Actively Recruiting

Phase Not Applicable
Age: 0 - 40Years
FEMALE
NCT06006091

The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)

Led by International Peace Maternity and Child Health Hospital · Updated on 2023-08-23

858

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this single center, non-blinded, randomized controlled clinical trial to comparison of pregnancy outcomes and perinatal outcomes in patients undergoing IVF treatment (including ICSI) with FET with letrozole-induce endothelial preparation protocol versus natural cycles, hormone replacement protocol. The main questions it aims to answer are: * To investigate whether letrozole-induce endothelial preparation is effective in improving the live birth rate and clinical pregnancy rate. * To explore its possible impact on clinically important indicators such as spontaneous abortion rate, implantation cycle cancellation rate, days of endothelial preparation, and number of visits to the clinic. The study subjects were randomized into groups starting at D1-D3 of the menstrual cycle. The study subjects were stratified according to whether their menstrual cycles were regular or not, and were divided into the following endothelial preparation regimens according to the pre-prepared stratified zoned randomized group numbers: (1) regular menstrual cycles (25-35 d): letrozole ovulation-promoting cycles, natural cycles, and hormone-replacement cycles; and (2) irregular menstrual cycles (\<25 d or \>35 d): letrozole ovulation-promoting cycles, hormone-replacement cycle.

CONDITIONS

Official Title

The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)

Who Can Participate

Age: 0 - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women younger than 40 years undergoing IVF or ICSI at the reproductive center
  • 3 or fewer superovulation cycles completed
  • At least 2 cleavage embryos or 1 blastocyst cryopreserved
  • 2 or fewer previous embryo transfer cycles
  • Only one transfer cycle with 1-2 embryos per participant enrolled
Not Eligible

You will not qualify if you...

  • Chromosomal abnormalities in either partner
  • Hydrosalpinx, severe endometriosis, adenomyosis, or uterine abnormalities such as malformations, polyps, or adhesions
  • Previous pre-implantation genetic diagnosis (PGT)
  • ICSI using sperm obtained surgically from epididymal or testicular sources
  • Body mass index (BMI) over 30 kg/m2
  • History of recurrent spontaneous abortions
  • Participants with sequential embryo transfers

AI-Screening

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Trial Site Locations

Total: 1 location

1

Yu Xiao

Shanghai, China

Actively Recruiting

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Research Team

C

Chengliang Zhou, Dr.

CONTACT

X

Xiaojun Chen, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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