Prospective randomized trial comparing corifollitropin alfa (CF-alfa) late start (day 4) vs. CF-alfa standard start (day2) in poor, normal and potential high-responders undergoing IVF/ICSI

Prospective randomized trial comparing corifollitropin alfa (CF-alfa) late start (day 4) vs. CF-alfa standard start (day2) in poor, normal and potential high-responders undergoing IVF/ICSI - ELONVA LATE START

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005145-23-IT

Enrollment

110

Registered

2021-09-30

Start date

2017-08-29

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with low reproductive capacity MedDRA version: 20.0 Level: LLT Classification code 10002658 Term: Anovulation System Organ Class: 100000004860 MedDRA version: 20.1 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 100000004872 MedDRA version: 20.0 Level: LLT Classification code 10071102 Term: Controlled ovarian hyperstimulation System Organ Class: 100000004865

Interventions

Trade Name: ELONVA - 150 MCG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) - 0.5 ML 1 SIRINGA PRERIEMPITA + 1 AGO Product Name: Elonva Pharmaceutical Form: Solution for injec

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18-43 years Tubal infertility or male infertility referred for IVF Willingness to undergo randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: absence of Polycystic ovaric syndrome hormonal therapy in the two months preceeding IVF Previous ovarian hyperstimulation syndrome Previous superovulation controlled with excessive response a basalantral follicle count >20 even benign tumors of the ovary, breast, uterus, pituitary gland or hypothalamus

Design outcomes

Primary

Measure	Time frame
Main Objective: compare the number of retrieved oocytes in the late start CF-alfa vs. early start CF-alfa in patients undergoing IVF;Secondary Objective: Compare the two protocols with regard to the oocyte morphology (assessed by polarized light microscopy) the rate of clinical pregnancy to six weeks, the incidence of side effects and the degree of satisfaction of the patient;Primary end point(s): Number of retrieved oocytes at US guided puncture;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: compare the number of retrieved oocytes in the late start CF-alfa vs. early start CF-alfa in patients undergoing IVF;Secondary Objective: Compare the two protocols with regard to the oocyte morphology (assessed by polarized light microscopy) the rate of clinical pregnancy to six weeks, the incidence of side effects and the degree of satisfaction of the patient;Primary end point(s): Number of retrieved oocytes at US guided puncture;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): Pregnancy rate with either applied protocol; Safety and undesired effects of applied protocols;Timepoint(s) of evaluation of this end point: 12 months; 12 months	—

Countries

Italy

Contacts

Public ContactDirezione SC Ginecologia e Ostetric

Università degli Studi di Torino

chiara.benedetto@unito.it0113135770

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026