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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeUp to 40
SponsorInternational Peace Maternity and Child Health Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Letrozole

    Drug

    Different endothelial preparations according to groups, see arm descriptions for details

Treatment groups

858 Participants
are divided into 3 treatment groups
Group A: Letrozole-induced endometrial preparation protocolExperimental treatment 1 intervention
Group B: Natural cycles endometrial preparation protocolNo intervention 0 interventions
Group C: Hormone replacement cycles endometrial preparation protocolNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Live birth

The number of deliveries resulting in at least one live birth

Time frame
40-42 weeks'estimated gestational age

Secondary outcomes

1

Clinical pregnancy

Clinical pregnancies diagnosed by ultrasonographic visualisation of gestational sacs, the number of clinical pregnancies expressed per 100 embryo transfer cycles

Time frame
5-7 weeks' estimated gestational age
2

embryo implantation

Serum Human Chorionic Gonadotropin levels \>10 IU/L, the number of gestational sacs observed divided by the number of embryos transferred

Time frame
14 day after embryo transfer

Other outcomes

Sponsors and contacts

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