Trial intelligence / Profile preview

Natural vs Artificial Cycle in Frozen Embryo Transfer

NCT03642665Phase 4

Key facts

Status: Completed
Start: Sep 2018
Primary completion: Nov 2024
Countries: 1
Sponsor: UZ Leuven
Modality: Small Molecules

Drugs: estradiol valerateprogesterone
Conditions: infertility

Overview

Phase 4, randomised, open-label trial of estradiol valerate and progesterone in infertility (2 arms), sponsored by UZ Leuven. Primary endpoint: Clinical pregnancy rate with fetal heart beat at 9 weeks. Started Sep 2018; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Natural cycle
No medication, monitoring of natural cycle.
Artificial cycle
Estradiol Valerate 6-8mg/day + Micronized Progesterone 600mg/day.

Who it enrols

Women aged 18-45 undergoing FET after 1-3 fresh IVF/ICSI cycles with a natural ovulatory cycle and normal uterine cavity. Excludes BMI >= 35 and contraindications to estrogen/progesterone.

Endpoints

Primary

Clinical pregnancy rate with fetal heart beat9 weeks

Secondary

Biochemical pregnancy rate9 weeks
Miscarriage rate12 weeks
Ectopic pregnancy rate9 weeks
Live birth rate41 weeks
Multiple pregnancy rate9 weeks
Adverse events12 weeks
Cycle cancellation rate4 weeks
Endometrial thickness3 weeks

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