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

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2013-003817-16-GB
• Date of registration: 23/12/2013
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA
• Public title: A study to compare Pergoveris and GONAL-f in women who have responded poorly to previous infertiliy treatment cycles
• Scientific title: 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
• Date of first enrolment: 30/01/2014
• Target sample size: 946
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003817-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Communication Centre Merck KGaA
• Affiliation: Merck KGaA

• Name: Communication Centre Merck KGaA
• Affiliation: Merck KGaA

Key inclusion & exclusion 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 (< 41 years), no for any risk factor
? ESHRE Criteria = A previous POR (= 3 oocytes with a conventional stimulation protocol)
INCLUSION for this study: Yes
? ESHRE Criteria = An abnormal ovarian reserve test (ORT) (ie, anti-mullerian hormone [AMH] < 0.5 - 1.1 ng mL)
INCLUSION for this study: Yes for AMH only (= lower limit of assay detection – 1.3 ng/mL, inclusive)

Additional inclusion criteria are:
2.Female subjects, 18 to < 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including ICSI
3.Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
4.Absence of any medical condition in which pregnancy is contraindicated
5.Body mass index 18 to 30 kg/m2, inclusive
6.Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial.
7.Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening
8.Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrolment

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 946
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

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

Intervention(s)

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: 56832-30-5
Other descriptive name: FOLLITROPIN ALFA
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 150-
INN or Proposed INN: Lutropin alfa
CAS Number: 152923-57-4
Other descriptive name: LUTROPIN ALFA
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 75-

Trade Name: GONAL-f 450 IU/0.75 ml (33 micrograms/0.75 ml) powder and solvent for solution for injection
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Follitropin alfa
CAS Number: 56832-30-5
Other descriptive name: FOLLITROPIN ALFA
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 600-

Primary Outcome(s)

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.

Main Objective: The primary objective of the trial is to demonstrate superiority of Pergoveris® versus GONAL-f® in poor ovarian response (POR) patients.

Primary end point(s): Total number of retrieved oocytes.

Timepoint(s) of evaluation of this end point: On/before day 113 (Visit 12)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Visits 14 to 17 as described above

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).

Secondary ID(s)

EMR200061-005

2013-003817-16-CZ

Source(s) of Monetary Support

Merck KGaA, Darmstadt