Effect of recombinant FSH dosing following corifollitropin alfa in patients undergoing IVF/ICSI in a GnRH antagonist protocol: a randomized controlled dose-finding study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002000-13-BE

Enrollment

261

Registered

2018-11-09

Start date

2019-01-09

Completion date

Unknown

Last updated

2024-10-07

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

Conditions

Subfertility in need of IVF and IVF-ICSI treatment MedDRA version: 20.0 Level: LLT Classification code 10042392 Term: Subfertility (female) System Organ Class: 100000004872

Interventions

Trade Name: Elonva Product Name: Elonva Product Code: EU/1/09/609/002 Pharmaceutical Form: Solution for injection INN or Proposed INN: CORIFOLLITROPIN ALFA CAS Number: 195962-23-3 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Female age: > 18 to 36 years old, body weight should be > 50 kg • Regular normo-ovulatory menstrual cycles (26–35 days) • Basal FSH 7 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Polycystic ovarian syndrome (PCOS) according to the Rotterdam classification (2004) • Oocyte donors • Poor responder patients (development of <4 follicles in previous IVF/ICSI or cancelled cycles) • Endometriosis = grade 3 • Contraindications to the use of gonadotropins • Abnormal vaginal bleeding of unknown cause • History of ovarian hyperstimulation syndrome (OHSS) or a previous ovarian stimulation cycle with more than 30 follicles of 11 mm or higher (as recommended by the Elonva® Summary of Product Characteris-tics) • A history of recurrent miscarriage (three or more consecutive miscarriages)

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the mean serum progesterone level (ng/mL) on day of hCG between the study groups.;Secondary Objective: Assess the number of retrieved oocytes, number of mature oocytes, number of top quality embryos on Day 3, clinical pregnancy rate (number of viable pregnancies at 6 weeks of gestation per ITT and PP), ongo-ing pregnancy rate (number of viable pregnancies at 12 weeks of gestation per ITT and PP), miscarriage rate and percentage of patients with a P value above 1.5 ng/mL on the day of hCG.;Primary end point(s): -Mean serum P level on trigger day;Timepoint(s) of evaluation of this end point: at the end of inclusion	—

Measure

Time frame

Main Objective: Compare the mean serum progesterone level (ng/mL) on day of hCG between the study groups.;Secondary Objective: Assess the number of retrieved oocytes, number of mature oocytes, number of top quality embryos on Day 3, clinical pregnancy rate (number of viable pregnancies at 6 weeks of gestation per ITT and PP), ongo-ing pregnancy rate (number of viable pregnancies at 12 weeks of gestation per ITT and PP), miscarriage rate and percentage of patients with a P value above 1.5 ng/mL on the day of hCG.;Primary end point(s): -Mean serum P level on trigger day;Timepoint(s) of evaluation of this end point: at the end of inclusion

—

Secondary

Measure	Time frame
Secondary end point(s): - Number of COCs retrieved - Number of patients who underwent FA - Clinical pregnancy rate - Ongoing pregnancy rate - Miscarriage rate ;Timepoint(s) of evaluation of this end point: at the end of inclusion	—

Countries

Belgium

Contacts

Public ContactChristophe Blockeel

CRG UZ Brussel

+32024776648

Outcome results

None listed

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