Natural Versus Programmed Frozen Embryo Transfer (NatPro) (NatPro)

STATUS

Recruiting
End date

Sep 30, 2024
participants needed

788
sponsor

JHSPH Center for Clinical Trials

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Updated on 4 October 2022

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diabetes

body mass index

progesterone

Accepts healthy volunteers

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).

Description

NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing FET will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent). The study will implement a stratified randomization design to balance the use of pre-implantation genetic testing (PGT) across the two treatment arms. Each participant will have up to 3 FET cycles until live birth occurs, or the participant has no embryos available for transfer. Primary endpoints will be the proportion of women experiencing preeclampsia comparing modified natural to programmed FET among women with viable pregnancy (defined as pregnancy lasting at least 20 weeks) and the cumulative proportion of women having live births in the two arms.

Details

Condition	Pregnancy Related, Pre-Eclampsia
Treatment	Modified natural cycle, Programmed cycle
Clinical Study Identifier	NCT04551807
Sponsor	JHSPH Center for Clinical Trials
Last Modified on	4 October 2022

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Eligibility		Yes	No	Not Sure
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
	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 per the site director), within one year of study enrollment and repeated at the discretion of the investigator. Use of thyroid medication is permitted
Exclusion Criteria
	To be eligible, subjects must not meet any one of these criteria
	Medical contraindication to pregnancy
	Embryos created using donor oocytes
	Embryo donation
	Gestational carrier
	Reciprocal IVF (one female partner carrying pregnancy, other female partner as source of eggs)
	Fresh embryos created from frozen oocytes. Patients with frozen embryos created from frozen oocytes can be included
	Recurrent implantation failure defined as no clinical pregnancy with ≥ 2 prior consecutive embryo transfers unless patient also had successful live birth between or after the failed embryo transfers
	Anti-phospholipid antibody syndrome or rheumatologic disease requiring chronic systemic medications
	Uncontrolled diabetes mellitus
	History of >1 pregnancy loss in the second or third trimester
	Uncontrolled hypertension
	Untreated hydrosalpinx (i.e., hydrosalpinx in situ which has not been ligated or removed)
	Physician recommendation to perform the embryo transfer outside of the timing specified by the protocol
	Mullerian uterine anomaly, if not correctable
	Contraindication to any medication which must be used in preparation for the frozen embryo transfer (i.e., estradiol, progesterone, hCG)

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Natural Versus Programmed Frozen Embryo Transfer (NatPro) (NatPro)