ClinConnect ClinConnect Logo
Search / Trial NCT06561451

Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia

Launched by SHANGHAI JI AI GENETICS & IVF INSTITUTE · Aug 17, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of helping couples with male infertility due to severe teratospermia, a condition where most sperm have an abnormal shape. The researchers want to find out if using a technique called artificial oocyte activation (AOA) along with a procedure called intracytoplasmic sperm injection (ICSI) leads to more live births compared to using ICSI alone. In this trial, eligible women aged 20 to 37 who have at least three mature eggs and whose partners have severe teratospermia may participate.

Participants will be randomly divided into two groups: one group will receive the combination of ICSI and AOA, while the other group will only receive ICSI. After the sperm is injected into the eggs, those in the AOA group will have their eggs treated with a special solution to potentially increase the chances of pregnancy. It's important to note that certain conditions, such as untreated uterine issues or previous pregnancy losses, may exclude someone from joining the trial. This study aims to provide valuable insights into improving fertility treatments for those affected by severe teratospermia.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age of women 20-37 years at the time of ovarian stimulation for ICSI
  • 2. At least three matured oocytes Severe teratozoospermia: defined as abnormal sperm morphology ranging between 99-100%, including globozoospermia and tapered-head.
  • Exclusion Criteria:
  • 1. Presence of hydrosalpinx which is not surgically treated
  • 2. Undergoing preimplantation genetic testing
  • 3. Recurrent pregnancy loss (defined as two or more previous spontaneous pregnancy losses)
  • 4. Known uterine abnormality (e.g., uterine congenital malformation; untreated uterine septum, adenomyosis, or submucous myoma; endometrial polyps; or intrauterine adhesions)
  • 5. Abnormal parental karyotyping, or Medical conditions that assisted reproductive technology or pregnancy is contraindicated

About Shanghai Ji Ai Genetics & Ivf Institute

Shanghai Ji Ai Genetics & IVF Institute is a leading healthcare institution specializing in reproductive medicine and genetic research. With a commitment to advancing assisted reproductive technologies and genetic diagnostics, the institute offers a comprehensive range of services, including in vitro fertilization (IVF), genetic screening, and fertility preservation. Renowned for its innovative approaches and state-of-the-art facilities, Ji Ai Genetics & IVF Institute is dedicated to improving patient outcomes through cutting-edge clinical trials and research initiatives, positioning itself at the forefront of reproductive healthcare in China and beyond.

Locations

Shanghai, , China

Patients applied

0 patients applied

Trial Officials

Xiaoxi Sun, PhD

Study Director

Shanghai JiAi Genetics & IVF Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported