ABSTRACT
Objective: Human chorionic gonadotropin (hCG) is produced by the syncytiotrophoblast and plays a key role in implantation. However, quality evidence on intrauterine administration of hCG prior to embryo transfer (ET) is lacking. Our study aimed at evaluating whether intrauterine administration of hCG before ET improves in vitro fertilization (IVF) outcomes. Design: A double-blinded randomized controlled trial (RCT) (NCT03238807) in an University-affiliated IVF center in Assiut, Egypt. The study protocol was approved by the University’s Institutional Review Board (IRB) (approval number: 17200094). Materials and Methods: We included infertile women scheduled for intra-cytoplasmic sperm injection (ICSI). After informed consent, women were randomized using a simple computer-generated random allocation in a 1:1 ratio to receive either 500 IU hCG intrauterine (hCG group), or culture media intrauterine (control group) prior to ET. Women in the hCG group received 500 IU of hCG in 0.1 mL of tissue culture media via intrauterine injection 4 minutes before ET, while women in the control group received 0.1 mL of tissue culture media. In both groups, an intra-uterine insemination (IUI) catheter was used for intrauterine administration. The patients and the clinician who conducted the procedure were blinded to the allocated intervention. Our primary outcome was live birth, while ongoing pregnancy and clinical pregnancy were secondary outcomes. According to the intention-to-treat principle, analyses of outcomes were done and were represented as risk ratios (RRs) with 95% confidence intervals (CIs). We needed a sample size of 204 to show an increase of live birth from 28% to 48% at 80% power with an alpha error of 0.05. Accounting for 8% of drop-outs, we planned to recruit 220 participants. Due to the COVID-19 pandemic, all IVF procedures have been suspended in our center since March 2020. As a consequence, recruitment was halted on 27 February 2020 at 181 participants. At the time of abstract submission, data on ongoing pregnancy are available. At the congress, we will be able to present data on live birth. Results: From July 2018 to February 2020, 181 women were randomized into the hCG group (n=90) and the control group (n=91). Baseline and cycle characteristics were comparable between the two groups. In the control group, one woman was lost to follow-up after confirmation of clinical pregnancy. Ongoing pregnancy was 23% (21/90) in the hCG group versus 19% (17/90) in the control group (RR 1.24, 95% CI 0.70 – 2.19), while clinical pregnancy was 34% (31/90) in the hCG group versus 26% (24/91) in the control group (RR 1.31, 95% CI 0.84 – 2.04). Conclusions: From the available data in this RCT, we did not find evidence that intrauterine hCG administration before ET improves ongoing pregnancy rates.