← Back to Search

Other

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

Must not have

PGT-A analysis of the available embryo for transfer performed prior to January 1, 2017

Anovulatory or oligo-ovulatory patients unable to undergo modified natural endometrial preparation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1-2 months post initial bhcg

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

I am between 18 and 53 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My embryo was tested before January 1, 2017.

Select...

I have irregular or no ovulation and cannot have a specific fertility treatment.

Select...

I have fibroids or need surgery for uterine issues.

Select...

I have a hydrosalpinx that won't be surgically treated before joining the study.

Select...

I have not agreed to join the study in writing.

Select...

My embryo for transfer was created using sperm obtained through surgery.

Select...

I do not have any normal embryos available for transfer.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sustained implantation rate

Secondary study objectives

Biochemical Pregnancy Rate

Biochemical pregnancy loss rate

Clinical Pregnancy Loss Rate

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility criteria met