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NCT Number: NCT05960370

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Instituto Bernabeu

Madrid, 28001, Spain

Location status: Recruiting

Location contact

Esperanza E de la Torre Pérez, Gynecologist

CONTACT

[email protected]

+34625072082

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Observational non intervention study

Other

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.

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: 8-10 weeks gestational age.

    Presence of an intrauterine pregnancy with positive embryo heartbeat as seen by sonography at 8-10 weeks gestational age.

Secondary outcomes

  1. Biochemical pregnancy loss

    Time frame: 9-10 days after the embryo transfer.

    Spontaneous pregnancy demise based on decreasing serum b-hCG levels, without an ultrasound evaluation.

  2. Clinical pregnancy

    Time frame: 5-6 weeks gestational age.

    A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy.

  3. Ectopic pregnancy

    Time frame: 5-8 weeks gestational age.

    ultrasonic or surgical visualization of a pregnancy outside of the endometrial cavity.

  4. Early pregnancy loss

    Time frame: 5-10 weeks gestational age.

    spontaneous pregnancy demise before 10 weeks of gestational age (before 8th developmental week).

Study contacts

Contact information is provided by the study sponsor or research team.

Esperanza E de la Torre Pérez, Gynecologist

CONTACT

[email protected]

+34625072082

Juan Carlos J Castillo Farfan, Doctor

CONTACT

[email protected]

+34650562634

Sponsors and collaborators

Lead sponsor

Instituto Bernabeu

Other

Collaborators

  • Universidad Miguel Hernandez de Elche

Registry information

Official study title

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

Acronym: Compaction

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2023
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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