NCT05960370

Impact of Endometrial Compaction on Reproductive Outcomes After Cryotransfer of Euploid Embryos in a Natural Cycle

Impact of Endometrial Compaction on Reproductive Outcomes After Cryotransfer of Euploid Embryos in a Natural Cycle: Prospective Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 206 (estimated)
• Sponsor: Instituto Bernabeu · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Infertility Due to Nonimplantation

Interventions

Type	Name	Description
OTHER	Observational non intervention study	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.

Timeline

• Start date: 2022-06-15
• Primary completion: 2025-06-15
• Completion: 2025-06-15
• First posted: 2023-07-25
• Last updated: 2024-10-03

Locations

1 site across 1 country: Spain