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

Infertility Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047227
• Other study ID #: EMR200061-005
• Secondary ID: 2013-003817-16
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2014
• Last updated: September 9, 2015
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: Ethics CommitteeCzech Republic: State Institute for Drug ControlDenmark: Centre for Public HealthDenmark: National Board of HealthEstonia: Research Ethics CommitteeEstonia: The State Agency of MedicineFinland: Ethics CommitteeFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesHungary: Scientific and Medical Research Council Ethics CommitteeHungary: GYEMSZIItaly: Ethics CommitteeItaly: Ministry of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthLatvia: State Agency of MedicinesLatvia: Institutional Review BoardNetherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación ClínicaSweden: Medical Products AgencySweden: Regional Ethical Review BoardTurkey: Ethics CommitteeTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 939
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

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 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Pergoveris®
Pergoveris® (r-hFSH/r-hLH) will be self-administered daily subcutaneously at a starting dose of 300 International Unit (IU) r-hFSH/150 IU r-hLH from stimulation day 1 until recombinant human chorionic gonadotrophin (r-hCG) administration day (when follicle[s] reach a mean diameter of 17-18 millimeter [mm]). Dose adjustment will be done as per Investigator's discretion based upon individual response of the subject to the treatment.
• GONAL-f®
GONAL-f® (r-hFSH) will be self-administered daily subcutaneously at a starting dose of 300 IU from stimulation day 1 until r-hCG administration day (when follicle[s] reach a mean diameter of 17-18 mm). Dose adjustment will be done as per Investigator's discretion based upon individual response of the subject to the treatment.
• Recombinant human chorionic gonadotrophin (r-hCG)
On r-hCG day, 250 microgram of r-hCG will be administered once subcutaneously.

Locations

Country	Name	City	State
Germany	Please contact the Merck KGaA Communication Center	Darmstadt

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of retrieved oocytes		Up to Day 113	No
Secondary	Ongoing pregnancy rate	Ongoing pregnancy rate is defined as the percentage of subjects with a transvaginal ultrasound confirmation of at least one viable fetus (positive fetal heart beat).	Up to Day 185	No
Secondary	Live birth rate	Live birth rate is defined as the number of deliveries that resulted in at least one live born baby expressed per 100 initiated cycles, aspiration cycles or embryo transfer cycles.	Up to Day 365	No
Secondary	Embryo implantation rate	Embryo implantation rate is defined as the number of gestational sacs observed, divided by the number of embryos transferred.	Up to Day 154	No
Secondary	Clinical pregnancy rate	Clinical pregnancy rate is defined as the number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles or embryo transfer cycles.	Up to Day 154	No
Secondary	Biochemical pregnancy rate	Biochemical pregnancy rate is defined as percentage of subjects with a pregnancy diagnosed only by the detection of human chorionic gonadotrophin (beta-hCG) in serum or urine and that does not develop into a clinical pregnancy.	Up to Day 132	No