Pregnancy and neonatal outcomes of infertile patients undergoing frozen-thawed embryo transfer after artificial oocyte activation: a six-year population-based retrospective study

Abstract

To evaluate the clinical outcomes and safety of artificial oocyte activation (AOA) in patients with frozen-thawed embryo transfer (FET). This was a retrospective single-center cohort study from January 2011 to December 2016. A total of 6806 patients of FET were divided into two cohorts: (1) routine ICSI group includes 6605 patients transferred embryos from ICSI. (2) ICSI-AOA group includes 201 patients transferred embryos from ICSI combined with AOA. Data were collected from the first FET cycle of each patient. All participants provided informed consent after receiving counseling concerning infertility treatments. Based on the published literatures, patient treated with AOA according to the following criteria: (1) ICSI fertilization rate ≤50 (in-house and out-house cases); (2) good quality embryo rate ≤30% (in-house and out-house cases); (3) severe oligoasthenoteratozoospermia or teratozoospermia; and (4) testicular sperm aspiration (TESA) or percutaneous epididymal sperm aspiration (PESA). AOA was performed by exposure to 10 μM of ionomycin for 10 minutes after 1 hour of ICSI. The procedures of ovarian stimulation, ICSI, embryo assessment, freezing, and thawing, endometrial preparation, and FET have been described in previous studies The Pregnancy and neonatal outcomes were assessed according to the terms defined based on the International Committee for Monitoring Assisted Reproductive Technology and the World Health Organization revised glossary of ART terminology. Compare differences of rates were performed by the Chi-square test or Fisher's exact test as appropriate. Compare differences in mean values were performed by Student’s t-test. P < 0.05 was considered statistically significant. The pregnancy outcome in two cohorts of 6605 patients with routine ICSI and 201 patients with ICSI-AOA showed no statistically significant difference in the rates of clinical pregnancy, implantation, abortion, ectopic pregnancy, multiples pregnancy and live birth. Moreover, when compared to the neonatal outcomes, no statistically significant differences were found in the birth defect rate, birth weight, low birth weight rate, birth length, gestational age, and fetal sex ratio among 3213 babies and 93 babies born from routine ICSI group and ICSI-AOA group, respectively. The application of AOA in specific infertile patients could yield comparable FET pregnancy and neonatal outcomes to patients with routine ICSI. Moreover, AOA with ionomycin does not increase the risk of birth defects for the offspring born from FET. This is the first clinical outcome and safety assessment of AOA on FET patients in a large retrospective cohort.Tabled 1Table 1The pregnancy outcomes of FET cycles between routine ICSI and ICSI-AOA patientsOutcomesRoutine ICSIICSI-AOAP valueClinical pregnancy rate(%)47.72(3152/6605)47.26(95/201)0.898Implantation rate(%)32.48(4010/12346)32.60(118/362)0.963Miscarriage(%) rate14.94(471/3152)16.84(16/95)0.609Ectopic pregnancy rate (%)1.43(45/3152)2.11(2/95)0.913Live birth rate (%)39.20(2589/6605)37.31(75/201)0.59Multiples birth rate(%)24.10(624/2589)24.00(18/75)0.984No. of children321393Birth Weight (g)3018.4±624.73019.6±605.60.986Body Gestational age (weeks)37.99±2.0137.92±2.410.78Gender (male/female)1614/159943/500.447Live birth defect rate(%)1.21%(39/3213)1.08%(1/93)0.904 Open table in a new tab