Natural Versus Programmed Frozen Embryo Transfer (NatPro) (NCT04551807) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Natural Versus Programmed Frozen Embryo Transfer (NatPro)
United States788 participantsStarted 2020-09-16
Plain-language summary
NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing frozen embryo transfer (FET) will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent).
Who can participate
Age range18 Years – 41 Years
SexFEMALE
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Inclusion criteria
To be eligible, subjects must meet all these criteria:
* Age 18-39 years at the time that embryos were created if no PGT testing was performed. If PGT testing was performed and indicates that an embryo is euploid, the patient can be included if she was age 18-41 years at the time that the embryo was created.
* Age 18-41 years at the time of randomization as advancing age itself becomes a significant risk for preeclampsia
* Normal uterine cavity as assessed by saline infusion sonohysterogram, hysterosalpingogram, or hysteroscopy within one year of the enrollment visit, and repeated at the discretion of the investigator
* Regular menstrual cycle length (approximately 24-35 days) indicative of ovulatory cycles.
* Willing to undergo elective single embryo transfer
* Body Mass Index \<=40
* If Body Mass Index is over 30 or individual has other risk factors for diabetes, normal hemoglobin A1C
* Prior to enrollment, participant will have at least one vitrified blastocyst with euploid result by pre-implantation genetic testing (PGT-A) or at least one vitrified blastocyst of fair or better morphologic quality if no PGT-A results are available.
* Willingness to be randomized to either a modified natural or programmed cycle, with a willingness to administer intramuscular progesterone in oil if assigned to the programmed cycle.
* Normal thyroid stimulating hormone (TSH), according to local laboratory standards (or TSH level with a clinically insignificant abnormality…
What they're measuring
1
Preeclampsia
Timeframe: During pregnancy through the post-partum period, according to ACOG guidelines (typically between 20 weeks gestation and 6 weeks post-delivery)