Safety and efficacy study comparing a new hMG formulation (hMG-IBSA) to a reference product (Menopur®) in patients undergoing ovarian stimulation for in vitro fertilisation (IVF).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021021-13-GB

Enrollment

272

Registered

2010-07-30

Start date

2010-11-25

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Patients, with basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l), undergoing controlled ovarian stimulation for in vitro fertilisation. MedDRA version: 12.1 Level: LLT Classification code 10056204 Term: In vitro fertilisation

Interventions

Product Name: hMG-IBSA Product Code: ? Pharmaceutical Form: Powder and solvent for solution for injection CAS Number: 9002-68-0 Other descriptive name: FOLLICLE-STIMULATING HORMONE Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women undergoing ovarian stimulation for IVF with the following characteristics: • Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule; • =18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • age 10 mm; • hydrosalpinx that have not been surgically removed or ligated; • stage 3 or 4 endometriosis; • oocyte donation; • implantation of previously frozen embryos; • patients affected by pathologies associated with any contraindication of being pregnant; • hypersensitivity to the study medication; • abnormal bleeding of undetermined origin; • uncontrolled thyroid or adrenal dysfunction; • neoplasias; • severe impairment of renal and/or hepatic function; • use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents).

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of the study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations (hMG-IBSA, IBSA Institut Biochimique SA vs Menopur®, Ferring Pharmaceuticals) when administered to patients undergoing controlled ovarian stimulation for IVF;Secondary Objective: ;Primary end point(s): Total number of oocytes retrieved	—

Countries

Denmark, Hungary, United Kingdom

Outcome results

None listed

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