FET Protocols for Infertility

(PREFER Trial)

Recruiting at 1 trial location

Overseen by Emre U Seli, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Reproductive Medicine Associates of New Jersey

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking all current medications. However, you must discontinue any adjunctive therapies for endometrial proliferation or receptivity, such as anticoagulation and antihistamines, upon enrollment.

What data supports the idea that FET Protocols for Infertility is an effective treatment?

The available research shows that FET Protocols for Infertility, particularly the modified natural cycle (mNC), may be more effective than other methods. Studies suggest that mNC protocols have higher success rates compared to natural cycle (NC) and artificial cycle (AC) protocols. For example, one study found that mNC protocols resulted in better outcomes for preparing the body for frozen embryo transfers. Another study indicated that mNC protocols might lead to more successful pregnancies and live births compared to artificial cycles. Overall, these findings suggest that FET Protocols, especially the modified natural cycle, are effective treatments for infertility. ^{1 2 3 4 5}

What safety data is available for FET Protocols for Infertility?

The provided research does not directly address safety data for FET Protocols for Infertility, such as Frozen Embryo Transfer or its variations. The studies focus on adverse event monitoring frameworks, national incidence of adverse events, and reporting practices for other medical treatments. Specific safety data for FET Protocols would require targeted studies or reviews in reproductive medicine literature. ^{6 7 8 9 10}

Is the FET Protocol a promising treatment for infertility?

The FET Protocol, which includes methods like Frozen Embryo Transfer and Natural Cycle FET, is considered a promising treatment for infertility. It offers a way to use embryos that have been frozen for later use, which can increase the chances of pregnancy. This approach allows for better timing and preparation of the body for embryo transfer, potentially leading to higher success rates in achieving pregnancy. ^{11 12 13 14 15}

Research Team

Emre U Seli, MD

Principal Investigator

Reproductive Medicine Associates of New Jersey

Eligibility Criteria

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.

Inclusion Criteria

My embryo was tested for genetic normality after January 1, 2017.

My recent tests show a normal uterus.

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

Exclusion Criteria

You had a previous failed fertility treatment that resulted in a lost pregnancy or pregnancy occurring outside the uterus.

Patients with an endometrial thickness < 7 mm prior to progesterone start in prior cycle

My embryo was tested before January 1, 2017.

Treatment Details

Interventions

• FET Protocol (Other)

Trial Overview 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.

Participant Groups

Group I: Programmed FET Protocol Experimental Treatment 1 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 Protocol Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Reproductive Medicine Associates of New Jersey

Lead Sponsor

Trials

56

Recruited

38,200+

Findings from Research

From 2013 to 2016, the incidence of adverse events (AEs) in Swedish hospitals decreased from 13.1% to an average of 11.4%, indicating improvements in patient safety during this period.

Preventable AEs were significantly more common (84% more) in patients cared for in inappropriate units ('off-site'), highlighting the importance of proper patient placement and the substantial economic burden of these events, which accounted for 13%-14% of total hospital care costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of adverse events in Sweden during 2013-2016: a cohort study describing the implementation of a national trigger tool. Nilsson, L., Borgstedt-Risberg, M., Soop, M., et al.[2019]

Follicular unit transplantation (FUT) is a highly refined hair restoration technique that uses microscopic dissection to transplant hair in natural groupings, resulting in outcomes that closely resemble natural hair growth.

FUT is recognized for providing natural-looking hairlines with good density and low recovery time, but the success of the procedure heavily relies on the skill and planning of the technician performing it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follicular unit transplantation. Rousso, DE., Presti, PM.[2008]

The two new hair transplant designs are reported to be safer than standard methods, potentially reducing the risk of complications during surgery.

These innovative designs aim to provide a more natural appearance for patients, enhancing the aesthetic outcomes of hair transplant procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair transplant surgery: innovative designs. Norwood, OT., Taylor, BJ.[2019]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Modified natural protocol seems superior to natural and artificial protocols for preparing the endometrium in frozen embryo transfer cycles. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Endometrial preparation methods prior to frozen embryo transfer: A retrospective cohort study comparing true natural cycle, modified natural cycle and artificial cycle. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Live birth after frozen-thawed embryo transfer: which endometrial preparation protocol is better? [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Modified natural cycle for embryo transfer using frozen-thawed blastocysts: A satisfactory option. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Natural cycle frozen embryo transfer: a survey of current assisted reproductive technology practices in the U.S. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Incidence of adverse events in Sweden during 2013-2016: a cohort study describing the implementation of a national trigger tool. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical outcome monitoring in a reproductive surgery unit: a prospective cohort study in 796 patients. [2009]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Mifepristone Adverse Events Identified by Planned Parenthood in 2009 and 2010 Compared to Those in the FDA Adverse Event Reporting System and Those Obtained Through the Freedom of Information Act. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Follicular unit transplantation. [2008]

12. United States pubmed.ncbi.nlm.nih.gov

Hair transplant surgery: innovative designs. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Recipient area hair direction and angle in hair transplanting. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Follicular unit transplantation: dissecting and planting techniques. [2006]

15. United States pubmed.ncbi.nlm.nih.gov

Old Friend or New Ally: A Comparison of Follicular Unit Transplantation and Follicular Unit Excision Methods in Hair Transplantation. [2021]