Clinical trial NCT02047227: Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: ESPART
Reproductive Techniques, Assisted
Infertility
Pergoveris®
GONAL-f®
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2014-01-28
Enrollment: 939
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Oocytes Retrieved
timeFrame: At approximately 34 to 38 hours after r-hCG administration (Day 113)
Secondary outcomes:
measure: Ongoing Pregnancy Rate
timeFrame: 70 days after embryo transfer (Day 185)
measure: Live Birth Rate
timeFrame: Approximately 180 days following ongoing pregnancy determination (Day 365)
measure: Embryo Implantation Rate
timeFrame: 35-42 days post r-hCG administration (Day 154)
measure: Clinical Pregnancy Rate
timeFrame: 35-42 days post r-hCG administration (Day 154)
measure: Biochemical Pregnancy Rate
timeFrame: 15 to 20 days post r-hCG administration (Day 132)
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Please contact the Merck KGaA Communication Center
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Humaidan P, Chin W, Rogoff D, D'Hooghe T, Longobardi S, Hubbard J, Schertz J; ESPART Study Investigatorsdouble dagger. Efficacy and safety of follitropin alfa/lutropin alfa in ART: a randomized controlled trial in poor ovarian responders. Hum Reprod. 2017 Mar 1;32(3):544-555. doi: 10.1093/humrep/dew360.
citation: Humaidan P, Schertz J, Fischer R. Efficacy and Safety of Pergoveris in Assisted Reproductive Technology--ESPART: rationale and design of a randomised controlled trial in poor ovarian responders undergoing IVF/ICSI treatment. BMJ Open. 2015 Jul 3;5(7):e008297. doi: 10.1136/bmjopen-2015-008297.