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

Infertility Due to Nonimplantation Clinical Trial

— Compaction  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05960370
• Other study ID #: Compaction Study
• Status: Recruiting
• Start date: June 15, 2022
• Est. completion date: October 15, 2024

Study information

• Verified date: July 2023
• Source: Instituto Bernabeu
• Contact: Esperanza E de la Torre Pérez, Gynecologist
• Phone: +34625072082
• Email: espe_delatorre[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: October 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infertility
• Infertility Due to Nonimplantation

Intervention

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.

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Bernabeu	Universidad Miguel Hernandez de Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	Presence of an intrauterine pregnancy with positive embryo heartbeat as seen by sonography at 8-10 weeks gestational age.	8-10 weeks gestational age.
Secondary	Biochemical pregnancy loss	Spontaneous pregnancy demise based on decreasing serum b-hCG levels, without an ultrasound evaluation.	9-10 days after the embryo transfer.
Secondary	Clinical pregnancy	A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy.	5-6 weeks gestational age.
Secondary	Ectopic pregnancy	ultrasonic or surgical visualization of a pregnancy outside of the endometrial cavity.	5-8 weeks gestational age.
Secondary	Early pregnancy loss	spontaneous pregnancy demise before 10 weeks of gestational age (before 8th developmental week).	5-10 weeks gestational age.