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FET Protocols for Infertility (PREFER Trial)

N/A

Recruiting

Led By Emre U Seli, MD

Research Sponsored by Reproductive Medicine Associates of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have previously undergone their first unsuccessful frozen embryo transfer cycle, defined as either failure of implantation with negative pregnancy test or biochemical pregnancy, using a programmed cycle protocol

Patients ages 18 to 53 years old as per practice guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1-2 months post initial bhcg

Awards & highlights

PREFER Trial Summary

This trial will compare different frozen embryo transfer protocols to see if they improve pregnancy rates after a failed first FET cycle in infertility patients.

Who is the study for?

This trial is for women aged 18-53 with a BMI of 16-45 kg/m2 who have had one unsuccessful frozen embryo transfer (FET) using a programmed cycle. They must have at least one euploid blastocyst left, regular menstrual cycles or detectable LH surge, and an endometrial thickness ≥7 mm from the last cycle.Check my eligibility

What is being tested?

The study compares two FET protocols in patients needing a second attempt after an initial failure. Participants will be randomly assigned to either repeat the programmed protocol or switch to a modified natural protocol, assessing pregnancy outcomes and uterine flexibility.See study design

What are the potential side effects?

While specific side effects are not detailed for this trial, common risks may include discomfort from transvaginal ultrasounds and potential emotional distress due to varying success rates of embryo implantation.

PREFER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My first frozen embryo transfer did not result in a successful pregnancy.

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I am between 18 and 53 years old.

PREFER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1-2 months post initial bhcg

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1-2 months post initial bhcg

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1-2 months post initial bhcg for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sustained implantation rate

Secondary outcome measures

Biochemical Pregnancy Rate

Biochemical pregnancy loss rate

Clinical Pregnancy Loss Rate

+6 more

PREFER Trial Design

2Treatment groups

Experimental Treatment

Group I: Programmed FET ProtocolExperimental Treatment1 Intervention

Patients in this arm of the study will proceed with another programmed FET protocol which involves taking exogenous estrogen by mouth to stimulate the uterine lining to grow and develop. Once the lining has reached ≥ 7 mm and an endometrial pattern of type 1 or type 2, intramuscular progesterone in oil (50mg/ml daily) will be started at 8am on the morning that progesterone is initiated and continued per routine.

Group II: Modified Natural FET ProtocolExperimental Treatment1 Intervention

Following development of at least one dominant follicle and endometrial proliferation ≥ 7 mm during cycle monitoring, patient will undergo administration of human chorionic gonadotropin (hCG) trigger shot followed by initiation of vaginal progesterone administration in accordance with institutional protocols.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Reproductive Medicine Associates of New JerseyLead Sponsor

52 Previous Clinical Trials

37,054 Total Patients Enrolled

Emre U Seli, MDPrincipal InvestigatorReproductive Medicine Associates of New Jersey

1 Previous Clinical Trials

90 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to join the trial cohort?

"To qualify for this medical study, women aged 18 to 53 who experience infertility must apply. 760 participants are currently being sought after."

Answered by AI

Are there still openings available in this clinical experiment?

"The information available on clinicaltrials.gov does not indicate that this particular trial is actively searching for participants at the moment, as it was last updated on October 5th 2023. Despite this, there are still 259 other studies presently accepting patients into their program."

Answered by AI

Does this research encompass individuals who are over two decades old?

"This clinical trial necessitates that applicants be between 18 and 53 years old. For those below the age of consent or above retirement, there are 17 studies for minors and 38 for seniors, respectively."

Answered by AI