NCT07425990

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

FET-LET-2x2: A Randomized Open-Label 2×2 Factorial Trial Comparing Clinical Pregnancy Rates After Frozen Embryo Transfer in True and Modified Natural Cycles With and Without Aromatase Inhibitors

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Novi Sad · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Infertility Female
• Frozen Embryo Transfer (FET)

Interventions

Type	Name	Description
DRUG	Letrozole (Aromatase Inhibitors)	Letrozole 2.5 mg administered orally twice daily from cycle days 3-7 during the early follicular phase.
DRUG	Choriogonadotropin alpha (r-hCG)	Recombinant human chorionic gonadotropin (hCG) 250 mcg administered subcutaneously to trigger ovulation when follicular and endometrial criteria are met.
DRUG	Progesterone	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-02-01
• Completion: 2027-03-01
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Serbia