Status:
TERMINATED
PRogrammed Versus Modified Natural Cycle After Euploid Failed Embryo Transfer
Lead Sponsor:
Reproductive Medicine Associates of New Jersey
Conditions:
Infertility, Female
Eligibility:
FEMALE
18-53 years
Phase:
NA
Brief 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 a...
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 ne...
Eligibility Criteria
Inclusion
- Major 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
- 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).
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06074055
Start Date
October 25 2023
End Date
October 21 2024
Last Update
February 7 2025
Active Locations (2)
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1
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
2
Reproductive Medicine Associates of New Jersey
Marlton, New Jersey, United States, 08053