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Trial record 4 of 358 for:    genital diseases AND (woman OR women OR female) AND live birth

Frozen Blastocyst Transfer Using Conventional Timing Versus Timing by Endometrial Receptivity Analysis (Synchrony)

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ClinicalTrials.gov Identifier: NCT03558399
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
Igenomix
Information provided by (Responsible Party):
Shady Grove Fertility Reproductive Science Center

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.

Condition or disease Intervention/treatment Phase
Implantation Failure Infertility, Female Other: FET according to ERA Other: FET according to standard protocol Not Applicable

Detailed Description:

It has been proposed, that the receptivity status of the endometrium shifts among individual women and that repeated implantation failure is ascribable to an endometrial factor in up to 25%. The endometrial receptivity analysis (ERA) is a diagnostic method that was developed based on the unique genomic signature of the endometrium during the window of implantation and classifies the endometrium as receptive, pre-receptive or post-receptive to guide embryo transfer.

The purpose of this assessor-blind, randomized clinical study is to determine whether live birth from vitrified/thawed euploid embryo transfer is improved when transfer is timed according to endometrial receptivity analysis (ERA) results.

Approximately 800 women (n=400 in each arm) will be enrolled according to the inclusion/exclusion criteria among patients of Shady Grove Fertility. Participants will undergo a standard in vitro fertilization (IVF) cycle, followed by preimplantation genetic screening (PGS) provided a high quality blastocyst is available. Participants with at least one PGS normal (euploid) embryo will be randomized (assigned by chance, like the flip of a coin) to one of two study groups. Women in both study arms will then undergo ERA testing and neither the patients nor their treating physicians will know to which group the women have been assigned to, or the ERA testing results. Up until this point there is no difference between the study and control group. The investigational aspect of this trial is described as follows: If the participant is assigned to the study arm, the single, euploid, frozen embryo transfer (FET) during the subsequent cycle will be performed at the time indicated by the ERA test results. If she is in the control arm, the embryo will be transferred according to our standard FET protocol.

Patients enrolling in the study will receive PGS and ERA free of charge.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Trial Comparing Live Birth From Single, Euploid Frozen Blastocyst Transfer Using Conventional Timing Versus Timing by Endometrial Receptivity Analysis
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : September 23, 2019
Estimated Study Completion Date : August 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FET according to ERA
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
Single euploid FET will be performed at the time indicated by the ERA test results.

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




Primary Outcome Measures :
  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. [ Time Frame: From date of randomization until live born infant at an estimated gestational age of at least 23 weeks or greater ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: From date of randomization until 7-8 weeks estimated gestational age ]
    The ongoing implantation rate is defined as maximum number of fetal heartbeats divided by total number of embryos transferred

  2. 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. [ Time Frame: From date of randomization until 5-6 weeks estimated gestational age ]
    The implantation rate is defined as the maximum number of gestational sacs per patient

  3. 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. [ Time Frame: From date of randomization until ~10 days following embryo transfer ]
    Biochemical pregnancy is defined as detection of beta hCG above 5 IU/L

  4. 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. [ Time Frame: From date of randomization until 5-7 weeks estimated gestational age ]
    The clinical pregnancy rate is defined as the presence of gestational sacs



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only 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.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. 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
  3. Having ≥ 1 euploid embryo available for embryo transfer
  4. Standard eligibility criteria to undergo IVF and FET at Shady Grove Fertility Center.

Exclusion Criteria:

  1. Known uterine factor impacting the endometrium
  2. Use of surgically aspirated sperm for fertilization
  3. Presence of any clinically relevant systemic disease that contraindicates assisted reproductive technology.
  4. 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
  5. Body mass index >40 kg/m2 at screening
  6. Recurrent pregnancy loss, defined as two or more clinical pregnancy losses without live birth
  7. Planned testing of embryos for single gene disorder(s) or structural chromosome rearrangements
  8. Currently breast feeding, pregnant, or contraindication to pregnancy

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): NCT03558399


Contacts
Contact: Kathleen Devine, MD (301) 340-1188 kate.devine@integramed.com
Contact: Nicole Doyle, MD (888) 420-3329 nicole.doyle@nih.gov

Locations
United States, Maryland
Shady Grove Fertility Reproductive Science Center Recruiting
Rockville, Maryland, United States, 20850
Contact: Kathleen Devine, MD    301-340-1188    kate.devine@integramed.com   
Sponsors and Collaborators
Shady Grove Fertility Reproductive Science Center
Igenomix
Investigators
Principal Investigator: Kathleen Devine, MD Shady Grove Fertility

Publications:
Responsible Party: Shady Grove Fertility Reproductive Science Center
ClinicalTrials.gov Identifier: NCT03558399     History of Changes
Other Study ID Numbers: 1183343
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shady Grove Fertility Reproductive Science Center:
Endometrial receptivity analysis
Window of implantation
Euploid
Infertility, Female
Implantation failure
Frozen embryo transfer FET
ERA
WOI
FET
Synchrony

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female