Infertility, FemalePREFERNCT06074055
PRogrammed Versus Modified Natural Cycle After Euploid Failed Embryo Transfer
A study testing FET Protocol in people with Infertility, Female, run by Reproductive Medicine Associates of New Jersey at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 53 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- FET Protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Oct 2023to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 53 years
- Women only
- No healthy volunteers
- Adult
Major Inclusion Criteria: The following are major inclusion criteria:
- Patients planning to undergo frozen embryo transfer cycle with a single euploid blastocyst.
- 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.
- Preimplantation genetic testing for aneuploidy (PGT-A) of the embryo used in failed programmed embryo transfer cycle must have occurred after January 1, 2017.
- Patients ages 18 to 53 years old as per practice guidelines.
- Patients with BMI between 16-45 kg/m2.
- Patients with at least one embryo remaining in storage, from either the same or a separate cohort.
- Patients with proven ovulatory function, as defined by the presence of regular menstrual cycles or detection of luteinizing hormone surge on serum or urinary test kits.
- Patients with ≥ 7 mm endometrial thickness prior to progesterone start in prior transfer cycle.
- Normal uterine cavity as evidenced by recent (within 1 year) saline sonogram or hysteroscopy.
Major Exclusion Criteria: The following are exclusion criteria:
- More than 1 prior unsuccessful frozen embryo transfer cycle.
- The prior FET failure having had resulted in a clinical loss or ectopic pregnancy
- Previously cancelled frozen embryo transfer cycle for inadequate endometrial response.
- Patients who required a different route of estrogen administration in the prior programmed cycle (vaginal, transdermal, intramuscular).
- 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.
- Patients with an endometrial thickness < 7 mm prior to progesterone start in prior cycle.
- History of hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, and eclampsia.
- Mullerian anomalies, excluding arcuate uterus and repaired septum.
- No euploid embryos available for transfer.
- Concurrent submucosal fibroids, unrepaired uterine defects or present indication for uterine surgery.
- Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
- Failure of patient to agree to enrollment in study with written consent.
- Concurrent pregnancy.
- Concomitant use of adjunctive therapies for endometrial proliferation or receptivity, including anticoagulation and antihistamines. These must be discontinued upon enrollment.
- Embryo planned to be used for transfer generated from surgically obtained sperm.
- Recurrent/persistent endometrial fluid in prior cycles visualized on the majority of transvaginal ultrasound monitoring.
- Third party reproduction patients (donor sperm sources can be included).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
Reproductive Medicine Associates of New Jersey
Marlton, New Jersey, 08053
About this study
Official title: PREFER: PRogrammed Versus Modified Natural Cycle After Euploid Failed Embryo Transfer: A Randomized Control 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:
Read more
- 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.
Read the 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
- Being tested
- FET Protocol
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FET ProtocolOther
Participants are randomized to either another programmed FET Protocol vs. a modified natural FET protocol
| Study group | Role | What they receive |
|---|---|---|
| Programmed FET Protocol | Other | 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. Receives: Other: FET Protocol |
| Modified Natural FET Protocol | Other | 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. Receives: Other: FET Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained implantation rate
presence of an intrauterine clinical pregnancy with fetal heart tones at 8 weeks gestational age
Measured: approximately 6 weeks after embryo transfer
Secondary outcomes (9)
Biochemical Pregnancy Rate
Biochemical (positive serum beta human chorionic gonadotropin (bHCG) post transfer procedure)
Measured: approximately 9 days after transfer
Biochemical pregnancy loss rate
serum bHCG level ≥ 5 milli-International unit (mIU/mL) after FET without any ultrasound evidence of pregnancy until serum bHCG is < 5 mIU/mL
Measured: typically 1 month post initial bHCG test
Clinical Pregnancy Rate
presence of an intrauterine gestational sac
Measured: approximately 10 days after initial pregnancy test
Clinical Pregnancy Loss Rate
a pregnancy after FET that had at minimum ultrasound evidence of a gestational sac, but did not progress to a live birth and was not terminated nor was an ectopic pregnancy.
Measured: approximately 2 months after FET procedure
Live Birth Rate
delivery of a live born infant greater than 24 weeks gestational age.
Measured: approximately 16-32 weeks post discharge at 8 weeks gestational age
Rate of pregnancies of undetermined location and ectopic pregnancies
Pregnancies that are not intrauterine
Measured: approximately 1-2 months post initial bHCG
Rate of maternal obstetrical outcomes and complications
mode of delivery, placental issues, preterm delivery
Measured: approximately 40 weeks gestation
Rate of neonatal outcomes and complications
gestational age at delivery, birth weight, any complications
Measured: approximately 40 weeks gestational age or after delivery of infant
Elastography Data
shear wave elastography measurements of the uterus
Measured: prior to the embryo transfer procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start25 Oct 2023
- Primary completion10 May 2024
- Study completion21 Oct 2024
Why it stopped: recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emre U Seli, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074055
- Sponsor's protocol ID
- 2302-BRG-024-ES
- Acronym
- PREFER
- Status last verified
- Feb 2025
- First submitted
- 20 Sep 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREFER: PRogrammed Versus Modified Natural Cycle After Euploid Failed Embryo Transfer: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06074055
- Acronym / sponsor ID
- PREFER / 2302-BRG-024-ES
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment issues
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Programmed FET Protocol | Other | Other: FET ProtocolPatients 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. |
| Modified Natural FET Protocol | Other | Other: FET ProtocolFollowing 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 may qualify
- Ages
- 18 to 53 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FET ProtocolParticipants are randomized to either another programmed FET Protocol vs. a modified natural FET protocol | Other | Modified Natural FET Protocol, Programmed FET Protocol |
Primary outcome
Sustained implantation rate
Time frame: approximately 6 weeks after embryo transfer
presence of an intrauterine clinical pregnancy with fetal heart tones at 8 weeks gestational age
9 secondary outcomes
Biochemical Pregnancy Rate
Time frame: approximately 9 days after transfer
Biochemical pregnancy loss rate
Time frame: typically 1 month post initial bHCG test
Clinical Pregnancy Rate
Time frame: approximately 10 days after initial pregnancy test
Clinical Pregnancy Loss Rate
Time frame: approximately 2 months after FET procedure
Live Birth Rate
Time frame: approximately 16-32 weeks post discharge at 8 weeks gestational age
Rate of pregnancies of undetermined location and ectopic pregnancies
Time frame: approximately 1-2 months post initial bHCG
Rate of maternal obstetrical outcomes and complications
Time frame: approximately 40 weeks gestation
Rate of neonatal outcomes and complications
Time frame: approximately 40 weeks gestational age or after delivery of infant
Elastography Data
Time frame: prior to the embryo transfer procedure
Results and safety
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emre U Seli, MD principal investigator
Reproductive Medicine Associates of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FET Protocol in people with Infertility, Female, run by Reproductive Medicine Associates of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained implantation rate (time frame: approximately 6 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.