Infertility, Female
Conditions
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 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.
Interventions
OTHERFET Protocol
Participants are randomized to either another programmed FET Protocol vs. a modified natural FET protocol
Sponsors
Reproductive Medicine Associates of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 53 Years
Healthy volunteers
No
Inclusion criteria
Major Inclusion Criteria: The following are major inclusion criteria: 1. Patients planning to undergo frozen embryo transfer cycle with a single euploid blastocyst. 2. 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. 3. Preimplantation genetic testing for aneuploidy (PGT-A) of the embryo used in failed programmed embryo transfer cycle must have occurred after January 1, 2017. 4. Patients ages 18 to 53 years old as per practice guidelines. 5. Patients with BMI between 16-45 kg/m2. 6. Patients with at least one embryo remaining in storage, from either the same or a separate cohort. 7. 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. 8. Patients with ≥ 7 mm endometrial thickness prior to progesterone start in prior transfer cycle. 9. Normal uterine cavity as evidenced by recent (within 1 year) saline sonogram or hysteroscopy. Major
Exclusion criteria
The following are
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained implantation rate | approximately 6 weeks after embryo transfer | presence of an intrauterine clinical pregnancy with fetal heart tones at 8 weeks gestational age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy loss rate | typically 1 month post initial bHCG test | serum bHCG level ≥ 5 milli-International unit (mIU/mL) after FET without any ultrasound evidence of pregnancy until serum bHCG is \< 5 mIU/mL |
| Clinical Pregnancy Rate | approximately 10 days after initial pregnancy test | presence of an intrauterine gestational sac |
| Clinical Pregnancy Loss Rate | approximately 2 months after FET procedure | 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. |
| Live Birth Rate | approximately 16-32 weeks post discharge at 8 weeks gestational age | delivery of a live born infant greater than 24 weeks gestational age. |
| Biochemical Pregnancy Rate | approximately 9 days after transfer | Biochemical (positive serum beta human chorionic gonadotropin (bHCG) post transfer procedure) |
| Rate of maternal obstetrical outcomes and complications | approximately 40 weeks gestation | mode of delivery, placental issues, preterm delivery |
| Rate of neonatal outcomes and complications | approximately 40 weeks gestational age or after delivery of infant | gestational age at delivery, birth weight, any complications |
| Elastography Data | prior to the embryo transfer procedure | shear wave elastography measurements of the uterus |
| Rate of pregnancies of undetermined location and ectopic pregnancies | approximately 1-2 months post initial bHCG | Pregnancies that are not intrauterine |
Countries
United States
Outcome results
None listed