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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
intracytoplasmic sperm injection and artificial oocyte activation
Procedure/SurgeryA 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.
intracytoplasmic sperm injection
Procedure/SurgeryA single sperm will be injected within 4 hours after the follicular aspiration.
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: ICSI+AOA groupExperimental treatment 1 intervention
Group B: ICSI groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Live birth
Delivery ≥22 weeks of gestation with heartbeat and breath.
Time frame
1 year after embryo transferSecondary outcomes
1
Fertilization rate
Fertilized oocytes with two pronuclei per MII oocyte injected
Time frame
1 day after oocyte retrieval2
High-quality embryos on Day 3
Seven or eight blastomeres of equal-size and \<20% fragmentation by volume
Time frame
3 days after oocyte retrieval3
hCG positivity
Serum hCG level ≥10mIU/mL
Time frame
14 days after embryo transfer4
Number and grading of embryos/blastocysts
Number and grading of embryos/blastocysts suitable for freezing and transfer
Time frame
6 days after oocyte retrievalSponsors and contacts
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Source ClinicalTrials.gov