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Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer

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ClinicalTrials.gov Identifier: NCT03395665
Recruitment Status : Completed
First Posted : January 10, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Buenaventura Coroleu, Institut Universitari Dexeus

Brief Summary:

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.


Condition or disease Intervention/treatment
Infertility Preimplantation Genetic Diagnosis/Screening Miscarriage Other: Estradiol level Other: Progesterone level Other: Endometrial thickness

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Study Type : Observational
Actual Enrollment : 299 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer
Actual Study Start Date : January 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018



Intervention Details:
  • Other: Estradiol level
    Estradiol level measured at previous day of embryo transfer procedure
  • Other: Progesterone level
    Progesterone level measured at previous day of embryo transfer procedure
  • Other: Endometrial thickness
    Endometrial thickness measured at previous day of embryo transfer procedure


Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population

Women who underwent blastocyst trophectoderm biopsy and PGS and frozen-thawed embryo transfers(PGS-FET) performed after the In Vitro Fertilization (IVF) .

PGS was implemented as 46-chromosome screening, using array comparative genomic hybridization (aCGH) from Day 5 trophectoderm biopsy. Whole-genome amplification, processing and analyses were performed using the kits, software and protocols for array Comparative Genomic Hybridisation (aCGH) analysis provided by the manufacturer (SurePlex® DNA Amplification System, 24Sure® Microarray Pack, Bluefuse®, Illlumina®).

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395665


Locations
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Spain
Department of Obstetrics, Gynaecology and Reproduction Instituto Universitario Dexeus
Barcelona, Spain, 08028
Sponsors and Collaborators
Institut Universitari Dexeus
Additional Information:
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Responsible Party: Buenaventura Coroleu, Head of Reproductive Medicine Service, Institut Universitari Dexeus
ClinicalTrials.gov Identifier: NCT03395665    
Other Study ID Numbers: SMD-2018-01
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Abortion, Spontaneous
Genital Diseases, Male
Genital Diseases, Female
Pregnancy Complications
Estradiol
Progesterone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins