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

Completed · Phase 3

Conditions studied: Infertility

In brief

The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f® RFF.

Key facts

Study ID

NCT01687712

Run by

Fertility Biotech AG

People needed

1100

Starts

2013-11-25

Expected to finish

2016-11-14

Last updated by the study team

2017-12-05

Who can join

Age: 35 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 35 to 42 years of age
• Indication for controlled ovarian stimulation and IVF or intracytoplasmic sperm injection (ICSI)
• Regular menstrual cycles (25-35 days)
• History of a maximum of two fresh cycle treatments in the present series of assisted reproductive technologies (ART) at the day of first screening (thawed cycles are not subject to that criteria)
• Body mass index (BMI) ≥18 and ≤38 kg/m2
• Basal FSH <12 IU/L (cycle day 2-5)
• Antral follicle count (AFC) ≥ 10 to ≤20 follicles with a diameter of <11mm (sum of both ovaries) as measured on ultrasound (US) in the early follicular phase (menstrual cycle day 2-5)
• Documented history of infertility due to any of the following factors: tubal factor, mild endometriosis (American Society for Reproductive Medicine [ASRM] stage 1-2), male factor, unexplained infertility
• Presence of both ovaries by ultrasonography and normal uterine cavity (confirmed by hysterosalpingography, saline infusion sonography or hysteroscopy within 6 months before randomization)
• Male partner with semen analysis that is at least adequate for ICSI within 6 months prior to patient beginning down-regulation (invasive or surgical sperm retrieval, donor and/or cryopreserved sperm may be used)
• Willingness to participate in the study and to comply with the study protocol
• Signed informed consent prior to screening

You may not qualify if…

• Presence of pregnancy
• History of or active polycystic ovary syndrome (PCOS)
• AFC >20 follicles with a diameter of <11 mm (both ovaries combined) as measured on US in the early follicular phase (menstrual cycle day 2-5)
• History of >2 unsuccessful fresh ART retrieval cycles
• Presence of uncontrolled endocrine disorder
• Previous history or presence of severe OHSS
• Intrauterine fibroids ≥5 cm or otherwise clinically relevant pathology that could impair embryo implantation or pregnancy continuation
• History of recurrent spontaneous abortion (3 or more, even when unexplained)
• Presence of severe endometriosis (ASRM stage 3 or stage 4) or hydrosalpinx
• Neoplasia, including tumors of the hypothalamus and pituitary gland
• Abnormal bleeding of undetermined origin
• History of extrauterine pregnancy in the previous 3 months
• Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medications (GnRH agonist, Ovidrel®, and Crinone 8%®)
• History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)
• Any hormonal treatment within 1 month before the start of the FSH treatment, with the exception of levothyroxine)
• Egg donor
• Administration of other investigational products within the previous month
• Clinically abnormal findings at Visit 1
• Concomitant participation in another study protocol

Where it is running

• Physicians Research Group — Tempe, Arizona, United States
• HRC Fertility — Encino, California, United States
• Reproductive Associates of Delaware — Newark, Delaware, United States
• FL Fertility Institution — Tampa, Florida, United States
• Georgia Reproductive Specialists — Atlanta, Georgia, United States
• Fertility Centers of Illinois — Chicago, Illinois, United States
• In Via Fertility Specialists — Hoffman Estate, Illinois, United States
• Shady Grove Fertility RSC — Rockville, Maryland, United States
• Nevada Center for Reproductive Medicine — Reno, Nevada, United States
• Cooper Institute of Reproductive Hormonal Disorders, P.C. — Marlton, New Jersey, United States
• Institute for Reproductive Health — Cincinnati, Ohio, United States
• Abington Reproductive Medicine — Abington, Pennsylvania, United States
• Main Line Fertility Center — Bryn Mawr, Pennsylvania, United States
• Shady Grove Fertility RSC, Chesterbrook, PA — Chesterbrook, Pennsylvania, United States
• University of Penn — Philadelphia, Pennsylvania, United States
• Fertility Associates of Memphis — Memphis, Tennessee, United States
• Texas Fertility Center — Austin, Texas, United States
• Center for Assisted Reproduction — Bedford, Texas, United States
• Fertility Specialists of Houston — Houston, Texas, United States
• Houston Fertility Institute — Houston, Texas, United States
• Center of Reproducitve Medicine — Webster, Texas, United States
• Jones Institute for Reproductive Medicine — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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