Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 3

Conditions

Infertility

Treatments

Drug: GONAL-f®

Drug: Pergoveris®

Drug: Recombinant human chorionic gonadotrophin (r-hCG)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02047227

EMR200061-005

2013-003817-16 (EudraCT Number)

Details and patient eligibility

About

This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone [r-hFSH]/recombinant human luteinising hormone [r-hLH]) and GONAL-f® for multifollicular development as part of an assisted reproductive technology (ART) treatment cycle in poor ovarian responders, as aligned with the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) criteria.

Enrollment

939 patients

Sex

Female

Ages

18 to 41 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Poor ovarian responders according to specific criteria that are aligned with poor ovarian response (POR) criteria defined by the 2011 Consensus Meeting of the European Society of Human Reproduction and Embryology (ESHRE) as mentioned in the protocol
Female subjects, less than (<) 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
Absence of any medical condition in which pregnancy is contraindicated
Body mass index 18 to 30 kilogram per square meter (kg/m^2), inclusive
Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection will be allowed during this trial
Minimum of 1 month without treatment with either clomiphene citrate or gonadotrophins prior to screening
Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment

Exclusion criteria

Two episodes of POR after maximal stimulation
History or presence of tumors of the hypothalamus or pituitary gland
History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 mm on the day of randomization
Presence of endometriosis Grade III - IV, confirmed or suspected
Presence of uni- or bilateral hydrosalpinx
Abnormal gynecological bleeding of undetermined origin
Contraindication to being pregnant and/or carrying a pregnancy to term
History or presence of ovarian, uterine or mammary cancer
Use of testicular or epididymal sperm
Other protocol defined exclusion criteria could apply