Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte.
G Palermo, H Joris, P Devroey...
https://pubmed.ncbi.nlm.nih.gov/1351601Actively Recruiting
Phase Not Applicable
Age: 20Years - 37Years
All Genders
ID06561451
A Randomized Control Trial Comparing Live Birth Rates Between Intracytoplasmic Sperm Injection with Artificial Oocyte Activation and Intracytoplasmic Sperm Injection Alone in Patients With Severe Teratospermia
Led by ShangHai Ji Ai Genetics & IVF Institute · Updated on 2026-02-02
208
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial studies patients with severe teratospermia, a condition causing abnormal sperm shape, to compare the live birth rates between two fertility treatments: intracytoplasmic sperm injection (ICSI) combined with artificial oocyte activation (AOA) versus ICSI alone. The main goal is to see if adding AOA improves the chances of live birth in these patients through a randomized controlled trial. Participants are randomly assigned to one of two groups. In the ICSI+AOA group, a single sperm is injected into each egg within 4 hours after egg retrieval, then the eggs are incubated in a calcium ionophore activation solution for 10 minutes before being cultured. In the ICSI alone group, a single sperm is injected within 4 hours after egg retrieval, without the additional activation step. During the study, participants undergo ovarian stimulation to retrieve mature eggs, followed by the assigned fertilization procedure. Researchers will monitor outcomes including live birth rates one year after embryo transfer, fertilization rates, embryo quality, pregnancy markers, miscarriage rates, and birth weights. The trial includes ongoing monitoring of pregnancy status and cumulative live birth rates up to 1.5 years after randomization.
CONDITIONS
Brief Title
Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia
Who Can Participate
Age: 20Years - 37Years
All Genders
Eligibility Criteria
You may qualify if you...
- Women aged 20 to 37 years at the time of ovarian stimulation for ICSI
- At least three mature eggs available for fertilization
- Severe teratospermia with abnormal sperm shape between 99-100%, including globozoospermia and tapered-head sperm
You will not qualify if you...
- Untreated hydrosalpinx
- Undergoing preimplantation genetic testing
- Recurrent pregnancy loss defined as two or more previous miscarriages
- Known uterine abnormalities such as congenital malformations, untreated uterine septum, adenomyosis, submucous myoma, endometrial polyps, or intrauterine adhesions
- Abnormal parental karyotyping or medical conditions that contraindicate assisted reproductive technology or pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single procedure with follow-up until pregnancy confirmation
Participants undergo intracytoplasmic sperm injection (ICSI) with or without artificial oocyte activation. The procedure involves sperm injection shortly after follicular aspiration, followed by embryo culture under standard conditions.
1 procedure visit and several follow-up visits up to 12 weeks gestation
Follow-up
Duration - Up to 1 year after embryo transfer
Participants are monitored for pregnancy outcomes, including clinical pregnancy, ongoing pregnancy, and live birth over the course of up to 1 year after embryo transfer.
Periodic visits for pregnancy assessments up to 1 year
Trial Site Locations
Total: 1 location
1
ShangHai JIAI Genetics &I VF Institute
Shanghai, China
Actively Recruiting
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Research Team
H
HE LI, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Oocyte activation deficiency: a role for an oocyte contribution?
Marc Yeste, Celine Jones, Siti Nornadhirah Amdani...
https://pubmed.ncbi.nlm.nih.gov/26346057High fertilization and implantation rates after intracytoplasmic sperm injection.
A C Van Steirteghem, Z Nagy, H Joris...
https://pubmed.ncbi.nlm.nih.gov/8408487Influence of individual sperm morphology on fertilization, embryo morphology, and pregnancy outcome of intracytoplasmic sperm injection.
Anick De Vos, Hilde Van De Velde, Hubert Joris...
https://pubmed.ncbi.nlm.nih.gov/12524062Different sperm sources and parameters can influence intracytoplasmic sperm injection outcomes before embryo implantation.
Yue-hong Lu, Hui-juan Gao, Bai-jia Li...
https://pubmed.ncbi.nlm.nih.gov/22205614Sperm vacuoles negatively affect outcomes in intracytoplasmic morphologically selected sperm injection in terms of pregnancy, implantation, and live-birth rates.
Ermanno Greco, Filomena Scarselli, Gemma Fabozzi...
https://pubmed.ncbi.nlm.nih.gov/23706334Assisted oocyte activation following ICSI fertilization failure.
Frauke Vanden Meerschaut, Dimitra Nikiforaki, Björn Heindryckx...
https://pubmed.ncbi.nlm.nih.gov/24656559Assisted oocyte activation is not beneficial for all patients with a suspected oocyte-related activation deficiency.
F Vanden Meerschaut, D Nikiforaki, S De Gheselle...
https://pubmed.ncbi.nlm.nih.gov/22493027