Clinical trial NCT05960370: Impact of Endometrial Compaction on Reproductive Outcomes After Cryotransfer of Euploid Embryos in a Natural Cycle
Official title: Impact of Endometrial Compaction on Reproductive Outcomes After Cryotransfer of Euploid Embryos in a Natural Cycle: Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility Due to Nonimplantation
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
Collaborators: name: Universidad Miguel Hernandez de Elche
First posted: 2023-07-25
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 206 Women between 18-50 years, with primary or secondary infertility, undergoing fertility treatment that includes endometrial preparation in a modified natural cycle for transfer of previously analyzed frozen and euploid embryos.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18 to 50 years
* Primary or secondary infertility
* Normal uterine cavity
* Endometrial preparation in a modified natural cycle for single embryo transfer
* Embryo in blastocyst state from own oocyte or oocyte donation cycles, who had normal results on preimplantation genetic testing for aneuploidy (PGT-A) via trophectoderm biopsy.

Exclusion Criteria:

* Uterine or endometrial disease (multiple myomatosis \[\>3 fibroids of \> 3 cm\], adenomyosis, Asherman syndrome)
* Difficulties in correctly measuring endometrial thickness due to a retroverted or tilted uterus
* History of recurrent implantation failure (3 or more transferred blastocysts of good quality, from their own oocyte \[\<35 years\] or oocyte donation); recurrent early Pregnancy Loss (the loss of two or more pregnancies before 10 weeks of gestational age.
* Suboptimal endometrial response (endometrium \< 6 mm on the day of ovulation triggering).

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 8-10 weeks gestational age.
Secondary outcomes:
measure: Biochemical pregnancy loss
timeFrame: 9-10 days after the embryo transfer.
measure: Clinical pregnancy
timeFrame: 5-6 weeks gestational age.
measure: Ectopic pregnancy
timeFrame: 5-8 weeks gestational age.
measure: Early pregnancy loss
timeFrame: 5-10 weeks gestational age.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Bernabeu
Study officials:
affiliation: Instituto Bernabeu Alicante
name: Juan Carlos J Castillo Farfan, Doctor
role: STUDY_DIRECTOR
References: