Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia

Official title

A Randomized Control Trial to Compare the Live Birth Rate Between Intracytoplasmic Sperm Injection and Artificial Oocyte Activation and Intracytoplasmic Sperm Injection Alone in Patients With Severe Teratospermia

Overview

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

• Procedure 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.
• Procedure intracytoplasmic sperm injection
  A single sperm will be injected within 4 hours after the follicular aspiration.

Primary outcome measures

• Live birth [Time frame: 1 year after embryo transfer]

Secondary outcome measures (10)

• Fertilization rate [Time frame: 1 day after oocyte retrieval]
• High-quality embryos on Day 3 [Time frame: 3 days after oocyte retrieval]
• hCG positivity [Time frame: 14 days after embryo transfer]
• Number and grading of embryos/blastocysts [Time frame: 6 days after oocyte retrieval]
• Clinical pregnancy [Time frame: 6 weeks of gestation]
• Ongoing pregnancy [Time frame: 12 weeks of gestation]
• Multiple pregnancy [Time frame: 6 weeks of gestation]
• Cumulative live birth rate (within 6 months after randomization) [Time frame: 1.5 years after the randomization]
• Miscarriage rate [Time frame: 22 weeks of pregnancy]
• Birth weights of the newborns [Time frame: 1 year after embryo transfer]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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)
• Abnormal parental karyotyping, or Medical conditions that assisted reproductive technology or pregnancy is contraindicated

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• ShangHai JIAI Genetics &I VF Institute — Shanghai

Publications

• 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. PMID 1351601
• 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. PMID 26346057
• 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. PMID 8408487
• 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. PMID 12524062
• 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. PMID 22205614
• 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. PMID 23706334
• 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. PMID 24656559
• 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. PMID 22493027

Identifiers

NCT: NCT06561451 · JIAI 2024-08

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗