NCT06074055

PRogrammed Versus Modified Natural Cycle After Euploid Failed Embryo Transfer

PREFER: PRogrammed Versus Modified Natural Cycle After Euploid Failed Embryo Transfer: A Randomized Control Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Reproductive Medicine Associates of New Jersey · Academic / Other
• Sex: Female
• Age: 18 Years – 53 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized clinical trial is to compare frozen embryo transfer protocols in patients undergoing a second frozen embryo transfer (FET) after a unsuccessful first programmed FET cycle as a possible treatment for people undergoing infertility treatment. The purpose of this research study is to: * Determine if there is a difference between FET protocols in patients who require a second FET cycle. * Investigate if switching the FET protocol after a failed programmed cycle is beneficial for patients undergoing a second FET cycle. * Examine pregnancy outcomes including obstetrical and neonatal outcomes (if applicable) * Obtain uterine flexibility/stiffness measurements via transvaginal ultrasound prior to the embryo transfer procedure. This is called shear wave elastography. Participants will be randomized in their second FET transfer attempt to either another programmed protocol or a modified natural protocol.

Detailed description

This research study is studying if there is a difference in frozen embryo transfer protocols used (modified natural versus programmed) after a failed first programmed FET cycle, defined as either a negative pregnancy test or a biochemical loss, as a possible treatment for people undergoing infertility treatment and in vitro fertilization (IVF). Participants will be randomized, in a 1:1 ratio, in their second FET transfer attempt to either another programmed protocol or a modified natural protocol. Once randomized, participants will undergo routine FET monitoring based on their randomization allocation, transfer procedure and pregnancy monitoring as applicable. Additional ultrasound images will be obtained prior to the transfer procedure to assess the stiffness or flexibility of the uterus, called shear wave elastography. A participant blood sample and infant buccal swab will be collected for future research studies.

Conditions

• Infertility, Female

Interventions

Type	Name	Description
OTHER	FET Protocol	Participants are randomized to either another programmed FET Protocol vs. a modified natural FET protocol

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-05-10
• Completion: 2024-10-21
• First posted: 2023-10-10
• Last updated: 2025-02-07

Locations

2 sites across 1 country: United States