Male Infertility, Teratospermia
Conditions
Brief summary
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.
Interventions
PROCEDUREintracytoplasmic sperm injection and artificial oocyte activation
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.
PROCEDUREintracytoplasmic sperm injection
A single sperm will be injected within 4 hours after the follicular aspiration.
Sponsors
ShangHai Ji Ai Genetics & IVF Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 37 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth | 1 year after embryo transfer | Delivery ≥22 weeks of gestation with heartbeat and breath. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy | 12 weeks of gestation | a viable pregnancy beyond 12 weeks of gestation |
| Multiple pregnancy | 6 weeks of gestation | presence of more than one intrauterine sac at 6 weeks of gestation |
| Fertilization rate | 1 day after oocyte retrieval | Fertilized oocytes with two pronuclei per MII oocyte injected |
| High-quality embryos on Day 3 | 3 days after oocyte retrieval | Seven or eight blastomeres of equal-size and \<20% fragmentation by volume |
| hCG positivity | 14 days after embryo transfer | Serum hCG level ≥10mIU/mL |
| Number and grading of embryos/blastocysts | 6 days after oocyte retrieval | Number and grading of embryos/blastocysts suitable for freezing and transfer |
| Cumulative live birth rate (within 6 months after randomization) | 1.5 years after the randomization | Any live birth arising from embryo transfer within 6 months after randomization |
| Miscarriage rate | 22 weeks of pregnancy | A clinically recognized pregnancy loss before 22 weeks of pregnancy. The denominator is the clinical pregnancy. |
| Clinical pregnancy | 6 weeks of gestation | the presence of an intrauterine gestational sac on transvaginal ultrasound at 6 gestational weeks. |
| Birth weights of the newborns | 1 year after embryo transfer | Birth weights of the newborns |
Countries
China
Contacts
CONTACTHE LI, MD
STUDY_DIRECTORXiaoxi Sun, PhD
Shanghai JiAi Genetics & IVF Institute
Outcome results
None listed