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

Merck KGaA, Darmstadt, Germany1 site in 1 country939 target enrollmentJanuary 31, 2014

ConditionsInfertility

InterventionsPergoveris®Recombinant human chorionic gonadotrophin (r-hCG)GONAL-f®

DrugsPergoveris®GONAL-f®Recombinant human chorionic gonadotrophin (r-hCG)

Overview

Phase: Phase 3
Intervention: Pergoveris®
Conditions: Infertility
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 939
Locations: 1
Primary Endpoint: Number of Oocytes Retrieved
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 31, 2014

End Date

August 31, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Responsible Party

Sponsor

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

Arms & Interventions

Pergoveris®

Intervention: Pergoveris®

Pergoveris®

Intervention: Recombinant human chorionic gonadotrophin (r-hCG)

GONAL-f®

Intervention: GONAL-f®

GONAL-f®

Intervention: Recombinant human chorionic gonadotrophin (r-hCG)

Outcomes

Primary Outcomes

Number of Oocytes Retrieved

Time Frame: At approximately 34 to 38 hours after r-hCG administration (Day 113)

Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.

Secondary Outcomes

Ongoing Pregnancy Rate(70 days after embryo transfer (Day 185))
Live Birth Rate(Approximately 180 days following ongoing pregnancy determination (Day 365))
Embryo Implantation Rate(35-42 days post r-hCG administration (Day 154))
Clinical Pregnancy Rate(35-42 days post r-hCG administration (Day 154))
Biochemical Pregnancy Rate(15 to 20 days post r-hCG administration (Day 132))