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

Recruitment & 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 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

Study & Design

Arm && Interventions

Group	Intervention	Description
Pergoveris®	Recombinant human chorionic gonadotrophin (r-hCG)	-
GONAL-f®	GONAL-f®	-
GONAL-f®	Recombinant human chorionic gonadotrophin (r-hCG)	-
Pergoveris®	Pergoveris®	-

Primary Outcome Measures

Name	Time	Method
Number of Oocytes Retrieved	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 Outcome Measures

Name	Time	Method
Ongoing Pregnancy Rate	70 days after embryo transfer (Day 185)	Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat).
Live Birth Rate	Approximately 180 days following ongoing pregnancy determination (Day 365)	Live birth rate was defined as the percentage of subjects with at least one live-born neonate.
Embryo Implantation Rate	35-42 days post r-hCG administration (Day 154)	Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.
Clinical Pregnancy Rate	35-42 days post r-hCG administration (Day 154)	Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.
Biochemical Pregnancy Rate	15 to 20 days post r-hCG administration (Day 132)	Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test.

Recruitment & Eligibility