Clinical trial NCT06561451: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Male Infertility
Teratospermia
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 208
Sex: ALL
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Live birth
timeFrame: 1 year after embryo transfer
Secondary outcomes:
measure: Fertilization rate
timeFrame: 1 day after oocyte retrieval
measure: High-quality embryos on Day 3
timeFrame: 3 days after oocyte retrieval
measure: hCG positivity
timeFrame: 14 days after embryo transfer
measure: Number and grading of embryos/blastocysts
timeFrame: 6 days after oocyte retrieval
measure: Clinical pregnancy
timeFrame: 6 weeks of gestation
measure: Ongoing pregnancy
timeFrame: 12 weeks of gestation
measure: Multiple pregnancy
timeFrame: 6 weeks of gestation
measure: Cumulative live birth rate (within 6 months after randomization)
timeFrame: 1.5 years after the randomization
measure: Miscarriage rate
timeFrame: 22 weeks of pregnancy
measure: Birth weights of the newborns
timeFrame: 1 year after embryo transfer
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ShangHai JIAI Genetics &I VF Institute
Study officials:
affiliation: Shanghai JiAi Genetics & IVF Institute
name: Xiaoxi Sun, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.