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Natural Versus Programmed Frozen Embryo Transfer (NatPro)

NCT04551807 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 788

Last updated 2025-05-16

No results posted yet for this study

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).

Conditions

  • Pregnancy Related
  • Pre-Eclampsia

Interventions

PROCEDURE

Modified natural cycle

This treatment protocol is defined as a modified natural cycle as the participant will be instructed to (1) administer human chorionic gonadotropin (hCG) to assist with timing of the embryo transfer and (2) supplement the luteal phase with a low dose of progesterone.

PROCEDURE

Programmed cycle

This protocol is designated as programmed because the endometrial development occurs only in association with administration of estradiol and progesterone. No ovulation occurs due to suppression of follicle development by the estradiol and the timing of the transfer is based on the number of days elapsed following initiation of exogenous progesterone.

Sponsors & Collaborators

  • JHSPH Center for Clinical Trials

    lead OTHER

Principal Investigators

  • Valerie Baker, MD · Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine

  • James Segars, MD · Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2026-02-01
Completion
2026-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04551807 on ClinicalTrials.gov