NCT03558399

Frozen Blastocyst Transfer Using Conventional Timing Versus Timing by Endometrial Receptivity Analysis

A Randomized Controlled Trial Comparing Live Birth From Single, Euploid Frozen Blastocyst Transfer Using Conventional Timing Versus Timing by Endometrial Receptivity Analysis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Shady Grove Fertility Reproductive Science Center · Academic / Other
• Sex: Female
• Age: 30 Years – 40 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Implantation Failure
• Infertility, Female

Interventions

Type	Name	Description
OTHER	FET according to ERA	Single euploid FET will be performed at the time indicated by the ERA test results.
OTHER	FET according to standard protocol	Single euploid FET will be performed according to our standard FET protocol.

Timeline

• Start date: 2018-04-25
• Primary completion: 2021-09-23
• Completion: 2021-09-23
• First posted: 2018-06-15
• Last updated: 2020-12-03

Locations

1 site across 1 country: United States