Summary

Eligibility
for females ages 18-41 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
completion around

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

Locations

  • University of California San Francisco
    San Francisco California 94158 United States
  • Stanford University
    Sunnyvale California 94087 United States

Details

Status
in progress, not 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
About 788 people participating
Last Updated