Course and outcomes of pregnancy following IVF in patients with chronic endometritis receiving complex treatment with the Superlymph medication at the preconception stage (TULIP 2 randomized controlled trial)

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Abstract

Background: Chronic endometritis (CE) is associated with unsuccessful attempts of in vitro fertilization (IVF) in 7.7–67.5% of patients.

Objective: To increase the effectiveness of IVF in patients with infertility caused by CE.

Materials and methods: The study included 600 infertile patients with CE undergoing IVF treatment. The patients were randomized into two groups (300 people each). Treatment in groups I and II included antibacterial therapy (10 days) and progesterone (6 months); patients in group I received a complex of natural antimicrobial peptides and cytokines (Superlymph) (1–4 courses after 2–3 months). During IVF cycle, one cryopreserved embryo was transferred.

Results: Pregnancy occurred in 57.0% vs. 38.7% (RR=1.47; 95% CI: 1.24–1.75, p<0.001) as a result of treatment before cryopreservation in groups I and II, live birth was noted in 45.3 and 20.7%, respectively (RR=2.19; 95% CI: 1.70–2.83, p<0.0001). The same parameters were higher in patients aged 35 and over who received Superlymph, namely by 1.6 and 2.6 times, respectively, as well as in patients suffering from infertility for 5 years or more. Therapy with Superlymph contributed to reducing the risk of miscarriage at early stages, premature birth and low weight birth by 2 times compared to the treatment without it, preeclampsia by 2 times, hypoxia and fetal growth retardation by 3 times, antenatal fetal death by 6.7 times, respectively.

Conclusion: The use of Superlymph in combination with progesterone during preconception care improves the results of IVF in patients with uterine infertility caused by CE.

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About the authors

Anton A. Sukhanov

Perinatal Medical Center; Tyumen State Medical University, Ministry of Health of Russia

Author for correspondence.
Email: such-anton@yandex.ru
ORCID iD: 0000-0001-9092-9136

PhD, Head of the Department of Family Planning and Reproduction; Associate Professor, Department of Obstetrics and Gynecology

Russian Federation, Tyumen; Tyumen

Galina B. Dikke

F.I. Inozemtsev Academy of Medical Education

Email: galadikke@yandex.ru
ORCID iD: 0000-0001-9524-8962

Dr. Med. Sci., Professor, Department of Obstetrics and Gynecology with a Course of Reproductive Medicine

Russian Federation, St. Petersburg

Vladimir V. Ostromensky

F.I. Inozemtsev Academy of Medical Education

Email: ostromenskyvv@gmail.com
ORCID iD: 0000-0001-8290-5767

PhD, Head of the Department of Obstetrics and Gynecology with a Course of Reproductive Medicine

Russian Federation, St. Petersburg

Irina I. Kukarskaya

Perinatal Medical Center; Tyumen State Medical University, Ministry of Health of Russia

Email: kukarskay@mail.ru
ORCID iD: 0000-0002-8275-3553

Dr. Med. Sci., Professor of the Department of Obstetrics, Gynecology and Reanimatology with a Course of Clinical Laboratory Diagnostics; Chief Physician; Chief Specialist in Obstetrics and Gynecology, Department of Health of the Tyumen Region

Russian Federation, Tyumen; Tyumen

Natalya V. Shilova

Gen-lab Ltd

Email: nvshilova@gmail.com
ORCID iD: 0000-0001-6734-0147

PhD, Medical director

Russian Federation, Moscow

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