Summary

Eligibility
for females ages 18-41 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Marcelle Cedars, MD
Headshot of Marcelle Cedars
Marcelle Cedars

Description

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).

Official Title

Multi-center, Parallel-group, Randomized Controlled Trial of Modified Natural Versus Programmed Cycles for Frozen Embryo Transfers and Their Association With Preeclampsia and Live Births

Details

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.

Keywords

Pregnancy Related, Pre-Eclampsia, frozen embryo transfer, infertility, in vitro fertilization, Eclampsia, Modified natural cycle, Programmed cycle

Eligibility

You can join if…

Open to females ages 18-41

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 per the site director), within one year of study enrollment and repeated at the discretion of the investigator. Use of thyroid medication is permitted.

You CAN'T join if...

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)
  • Mullerian uterine anomaly, if not correctable
  • Physician recommendation to perform the embryo transfer outside of the timing specified by the protocol
  • Contraindication to any medication which must be used in preparation for the frozen embryo transfer (i.e., estradiol, progesterone, hCG)

Locations

  • UCSF accepting new patients
    San Francisco California 94158 United States
  • Stanford University accepting new patients
    Sunnyvale California 94087 United States

Lead Scientist at UCSF

  • Marcelle Cedars, MD
    Professor, Ob/Gyn, Reproductive Sciences, School of Medicine. Authored (or co-authored) 289 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
JHSPH Center for Clinical Trials
ID
NCT04551807
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 788 study participants
Last Updated