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OpenTrials
Completed

NCT Number: NCT03395665

Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer

The development and improvement in Preimplantation genetic diagnosis/screening (PGS) in association with the efficacy and security of vitrification and trophectoderm biopsy, more efficient stimulation schemes and laboratory improvements in culture and embryo selection have contributed to high success of the assisted reproductive technologies(ART). Transferring an euploid embryo avoids one of the main reasons of miscarriage and implantation failure ( Rubio et al, 22016) and overcomes one of the most important confounding factors. Usually, the transfer of euploid embryos is performed under standard hormone replacement therapy (HRT) and are referred to as FET-PGS cycles( Frozen embryo transfer). The study of FET-PGS cycles with the transfer of a single euploid blastocyst is the best model for evaluation of the impact of the endometrial preparation . Among factors influencing FET outcomes, patient's age, endometrial preparation, endometrium thickness, endometrial pattern, number and quality of embryos transferred , difficulty at ET, recently P4 have received more attention .

The importance of Progesterone (P4) in embryo implantation has been widely studied. P4 plays an important role in endometrial gland formation, embryonic implantation and pregnancy maintenance, both in natural and artificial cycles.

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Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics, Gynaecology and Reproduction Instituto Universitario Dexeus

Barcelona, 08028, Spain

Who can participate

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

Inclusion criteria

  • Frozen embryo transfer (FET) of at least one single euploid embryo.
  • Estradiol > 75pg/ml.
  • Progesterone > 4 ng/ml.
  • Endometrial thickness between 6 mm and 18 mm.

Exclusion criteria

  • Patients with FET of no diagnostic or mosaic embryos, or known uterine abnormality were excluded.
  • Natura cycle protocol.

Treatment and study plan

Estradiol level

Other

Estradiol level measured at previous day of embryo transfer procedure

Progesterone level

Other

Progesterone level measured at previous day of embryo transfer procedure

Endometrial thickness

Other

Endometrial thickness measured at previous day of embryo transfer procedure

Primary outcomes

  1. Live birth rate

    Time frame: Ten months after transfer procedure

  2. Miscarriage rate

    Time frame: Any pregnancy loss before week 20

    Miscarriage was defined as a loss following a positive pregnancy test and/or detectable Gestational sac

  3. Pregnancy rate

    Time frame: 6 weeks after transfer procedure

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jan 10, 2018
Registry last updated
Feb 28, 2018

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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