Merck Announces Initiation of Phase III Fertility Study with Pergoveris in Poor Ovarian Response Patients

Darmstadt, Germany (ots/PRNewswire) -



- The ESPART* Phase III clinical study focuses on patients that respond
poorly to attempts at ovarian stimulation
- Study aims to recruit 946 patients across 17 European countries

Merck, the global pharmaceutical and chemical company, today
announced the enrollment of the first patient into a new Phase III
study in the area of fertility, marking another step in its efforts
to explore innovative solutions in areas of unmet medical need.

The ESPART* study is designed to assess the efficacy and safety of
Pergoveris(R) (follitropin alfa and lutropin alfa) versus GONAL-f(R)
(follitropin alfa) for multifollicular development as part of an
Assisted Reproductive Technology (ART) treatment cycle in women who
are classified as poor ovarian responders (POR). Generally, in such
patients, a low number of follicles develop during treatment, and, as
a consequence, a small number of oocytes are retrieved through ART.
The study aims to recruit 946 patients across 17 European countries.
Pergoveris is a fixed combination of recombinant human follicle
stimulating hormone (r-hFSH) and recombinant human luteinizing
hormone (r-hLH) delivered via subcutaneous injection.

"The ESPART study is part of our ongoing commitment to working
with fertility specialists to achieve the shared goal of increasing
pregnancy rates and addressing the challenges that patients face in
order to help them overcome the barriers to fertility," said John
Orloff, Head of Clinical Development of Merck Serono, the
biopharmaceutical division of Merck. "As a leader in reproductive
health we hope that it will help us understand how to better address
the challenges faced by women with poor ovarian response."

Merck has committed itself to finding innovative solutions to
develop the next generation of fertility treatments. More than 72.4
million people are affected by infertility worldwide[1] and,
according to the World Health Organization (WHO),[2] 15 percent of
couples of childbearing age seek medical help for infertility.
Infertility is one of the main focus areas and an important growth
driver for Merck's largest division.

"A current trend in society is for women to delay pregnancy until
later in their life and, as a consequence, women may face lower
chances of pregnancy due to the reduced quantity and quality of
oocytes in their ovaries, thus new treatment options are needed in
fertility to maximize the chances of success," said Professor Peter