Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer

February 27, 2018 updated by: Buenaventura Coroleu, Institut Universitari Dexeus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

299

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Department of Obstetrics, Gynaecology and Reproduction Instituto Universitario Dexeus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

N/A

Genders 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®).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: Ten months after transfer procedure
Ten months after transfer procedure
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
Any pregnancy loss before week 20
Pregnancy rate
Time Frame: 6 weeks after transfer procedure
6 weeks after transfer procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 4, 2018

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMD-2018-01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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