NCT05720169

Fetal, Obstetrics and Reproduction Genomics

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Fundación Ginemed · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the impact of a clinical screening strategy and genomic analysis of the factors involved in Placental Dysfunction (Preeclampsia and IUGR) in women of advanced maternal age undergoing assisted reproduction techniques (ART), specifically, in vitro fertilization (IVF) and oocyte donation.

Detailed description

Given society's shift towards later childbearing, partly related to increased career development, women are increasingly delaying childbearing and, as a result, face declining biological fertility and increased maternal morbidity and adverse perinatal pregnancy outcomes, as well as increased use of ART. Preeclampsia (PE) complicates 2% of pregnancies and is a leading cause of severe maternal and perinatal complications. There is no curative treatment, and the only recognized beneficial primary prevention is low-dose aspirin. Finding an effective method of predicting and preventing placental dysfunction (PD) in women of advanced maternal age undergoing ART remains a challenge. The investigators believe that maternal and perinatal complications in this group of pregnant women could be detected preclinically and allow early preventive actions. On the other hand, establishing a differentiated genomic pattern in this group of patients would allow preventive actions both pregestational and during gestation. Furthermore, FORgenomics can be used to externally validate a prediction model for the development of PE and IUGR in pregnancy after IVF/ovodon. Our results could be applicable in most healthcare settings and have important implications for maternal-fetal health. The justification and hypothesis of this proposal is: (1) maternal and perinatal complications in this group of pregnant women could be detected preclinically and allow preventive actions by systematic screening based on Doppler ultrasound of uterine arteries and anti-angiogenic factors (sFlt-1/PlGF ratio) at 13, 16, 20 and 26 weeks to identify pregnant women at high risk for developing PE; (2) morphological ultrasound at 13, 16 and 20 weeks would help to establish a standardized procedure for early detection of congenital anomalies and (3) establishing a differentiated genomic pattern in this group of patients would allow preventive actions both pregestational and during gestation.

Conditions

• Preeclampsia
• Intrauterine Growth Restriction
• Placental Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Doppler ultrasound	Doppler ultrasound at 13, 16, 20 and 26 weeks for assessment of uterine arteries according to ISUOG criteria.
DIAGNOSTIC_TEST	Blood sample	Blood sampling at 13, 16, 20, 26 weeks of gestation to determine the sFlt-1/PlGF ratio
DIAGNOSTIC_TEST	Blood sample	Blood sampling at week 13 for DNA extraction for genomic studies
DIAGNOSTIC_TEST	Doppler ultrasound	Fetal morphological ultrasound at 13, 16 and 20 weeks.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-02-09
• Last updated: 2023-09-14