PRogrammed Versus Modified Natural Cycle After Euploid Failed Embryo

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06074055
Study type	Interventional
Source	Reproductive Medicine Associates of New Jersey
Contact	Caroline Zuckerman, BS, RN
Phone	19736562841
Email	clinicalresearchteam@ivirma.com
Status	Recruiting
Phase	N/A
Start date	October 25, 2023
Completion date	August 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PRogrammed Versus Modified Natural Cycle After Euploid Failed Embryo Transfer — PREFER

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms