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

NCT05960370 | Recruiting DMC

• 1 other identifier: Compaction Study
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility Due to Nonimplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Biochemical pregnancy loss

  9-10 days after the embryo transfer.

• Clinical pregnancy

  5-6 weeks gestational age.

• Ectopic pregnancy

  5-8 weeks gestational age.

• Early pregnancy loss

  5-10 weeks gestational age.

Study Arms (2)

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

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

Interventions

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.

exposed or "compaction" group; non-exposed "non-compaction" group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Women undergoing fertility treatment.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto Bernabeu: lead
• Universidad Miguel Hernandez de Elche: collaborator

Study Sites (1)

Instituto Bernabeu

Madrid, 28001, Spain

RECRUITING

Study Officials

• Juan Carlos J Castillo Farfan, Doctor

  Instituto Bernabeu Alicante

  STUDY DIRECTOR

Central Study Contacts

Esperanza E de la Torre Pérez, Gynecologist

CONTACT

+34625072082; espe_delatorre@hotmail.com

Juan Carlos J Castillo Farfan, Doctor

CONTACT

+34650562634; jcastillo@institutobernabeu.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologist

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: June 15, 2022
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)