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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility Due to Nonimplantation
• Intervention / Treatment: Other: Observational non intervention study

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.

• Study Type: Observational
• Enrollment (Estimated): 206

Contacts and Locations

• Study Contact: Name: Esperanza E de la Torre Pérez, Gynecologist; Phone Number: +34625072082; Email: espe_delatorre@hotmail.com
• Study Contact Backup: Name: Juan Carlos J Castillo Farfan, Doctor; Phone Number: +34650562634; Email: jcastillo@institutobernabeu.com

Study Locations

• Spain
  • Madrid, Spain, 28001
    • Recruiting
    • Instituto Bernabeu
    • Contact: Esperanza E de la Torre Pérez, Gynecologist; Phone Number: +34625072082; Email: espe_delatorre@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
exposed or "compaction" group; 103 women with a decrease of ≥ 5% in endometrial thickness between the estrogenic phase (ovulation induction day) and the day of embryo transfer (7 days after ovulation induction).	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.
non-exposed "non-compaction" group; 103 women with similar or greater endometrial thickness between the estrogenic phase (ovulation induction day) and the day of embryo transfer (7 days after ovulation induction).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical pregnancy loss	Spontaneous pregnancy demise based on decreasing serum b-hCG levels, without an ultrasound evaluation.	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.	5-6 weeks gestational age.
Ectopic pregnancy	ultrasonic or surgical visualization of a pregnancy outside of the endometrial cavity.	5-8 weeks gestational age.
Early pregnancy loss	spontaneous pregnancy demise before 10 weeks of gestational age (before 8th developmental week).	5-10 weeks gestational age.

Collaborators and Investigators

• Sponsor: Instituto Bernabeu
• Collaborators: Universidad Miguel Hernandez de Elche
• Investigators: Study Director: Juan Carlos J Castillo Farfan, Doctor, Instituto Bernabeu Alicante

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: Compaction Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No