Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-37
SponsorShangHai Ji Ai Genetics & IVF Institute
About this trial
The goal of this clinical trial is to compare the live birth rate between intracytoplasmic sperm injection (ICSI) and artificial oocyte activation (AOA) vs intracytoplasmic sperm injection alone in patients with teratospermia. The hypothesis is the live birth rate following ICSI and AOA is significantly higher than that by ICSI alone in patients with teratospermia. This is a randomized controlled trial. Participants will be randomly assigned into one of the two groups:
ICSI+AOA group: a single sperm will be injected within 4 hours after the follicular aspiration. All injected oocytes will be incubated in the calcium ionophore A23187 activation solution (C9275-1MG, Sigma, USA) for 10 min, and cultured in the cleavage medium (Cleavage Medium , Cook, United States) under standard conditions.
ICSI alone group: a single sperm will be injected within 4 hours after the follicular aspiration.
Eligibility criteria
Qualifiers
Age of women 20-37 years at the time of ovarian stimulation for ICSI
At least three matured oocytes Severe teratozoospermia: defined as abnormal sperm morphology ranging between 99-100%, including globozoospermia and tapered-head.
Disqualifiers
Presence of hydrosalpinx which is not surgically treated
Undergoing preimplantation genetic testing
Recurrent pregnancy loss (defined as two or more previous spontaneous pregnancy losses)
Known uterine abnormality (e.g., uterine congenital malformation; untreated uterine septum, adenomyosis, or submucous myoma; endometrial polyps; or intrauterine adhesions)
Trial design
Treatments tested in this trial
- intracytoplasmic sperm injection and artificial oocyte activation
- intracytoplasmic sperm injection
Treatment groups
208 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov