New treatments improve embryo implantation and live birth rates in infertile women undergoing IVF and ICSI

New research has shown the effectiveness of a first-in-class oral, non-hormonal drug in increasing the rates of embryo implantations, pregnancies and live births among infertile women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

The findings, presented at the ESHRE 40th Annual Meeting in Amsterdam, represent an important step towards the first therapeutic tool to increase embryo implantation and live birth success. The research summary was published in Human reproduction.

Globally, one in six people of childbearing age will experience infertility during their lifetime. More than 3 million IVF cycles are performed annually and yet, despite advancing IVF technologies, embryo implantation failure remains a significant challenge.

In response to this unmet need, researchers have unveiled the promising findings of their Phase II clinical trial, OXOART2. This randomized, double-blind, placebo-controlled trial, conducted in 28 centers in Europe, evaluated OXO-001, a first-in-class oral drug that acts directly on the endometrium (inner lining of the uterus) to improve embryo implantation and pregnancy rates. .

The OXOLIFE exploratory subset study analyzed 96 women aged up to 40 years who underwent a single embryo transfer, 42 women received a placebo and 54 women received a daily dose of OXO-001. Treatment began one menstrual cycle before the embryo transfer cycle and continued until five weeks after transfer.

Statistically significant improvements were observed in biochemical pregnancy rates – an early detection of pregnancy – with rates of 75.9% in the OXO-001 group compared to 52.4% in the placebo group.

Clinically relevant improvements were also seen in clinical pregnancy rates (fetal heart rate five weeks after embryo transfer) and in ongoing pregnancy rates (10 weeks after embryo transfer), being an absolute increase of +14.3 (50.0% for OXO-001 vs. 35.7). % for placebo) and an absolute increase of +10.6 (46.3% for OXO-001 vs. 35.7% for placebo).

Most importantly, there was an absolute increase of +6.9 in live birth rates (42.6% for OXO-001 versus 35.7% for placebo).

Dr. Agnès Arbat, CEO and CMO of OXOLIFE, says: “We know from scientific societies, key opinion leaders, physicians and patients that an absolute increase of more than 5 percentage points in ongoing pregnancies is considered clinically meaningful. We have observed an increase higher than +9, which gives renewed hope to patients and the scientific community. We look forward to advancing this promising treatment through the next phases of clinical development.”

The occurrence of side effects was comparable in both groups. The most common side effects were headache, nausea, vomiting, gastrointestinal problems and dizziness, most of which were mild to moderate. Most importantly, the babies showed good development during the six-month follow-up, with no differences compared to placebo. Overall, OXO-001 was well tolerated, with a high rate of compliance.

Dr. Ignasi Canals, CSO of OXOLIFE added: “We are very pleased with the results of this study, which highlight the potential of OXO-001 to become the first therapeutic treatment to increase the success of embryo implantation, with a non- hormonal drug that uses a new mechanism of action, acting directly on the endometrium.”

Professor Dr. Karen Sermon, President of ESHRE, explains: “Despite ongoing developments in ovarian stimulation, embryo manipulation and culture, improving live birth rates in medically assisted reproduction has been incremental at best. A jump of almost 7% is very good news for our patients, and hopefully this can be confirmed in larger patient groups.”