MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population

Inclusion Criteria:

- Females aged 21 to 35 years with regular ovulatory menstrual cycles of 21 to 45 days,
with a Body Mass Index (BMI) between 18 and 30 kg/m2 who desire pregnancy.

- Subjects must be high responders, defined as subjects who have a serum anti-Müllerian
hormone (AMH) ≥5 ng/mL at screening.

- Documented history of infertility (e.g., unable to conceive for at least 12 months or
for at least 6 months if receiving donor sperm) with a Day 2 or Day 3 serum FSH level
between 1 and 12 IU/L (inclusive), the results of which should be obtained within 6
months prior to randomization.

Exclusion Criteria:

- Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).

- History of recurrent miscarriage not followed by a live birth (recurrent is defined as
two (2) or more consecutive miscarriages).

- Previous in vitro fertilization (IVF) or assisted reproductive technology (ART)
failure due to a poor response to gonadotropins. Poor response is defined as
development of ≤2 mature follicles or history of 2 previous failed cycle cancellations
prior to oocytes retrieval due to poor response.