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A Prospective, Randomized, Sibling-Oocyte Controlled Clinical Study on the Efficacy and Safety of SLS-IMSI in Patients with Severe Oligozoospermia

A Prospective, Randomized, Sibling-Oocyte Controlled Clinical Study on the Efficacy and Safety of SLS-IMSI in Patients with Severe Oligozoospermia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125764
Enrollment
Unknown
Registered
2026-05-31
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male infertility

Interventions

SLS-IMSI Group:Perform Intracytoplasmic morphologically-selected sperm injection with ultra-high magnification after single-layer strip sperm spread processing of the semen
ICSI Group:Perform conventional intracytoplasmic sperm injection with sperm selected under 200-400x magnification

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Male partners aged 22-45 years, diagnosed with severe oligozoospermia (total sperm count: 0.1-5.0 × 10^6 per entire sample); 2. Female partners aged =5, AMH >=1.2 ng/mL); 3. Number of mature (MII) oocytes obtained in the current cycle >=6; 4. The study participant and his/her spouse have provided signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of other well-defined oocyte-related factors contributing to infertility (e.g., oocyte maturation disorder); 2. Presence of definite uterine anomalies (e.g., septate uterus, unicornuate uterus); 3. Presence of contraindications to pregnancy or assisted reproductive technology; 4. Presence of symptoms of urinary tract infection.

Design outcomes

Primary

MeasureTime frame
blastocyst formation rate;

Secondary

MeasureTime frame
2PN fertilization rate;Day 3 good-quality embryo rate;D5 good-quality blastocyst formation rate;good-quality blastocyst formation rate;available blastocyst rate;biochemical pregnancy rate;clinical pregnancy rate;implantation rate;miscarriage rate;live birth rate;cumulative live birth rate;

Countries

China

Contacts

Public ContactHe Xiaojin

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

hxj0117@126.com+86 155 5551 7878

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026