A study to compare Pergoveris and GONAL-f in women who have responded poorly to previous infertiliy treatment cycles

A phase III, randomized, controlled, single-blind, multicentre, parallel arm trial to assess the efficacy and safety of Pergoveris® (follitropin alfa and lutropin alfa) and GONAL-f® (follitropin alfa) for multifollicular development as part of an assisted reproductive technology treatment cycle in poor ovarian responders, as defined by the European Society of Human Reproduction and Embryology criteria - ESPART Evaluating the Efficacy and the Safety of Pergoveris®in ART

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003817-16-CZ

Enrollment

946

Registered

2013-12-13

Start date

2014-02-05

Completion date

Unknown

Last updated

2015-09-14

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

Conditions

Poor Ovarian Response i.e. a failure to respond adequately to standard ART (assisted reproductive technologies) protocols and to recruit adequate follicles MedDRA version: 17.0 Level: LLT Classification code 10033140 Term: Ovarian disorder NOS System Organ Class: 100000004872

Interventions

Trade Name: Pergoveris 150 IU-75 IU Powder and solvent for solution for injection Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Follitropin alfa CAS Number: 5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The current trial will enroll poor ovarian responders as aligned with the 2011 Consensus Meeting of the ESHRE 1. Subject must be a poor responder at least 2 of the following 3 features must be present: ? ESHRE criteria = Advanced maternal age (= 40 years) or any risk factor for POR - INCLUSION for this study: Yes (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.Primary ovarian failure 2.Preimplantation genetic screening or diagnosis 3.Two episodes of POR after maximal stimulation 4.History or presence of tumors of the hypothalamus or pituitary gland 5.History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst > 25 mm on the day of randomization 6.Presence of endometriosis Grade III – IV, confirmed or suspected 7.Presence of uni- or bilateral hydrosalpinx 8.Abnormal gynecological bleeding of undetermined origin 9.Malformations of sexual organs incompatible with pregnancy 10.Contraindication to being pregnant and/or carrying a pregnancy to term 11.Currently pregnant

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the trial is to demonstrate superiority of Pergoveris® versus GONAL-f® in poor ovarian response (POR) patients.;Secondary Objective: Key secondary objectives will include assessment of other clinical variables that reflect the efficacy of ovarian stimulation and safety assessment of combination treatment with recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing r-hLH (Pergoveris®) as compared to r-hFSH (GONAL-f®)-only treatment.;Primary end point(s): Total number of retrieved oocytes. ;Timepoint(s) of evaluation of this end point: On/before day 113 (Visit 12)	—

Measure

Time frame

Main Objective: The primary objective of the trial is to demonstrate superiority of Pergoveris® versus GONAL-f® in poor ovarian response (POR) patients.;Secondary Objective: Key secondary objectives will include assessment of other clinical variables that reflect the efficacy of ovarian stimulation and safety assessment of combination treatment with recombinant human follicle-stimulating hormone (r-hFSH) and recombinant human luteinizing r-hLH (Pergoveris®) as compared to r-hFSH (GONAL-f®)-only treatment.;Primary end point(s): Total number of retrieved oocytes. ;Timepoint(s) of evaluation of this end point: On/before day 113 (Visit 12)

—

Secondary

Measure	Time frame
Secondary end point(s): • Ongoing pregnancy rate (assessed on/before day 185 -Visit 16). • Live birth rate (assessed on/before day 365 - Visit 17). • Embryo implantation rate (determined on/before day 154 - Visit 15). • Clinical pregnancy rate (determined on/before day 154 - Visit 15). • Biochemical pregnancy rate (determined on/before day 132 - Visit 14). ;Timepoint(s) of evaluation of this end point: Visits 14 to 17 as described above	—

Measure

Time frame

Secondary end point(s): • Ongoing pregnancy rate (assessed on/before day 185 -Visit 16). • Live birth rate (assessed on/before day 365 - Visit 17). • Embryo implantation rate (determined on/before day 154 - Visit 15). • Clinical pregnancy rate (determined on/before day 154 - Visit 15). • Biochemical pregnancy rate (determined on/before day 132 - Visit 14). ;Timepoint(s) of evaluation of this end point: Visits 14 to 17 as described above

—

Countries

Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Netherlands, Poland, Russian Federation, Spain, Sweden, Turkey, United Kingdom

Contacts

Public ContactCommunication Centre Merck KGaA

Merck KGaA

service@merckgroup.com496151725200

Outcome results

None listed

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