Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF

PHASE3CompletedINTERVENTIONAL
Enrollment

1,100

Participants

Timeline

Start Date

November 25, 2013

Primary Completion Date

September 10, 2015

Study Completion Date

November 14, 2016

Conditions
Infertility
Interventions
DRUG

AFOLIA

225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached

DRUG

Gonal-f® RFF

225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached

Trial Locations (22)

19001

Abington Reproductive Medicine, Abington

19010

Main Line Fertility Center, Bryn Mawr

19087

Shady Grove Fertility RSC, Chesterbrook, PA, Chesterbrook

19104

University of Penn, Philadelphia

19713

Reproductive Associates of Delaware, Newark

20850

Shady Grove Fertility RSC, Rockville

23507

Jones Institute for Reproductive Medicine, Norfolk

30342

Georgia Reproductive Specialists, Atlanta

33759

FL Fertility Institution, Tampa

38120

Fertility Associates of Memphis, Memphis

45209

Institute for Reproductive Health, Cincinnati

60169

In Via Fertility Specialists, Hoffman Estate

60610

Fertility Centers of Illinois, Chicago

75022

Center for Assisted Reproduction, Bedford

77054

Fertility Specialists of Houston, Houston

77063

Houston Fertility Institute, Houston

77598

Center of Reproducitve Medicine, Webster

78731

Texas Fertility Center, Austin

85284

Physicians Research Group, Tempe

89519

Nevada Center for Reproductive Medicine, Reno

91436

HRC Fertility, Encino

08053

Cooper Institute of Reproductive Hormonal Disorders, P.C., Marlton

Sponsors
All Listed Sponsors
lead

Fertility Biotech AG

INDUSTRY