Trial intelligence / Profile preview

RISE: Rekovelle for Intrauterine Successful Experience

NCT07153367Phase 2

Key facts

Status: Recruiting
Start: Dec 2025
Primary completion: Dec 2027
Countries: 1
Sponsor: Centre Hospitalier Intercommunal de Créteil
Modality: Recombinant Proteins and Enzymes

Drugs: follitropin delta
Conditions: infertility

Overview

Phase 2, open-label, single-arm trial of follitropin delta in infertility, sponsored by Centre Hospitalier Intercommunal de Créteil. Primary endpoint: Percentage of cycles with two mature follicles at the stage of triggering ovulation up to 9 months. Started Dec 2025; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Rekovelle Arm
Fixed dose of 3.66 mcg of Rekovelle on day 4 of the natural cycle

Who it enrols

Normo-ovulatory women aged 18-38 with a BMI of 18-29 kg/m2, regular menstrual cycles, and normal uterine cavity undergoing their first IUI treatment.

Endpoints

Primary

Percentage of cycles with two mature follicles at the stage of triggering ovulationup to 9 months

Secondary

Number of follicles >=14 mm on the day of triggerUp to Day 15 of the cycle
Number of follicles between 10 et 13 mm on the day of triggerUp to Day 15 of the cycle
E2 level on the day of triggerUp to Day 15 of the cycle
PG level on the day of triggerUp to Day 15 of the cycle
LH level on the day of triggerUp to Day 15 of the cycle
Cycle cancellation rateup to 9 months
Pregnancy loss rateup to 9 months
Rate of Biochemical pregnancy (βhCG test) by initiated cycleFrom enrollment to 2 weeks after IUI

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