Progesterone-modified Natural Cycle for FET

NCT06644794 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2026-04-29

No results posted yet for this study

Summary

Hormone replacement therapy (HRT) cycles, despite the ease of synchronizing embryo thawing and embryo transfer timing, increase the risk of pregnancies and obstetric complications compared to natural cycles (NC). By ensuring the presence of the corpus luteum while reducing the number of monitoring sessions, the progesterone modified natural cycle (P4mNC) offers more convenience for the patient than the normal NC. This study is designed to compare the effects of P4mNC and HRT cycles on FET outcomes.

Conditions

  • Infertility, Female

Interventions

DRUG

Progesterone-modified natural cycle preparation for frozen embryo transfer

A novel endometrial preparation protocol that optimizes the natural cycle, whereby as long as the thickness of the endometrium is suitable for embryo transfer, vaginal progesterone can be used to transform the endometrium before ovulation and subsequently FET.

DRUG

Hormone replacement therapy cycle preparation for frozen embryo transfer

A traditional endometrial preparation protocol is used for FET, which involves using fixed or flexible exogenous estradiol for artificial cycles. This protocol typically involves starting exogenous estradiol on day 3 or 4 of the cycle, continuing for 7-10 days, and then discontinuing. Upon determining that the endometrial thickness meets the standard, progesterone conversion of the endometrium can be performed.

Sponsors & Collaborators

  • Shandong University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Zhen-Gao Sun, MD · Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-05
Primary Completion
2027-09-10
Completion
2028-12-01

Countries

  • China

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 NCT06644794 on ClinicalTrials.gov