Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia
NCT ID: NCT06561451
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
208 participants
INTERVENTIONAL
2024-08-30
2027-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ICSI+AOA group
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.
intracytoplasmic 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.
ICSI group
a single sperm will be injected within 4 hours after the follicular aspiration.
intracytoplasmic sperm injection
A single sperm will be injected within 4 hours after the follicular aspiration.
Interventions
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intracytoplasmic 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.
intracytoplasmic sperm injection
A single sperm will be injected within 4 hours after the follicular aspiration.
Eligibility Criteria
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Inclusion Criteria
2. At least three matured oocytes Severe teratozoospermia: defined as abnormal sperm morphology ranging between 99-100%, including globozoospermia and tapered-head.
Exclusion Criteria
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
20 Years
37 Years
ALL
No
Sponsors
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ShangHai Ji Ai Genetics & IVF Institute
OTHER
Responsible Party
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Principal Investigators
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Xiaoxi Sun, PhD
Role: STUDY_DIRECTOR
Shanghai JiAi Genetics & IVF Institute
Locations
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ShangHai JIAI Genetics &I VF Institute
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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LI HE, MD
Role: primary
References
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Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.
Yeste M, Jones C, Amdani SN, Patel S, Coward K. Oocyte activation deficiency: a role for an oocyte contribution? Hum Reprod Update. 2016 Jan-Feb;22(1):23-47. doi: 10.1093/humupd/dmv040. Epub 2015 Sep 7.
Van Steirteghem AC, Nagy Z, Joris H, Liu J, Staessen C, Smitz J, Wisanto A, Devroey P. High fertilization and implantation rates after intracytoplasmic sperm injection. Hum Reprod. 1993 Jul;8(7):1061-6. doi: 10.1093/oxfordjournals.humrep.a138192.
De Vos A, Van De Velde H, Joris H, Verheyen G, Devroey P, Van Steirteghem A. Influence of individual sperm morphology on fertilization, embryo morphology, and pregnancy outcome of intracytoplasmic sperm injection. Fertil Steril. 2003 Jan;79(1):42-8. doi: 10.1016/s0015-0282(02)04571-5.
Lu YH, Gao HJ, Li BJ, Zheng YM, Ye YH, Qian YL, Xu CM, Huang HF, Jin F. Different sperm sources and parameters can influence intracytoplasmic sperm injection outcomes before embryo implantation. J Zhejiang Univ Sci B. 2012 Jan;13(1):1-10. doi: 10.1631/jzus.B1100216.
Greco E, Scarselli F, Fabozzi G, Colasante A, Zavaglia D, Alviggi E, Litwicka K, Varricchio MT, Minasi MG, Tesarik J. Sperm vacuoles negatively affect outcomes in intracytoplasmic morphologically selected sperm injection in terms of pregnancy, implantation, and live-birth rates. Fertil Steril. 2013 Aug;100(2):379-85. doi: 10.1016/j.fertnstert.2013.04.033. Epub 2013 May 23.
Vanden Meerschaut F, Nikiforaki D, Heindryckx B, De Sutter P. Assisted oocyte activation following ICSI fertilization failure. Reprod Biomed Online. 2014 May;28(5):560-71. doi: 10.1016/j.rbmo.2014.01.008. Epub 2014 Jan 31.
Vanden Meerschaut F, Nikiforaki D, De Gheselle S, Dullaerts V, Van den Abbeel E, Gerris J, Heindryckx B, De Sutter P. Assisted oocyte activation is not beneficial for all patients with a suspected oocyte-related activation deficiency. Hum Reprod. 2012 Jul;27(7):1977-84. doi: 10.1093/humrep/des097. Epub 2012 Apr 4.
Other Identifiers
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JIAI 2024-08
Identifier Type: -
Identifier Source: org_study_id
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