The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Letrozole.
- Who it may be relevant to
- Registry conditions: Letrozole, Infertility, Female. Basic parameters: up to 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Outcomes of Letrozole-induced Endometrial Preparation Regimens Versus Conventional Endometrial Preparation Regimens Including Natural Cycle, Hormone Replacement Regimens in FET, a Randomized Controlled Study
Overview
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.
Interventions
- Drug Letrozole
Different endothelial preparations according to groups, see arm descriptions for details
Primary outcome measures
- Live birth [Time frame: 40-42 weeks'estimated gestational age]
Secondary outcome measures (2)
- Clinical pregnancy [Time frame: 5-7 weeks' estimated gestational age]
- embryo implantation [Time frame: 14 day after embryo transfer]
Eligibility criteria
Inclusion criteria
Women <40 years of age undergoing IVF or ICSI at our reproductive center with a total of ≤3 superovulation cycles , and with ≥2 cleavage embryos or ≥1 blastocyst were cryopreserved. Previous cycles of embryo transfer ≤ 2 and only one transfer cycle with 1-2 embryos per study subject was enrolled.
Exclusion criteria
- Patients with chromosomal abnormalities in either spouse, hydrosalpinx, severe endometriosis, adenomyosis, and uterine and uterine cavity organic diseases such as uterine malformations, endometrial polyps, and uterine adhesions;
- patients who underwent pre-implantation genetic diagnosis (PGT);
- patients who underwent ICSI using surgically obtained epididymal or testicular spermatozoa;
- patients with a Body mass index (BMI, = weight/height2 ) > 30 kg/m2;
- patients with recurrent spontaneous abortions;
- patients with sequential embryo transfer.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Yu Xiao — Shanghai
Identifiers
NCT: NCT06006091 · InternationalPMCHH-1