Low Dose Acetylsalicylic Acid to Prevent Pre-eclampsia in Pregnant Women After Frozen Embryo Transfer: A Prospective Randomized Controlled Trial

What this Trial Is About

This research aims to evaluate the effect of low dose acetylsalicylic acid as a preventive treatment for pre-eclampsia in pregnant women who have undergone frozen embryo transfer. The study is a prospective, multicenter, interventional, randomized controlled trial designed to compare the incidence of pre-eclampsia between women treated with acetylsalicylic acid and those who are not. It includes women with natural, modified natural, or hormone replacement treatment (HRT) cycles who have a confirmed pregnancy at week 6 of amenorrhea. Participants will be randomly assigned to one of two groups: a treatment group receiving 160 mg of acetylsalicylic acid daily from embryo transfer until 36 weeks of amenorrhea, and a control group receiving no treatment. The study will monitor women in both groups with visits twice a month, including regular prenatal visits and phone calls. The trial will run up to delivery, with a maximum participant duration of 12 months, and overall study duration up to 4 years. During the study, participants will attend regular prenatal visits and receive phone follow-ups twice monthly. Researchers will monitor the occurrence of pre-eclampsia and miscarriage rates across different cycle types (natural, modified natural, and HRT). The primary outcome is the number of women developing pre-eclampsia in treated versus untreated groups. Safety and treatment adherence will be assessed throughout, and participants will be followed until delivery.

Treatment Preventive for Pre-eclampsia by Acetylsalicylic Acid in Women Who Underwent Frozen Embryo Transfer