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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICSI+AOA group | Experimental | 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 group | Active Comparator | a single sperm will be injected within 4 hours after the follicular aspiration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intracytoplasmic sperm injection and artificial oocyte activation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth | Delivery ≥22 weeks of gestation with heartbeat and breath. | 1 year after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization rate | Fertilized oocytes with two pronuclei per MII oocyte injected | 1 day after oocyte retrieval |
| High-quality embryos on Day 3 | Seven or eight blastomeres of equal-size and <20% fragmentation by volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HE LI, MD | Contact | +8613817223099 | lihe198900@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoxi Sun, PhD | Shanghai JiAi Genetics & IVF Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ShangHai JIAI Genetics &I VF Institute | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1351601 | Background | 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. | |
| 26346057 | Background | 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. |
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Data from the trial will be shared according to the International Committee of Medical Journal Editors guidelines. Individual participant data that underlie the results after deidentification (text, tables, figures and appendices) and the study protocol will be shared. On request, data can be shared with parties presenting relevant aims for the use of data. Data will be available from 3 months to 5 years following article publication.
Data will be available from 3 months to 5 years following article publication
On request, data can be shared with parties presenting relevant aims for the use of data. Please contact the researcher through email: lihe198900@163.com.
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D000072660 | Teratozoospermia |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D020554 | Sperm Injections, Intracytoplasmic |
| ID | Term |
|---|---|
| D005307 | Fertilization in Vitro |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
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|
| intracytoplasmic sperm injection | Procedure | A single sperm will be injected within 4 hours after the follicular aspiration. |
|
| 3 days after oocyte retrieval |
| hCG positivity | Serum hCG level ≥10mIU/mL | 14 days after embryo transfer |
| Number and grading of embryos/blastocysts | Number and grading of embryos/blastocysts suitable for freezing and transfer | 6 days after oocyte retrieval |
| Clinical pregnancy | the presence of an intrauterine gestational sac on transvaginal ultrasound at 6 gestational weeks. | 6 weeks of gestation |
| Ongoing pregnancy | a viable pregnancy beyond 12 weeks of gestation | 12 weeks of gestation |
| Multiple pregnancy | presence of more than one intrauterine sac at 6 weeks of gestation | 6 weeks of gestation |
| Cumulative live birth rate (within 6 months after randomization) | Any live birth arising from embryo transfer within 6 months after randomization | 1.5 years after the randomization |
| Miscarriage rate | A clinically recognized pregnancy loss before 22 weeks of pregnancy. The denominator is the clinical pregnancy. | 22 weeks of pregnancy |
| Birth weights of the newborns | Birth weights of the newborns | 1 year after embryo transfer |
| 8408487 | Background | 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. |
| 12524062 | Background | 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. |
| 22205614 | Background | 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. |
| 23706334 | Background | 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. |
| 24656559 | Background | 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. |
| 22493027 | Background | 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. |
| D052801 |
| Male Urogenital Diseases |
| D008919 | Investigative Techniques |