Actively Recruiting
Clinical Outcomes of Letrozole-induced Endometrial Preparation Versus Natural and Hormone Replacement Protocols in Frozen-thawed Embryo Transfer: A Randomized Controlled Study
Led by International Peace Maternity and Child Health Hospital · Updated on 2023-08-23
858
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare pregnancy and perinatal outcomes for women undergoing in vitro fertilization (IVF) treatments using different endometrial preparation protocols for frozen-thawed embryo transfer (FET). It focuses on patients undergoing IVF or intracytoplasmic sperm injection (ICSI) and evaluates whether letrozole-induced endometrial preparation improves live birth and clinical pregnancy rates. The study also explores effects on spontaneous abortion, cycle cancellations, preparation duration, and clinic visits. Participants are randomly assigned based on menstrual cycle regularity to one of three groups: letrozole-induced ovulation stimulation, natural cycle, or hormone replacement cycle. The letrozole group takes letrozole for five days starting day 3 of the cycle, followed by hormone injections and ultrasound monitoring until ovulation and embryo transfer. The natural cycle group monitors follicular growth with ultrasound before embryo transfer, and hormone replacement involves estradiol and progesterone administration before transfer. Embryos are transferred either 2-3 days after ovulation or 5 days later if blastocysts. Supportive medications continue for 14 days post-transfer. Women under 40 undergoing IVF with certain embryo availability are included. The study involves ultrasound and hormone tests to monitor follicle and endometrial development. Researchers measure outcomes such as live birth at 40-42 weeks gestation, clinical pregnancy at 5-7 weeks, and embryo implantation 14 days post-transfer. Safety and pregnancy progress are followed through the treatment and post-transfer periods. The study is conducted in a single center and participants undergo only one transfer cycle during the trial.
CONDITIONS
Brief Title
The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women under 40 years of age undergoing IVF or ICSI
- Have undergone 3 or fewer superovulation cycles
- Have 2 or more cleavage embryos or at least 1 blastocyst cryopreserved
- Have had 2 or fewer previous embryo transfer cycles
- Only one transfer cycle with 1-2 embryos per subject enrolled
You will not qualify if you...
- Chromosomal abnormalities in either spouse
- Hydrosalpinx, severe endometriosis, adenomyosis, or uterine/uterine cavity organic diseases such as malformations, polyps, or adhesions
- Underwent pre-implantation genetic diagnosis (PGT)
- Underwent ICSI using surgically obtained epididymal or testicular spermatozoa
- Body mass index (BMI) over 30 kg/m2
- History of recurrent spontaneous abortions
- History of sequential embryo transfer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 to 4 weeks depending on menstrual cycle and protocol
Participants undergo endometrial preparation using one of three protocols: letrozole-induced, natural cycle, or hormone replacement cycle, followed by frozen-thawed embryo transfer and luteal support.
Multiple visits for ultrasound monitoring and medication administration until embryo transfer and for 14 days post-transfer
Trial Site Locations
Total: 1 location
1
Yu Xiao
Shanghai, China
Actively Recruiting
Research Team
C
Chengliang Zhou, Dr.
X
Xiaojun Chen, Dr.
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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