recruitment

Jaipur, Rajasthan, India

LAB

Udaipur, Rajasthan, India

Recruitment

Allahābād, Uttar Pradesh, India

Recruitment

Lucknow, Uttar Pradesh, India

Outcomes

Primary Outcomes

Ongoing Pregnancy Rate

Ongoing pregnancy rate

Time frame: 12 weeks of gestation

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

Total number of good blast

Time frame: Day 5&6 after ICSI

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

Central Contacts

Shashank Sanagoudar, MS

CONTACT

91-8050406053 drsanagoudar@gmail.com

Sandro Esteves, PhD

CONTACT

s.esteves@androfert.com.br