Multicenter prospective observational cohort study, comparing ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of the transfer versus those who have a stable or greater endometrial thickness with respect to the estrogenic phase.
Multicenter prospective observational cohort study. Based on our sample size calculation, the study group will consist of 206 women (exposed or "compaction" group: 103 women with a decrease of ≥ 5% in endometrial thickness between the estrogenic phase and the day of embryo transfer; non-exposed "non-compaction" group: 103 women with similar or greater endometrial thickness between these time points). The main objective of this study is to compare the ongoing pregnancy rates in natural cycles for euploid embryo transfer in patients who present endometrial compaction at the time of transfer versus those who with a stable or greater endometrial thickness with respect to the estrogenic phase. The estimated duration of the study is 24-30 months. Inclusion criteria are: 18 to 50 years of age, with primary or secondary infertility, subjected to endometrial preparation in a modified natural cycle for transfer of a genetically euploid blastocyst, from their own oocyte or oocyte donation, with a normal uterine cavity. Exclusion criteria are: uterine or endometrial disease (e.g., multiple myomatosis, severe adenomyosis, Asherman syndrome, refractory endometrium), conditions that prevent correct ultrasound assessment (tilted uterus), or a history of recurrent implantation failure or repeated miscarriages.
Study Type
OBSERVATIONAL
Enrollment
206
An additional control scan will be performed vaginally the day of the embryo transfer. Rest of follow up and treatment will be executed as usually.
Instituto Bernabeu
Madrid, Spain
RECRUITINGOngoing pregnancy rate
Presence of an intrauterine pregnancy with positive embryo heartbeat as seen by sonography at 8-10 weeks gestational age.
Time frame: 8-10 weeks gestational age.
Biochemical pregnancy loss
Spontaneous pregnancy demise based on decreasing serum b-hCG levels, without an ultrasound evaluation.
Time frame: 9-10 days after the embryo transfer.
Clinical pregnancy
A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy.
Time frame: 5-6 weeks gestational age.
Ectopic pregnancy
ultrasonic or surgical visualization of a pregnancy outside of the endometrial cavity.
Time frame: 5-8 weeks gestational age.
Early pregnancy loss
spontaneous pregnancy demise before 10 weeks of gestational age (before 8th developmental week).
Time frame: 5-10 weeks gestational age.
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