NCT03558399

Brief Summary

To assess live birth after embryo transfer according to an individual's ERA results as opposed to routine protocol for frozen embryo transfer (FET) cycles.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
Last Updated

December 3, 2020

Status Verified

December 1, 2020

Enrollment Period

3.4 years

First QC Date

April 25, 2018

Last Update Submit

December 1, 2020

Conditions

Implantation FailureInfertility, Female

Keywords

Endometrial receptivity analysisWindow of implantationEuploidInfertility, FemaleImplantation failureFrozen embryo transfer FETERAWOIFETSynchrony

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure of this clinical trial is to assess live birth after euploid embryo transfer according to an individual's ERA result as opposed to routine protocol for frozen embryo transfer (FET) cycles.

    From date of randomization until live born infant at an estimated gestational age of at least 23 weeks or greater

Secondary Outcomes (4)

  • A secondary outcome measure of this clinical trial is to assess ongoing implantation rate after embryo transfer according to an individual's ERA result as opposed to routine protocol for frozen embryo transfer (FET) cycles.

    From date of randomization until 7-8 weeks estimated gestational age

  • A secondary outcome measure of this clinical trial is to assess implantation rate after embryo transfer according to an individual's ERA result as opposed to routine protocol for frozen embryo transfer (FET) cycles.

    From date of randomization until 5-6 weeks estimated gestational age

  • A secondary outcome measure of this clinical trial is to assess biochemical pregnancy after embryo transfer according to an individual's ERA result as opposed to routine protocol for frozen embryo transfer (FET) cycles.

    From date of randomization until ~10 days following embryo transfer

  • A secondary outcome measure of this clinical trial is to assess clinical pregnancy after embryo transfer according to an individual's ERA result as opposed to routine protocol for frozen embryo transfer (FET) cycles.

    From date of randomization until 5-7 weeks estimated gestational age

Study Arms (2)

FET according to ERA

EXPERIMENTAL

In preparation for frozen embryo transfer (FET), estradiol will be administered for approximately 10 to 14 days or until endometrial criteria are met. These endometrial criteria will be assessed with transvaginal ultrasound and serum estradiol levels. Women will then begin intramuscular progesterone injection and if assigned to the study arm, a single euploid embryo will be transferred at the time indicated by the ERA test results. Merely the timing of embryo transfer will distinguish the study from the control group.

Other: FET according to ERA

FET according to standard protocol

ACTIVE COMPARATOR

In preparation for frozen embryo transfer (FET), estradiol will be administered for approximately 10 to 14 days or until endometrial criteria are met. These endometrial criteria will be assessed with transvaginal ultrasound and serum estradiol levels. Women will then begin intramuscular progesterone injection and if assigned to the control arm, a single euploid embryo will be transferred according to our standard FET protocol.

Other: FET according to standard protocol

Interventions

FET according to ERAOTHER

Single euploid FET will be performed at the time indicated by the ERA test results.

FET according to ERA
FET according to standard protocolOTHER

Single euploid FET will be performed according to our standard FET protocol.

FET according to standard protocol

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly biological female subjects will be recruited for this study as an evaluation of the endometrium requires a uterus to be present and therefore this is only possible in the biological female sex.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent
  • Female age between 30 and 40 years and deemed likely by her physician, based on ovarian reserve testing, to produce at least one euploid blastocyst via one IVF/intracytoplasmatic sperm injection (ICSI) cycle
  • Having ≥ 1 euploid embryo available for embryo transfer
  • Standard eligibility criteria to undergo IVF and FET at Shady Grove Fertility Center.

You may not qualify if:

  • Known uterine factor impacting the endometrium
  • Use of surgically aspirated sperm for fertilization
  • Presence of any clinically relevant systemic disease that contraindicates assisted reproductive technology.
  • Since the subject last had a live birth (if any), there have been more than two embryo transfers that have not resulted in ongoing pregnancy
  • Body mass index \>40 kg/m2 at screening
  • Recurrent pregnancy loss, defined as two or more clinical pregnancy losses without live birth
  • Planned testing of embryos for single gene disorder(s) or structural chromosome rearrangements
  • Currently breast feeding, pregnant, or contraindication to pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shady Grove Fertility Reproductive Science Center

Rockville, Maryland, 20850, United States

Location

Related Publications (7)

  • Ruiz-Alonso M, Blesa D, Diaz-Gimeno P, Gomez E, Fernandez-Sanchez M, Carranza F, Carrera J, Vilella F, Pellicer A, Simon C. The endometrial receptivity array for diagnosis and personalized embryo transfer as a treatment for patients with repeated implantation failure. Fertil Steril. 2013 Sep;100(3):818-24. doi: 10.1016/j.fertnstert.2013.05.004. Epub 2013 Jun 4.

    PMID: 23756099BACKGROUND

  • Katzorke N, Vilella F, Ruiz M, Krussel JS, Simon C. Diagnosis of Endometrial-Factor Infertility: Current Approaches and New Avenues for Research. Geburtshilfe Frauenheilkd. 2016 Jun;76(6):699-703. doi: 10.1055/s-0042-103752.

    PMID: 27365540BACKGROUND

  • Horcajadas JA, Pellicer A, Simon C. Wide genomic analysis of human endometrial receptivity: new times, new opportunities. Hum Reprod Update. 2007 Jan-Feb;13(1):77-86. doi: 10.1093/humupd/dml046. Epub 2006 Sep 7.

    PMID: 16960016BACKGROUND

  • Ponnampalam AP, Weston GC, Trajstman AC, Susil B, Rogers PA. Molecular classification of human endometrial cycle stages by transcriptional profiling. Mol Hum Reprod. 2004 Dec;10(12):879-93. doi: 10.1093/molehr/gah121. Epub 2004 Oct 22.

    PMID: 15501903BACKGROUND

  • Galliano D, Pellicer A. MicroRNA and implantation. Fertil Steril. 2014 Jun;101(6):1531-44. doi: 10.1016/j.fertnstert.2014.04.023.

    PMID: 24882617BACKGROUND

  • Ruiz-Alonso M, Blesa D, Simon C. The genomics of the human endometrium. Biochim Biophys Acta. 2012 Dec;1822(12):1931-42. doi: 10.1016/j.bbadis.2012.05.004. Epub 2012 May 24.

    PMID: 22634130BACKGROUND

  • Doyle N, Jahandideh S, Hill MJ, Widra EA, Levy M, Devine K. Effect of Timing by Endometrial Receptivity Testing vs Standard Timing of Frozen Embryo Transfer on Live Birth in Patients Undergoing In Vitro Fertilization: A Randomized Clinical Trial. JAMA. 2022 Dec 6;328(21):2117-2125. doi: 10.1001/jama.2022.20438.

    PMID: 36472596DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Kathleen Devine, MD

    Shady Grove Fertility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Results of the ERA analysis will not be disclosed to the patient or the physician or the outcome assessor, nor will the study arm to which the patient was assigned, though the patient/physician may be able to intuit assignment to the ERA arm based on the frozen embryo transfer time that she is assigned. The date and time of embryo transfer will be provided by the investigator/research team.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

June 15, 2018

Study Start

April 25, 2018

Primary Completion

September 23, 2021

Study Completion

September 23, 2021

Last Updated

December 3, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)