FET-LET-2x2: Clinical Pregnancy Rates After Frozen Embryo Transfer in Natural and Modified Natural Cycles

N/ANot Yet RecruitingNCT07425990

University of Novi Sad120 enrolled

Overview

The goal of this clinical trial is to learn whether different natural approaches to preparing the uterus for frozen embryo transfer (FET) can improve pregnancy success in women undergoing in vitro fertilization (IVF) treatment. The main questions it aims to answer are: 1. Is a completely natural menstrual cycle more successful than a natural cycle in which ovulation is triggered with medication when preparing for frozen embryo transfer? 2. Does taking a medication called letrozole at the beginning of the cycle improve pregnancy success compared to not taking it? Researchers will compare four different approaches to see which one results in the highest chance of achieving a clinical pregnancy, confirmed by ultrasound. Participants will: * Be randomly assigned to one of four groups * Undergo monitoring with ultrasound and blood hormone tests during their menstrual cycle * In some groups, take letrozole tablets for a few days early in the cycle * In some groups, receive a hormone injection to help control the timing of ovulation * Undergo frozen embryo transfer at the appropriate time * Receive standard hormonal support after embryo transfer * Researchers will compare four different approaches to see which one results in the highest chance of achieving a clinical pregnancy, confirmed by ultrasound.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Infertility Female Frozen Embryo Transfer (FET)

Interventions

Letrozole (Aromatase Inhibitors)DRUG

Letrozole 2.5 mg administered orally twice daily from cycle days 3-7 during the early follicular phase.

Choriogonadotropin alpha (r-hCG)DRUG

Recombinant human chorionic gonadotropin (hCG) 250 mcg administered subcutaneously to trigger ovulation when follicular and endometrial criteria are met.

ProgesteroneDRUG

Luteal phase support with either vaginal progesterone 200 mg twice daily or subcutaneous progesterone 25 mg once daily, initiated after ovulation (or 2 days after hCG trigger) and continued until 12 weeks of gestation if pregnancy occurs.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women aged 18 to 40 years * Regular menstrual cycles (26-35 days) * Scheduled for frozen embryo transfer (FET) in a natural menstrual cycle * Normal gynecological ultrasound findings without clinically significant uterine abnormalities * Ability to provide written informed consent Exclusion Criteria: * Use of preimplantation genetic testing (PGT) for the transferred embryo * Use of donor oocytes * Inadequate embryo survival after thawing, defined as loss of viability in more than 50% of blastomeres * Irregular menstrual cycles * Presence of clinically significant uterine abnormalities detected by ultrasound * Inability or unwillingness to provide written informed consent

Outcomes

Primary Outcomes

Clinical Pregnancy Rate

Number of pregnancies with an ultrasound-confirmed gestational sac per embryo transfer.

Time frame: Approximately 4-6 weeks after embryo transfer.

Secondary Outcomes

Biochemical Pregnancy Rate

Number of pregnancies with elevated serum beta-human chorionic gonadotropin (β-hCG) levels measured two weeks after embryo transfer, per embryo transfer.

Time frame: Two weeks after embryo transfer.

Implantation Rate

Number of ultrasound-confirmed gestational sacs divided by the number of embryos transferred.

Time frame: Approximately 4-6 weeks after embryo transfer.

Miscarriage Rate

Pregnancy loss before 23 completed weeks of gestation, expressed per embryo transfer.

Time frame: Up to 23 weeks of gestation.