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NCT Number: NCT06006091

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

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.

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Key information

Age range

Up to 40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yu Xiao

Shanghai, China

Location status: Recruiting

Location contact

Yu Xiao, Dr.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

letrozole

Drug

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

Primary outcomes

  1. Live birth

    Time frame: 40-42 weeks'estimated gestational age

    The number of deliveries resulting in at least one live birth

Secondary outcomes

  1. Clinical pregnancy

    Time frame: 5-7 weeks' estimated gestational age

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

  2. embryo implantation

    Time frame: 14 day after embryo transfer

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chengliang Zhou, Dr.

CONTACT

[email protected]

08613758240793

Xiaojun Chen, Dr.

CONTACT

[email protected]

19921917097

Sponsors and collaborators

Lead sponsor

International Peace Maternity and Child Health Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 23, 2023
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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