A Phase III Study to Compare Efficacy and Safety of AFOLIA vs. Gonal-f® in Infertile Women 35 to 42 Years of Age Undergoing in Vitro Fertilization (IVF)
Information source: Finox AG
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility
Intervention: Gonal-f (Drug); AFOLIA (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Finox AG Official(s) and/or principal investigator(s): Kevin Doody, MD, Principal Investigator, Affiliation: Center for Assisted Reproduction, Bedford, Texas
Summary
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 the
widely used and marketed r-hFSH Gonal-f.
Clinical Details
Official title: A Phase III Investigator- and Assessor-blinded 1:1 Randomized, Parallel-group Multicenter Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA Pen vs. Gonal-f® RFF Pen) in Normal Ovulatory Women 35 to 42 Years of Age Undergoing in Vitro Fertilization (IVF)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical pregnancy
Secondary outcome: ImmunogenicityLocal and systemic adverse events Pregnancy outcome
Detailed description:
Comparison of the clinical pregnancy rate in the AFOLIA group compared to the Gonal-f group
as the primary endpoint. Comparison of the number and size of follicles, the number of cycle
cancellation, the hormone parameters and adverse events in the AFOLIA group compared to the
Gonal-f group as secondary endpoints.
Eligibility
Minimum age: 35 Years.
Maximum age: 42 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Physicians Research Group, Tempe, Arizona 85284, United States
HRC Fertility, Encino, California 91436, United States
Reproductive Associates of Delaware, Newark, Delaware 19713, United States
FL Fertility Institution, Tampa, Florida 33759, United States
Georgia Reproductive Specialists, Atlanta, Georgia 30342, United States
Fertility Centers of Illinois, Chicago, Illinois 60610, United States
In Via Fertility Specialists, Hoffman Estates, Illinois 60169, United States
Shady Grove Fertility RSC, Rockville, Maryland 20850, United States
Nevada Center for Reproductive Medicine, Reno, Nevada 89519, United States
Cooper Institute of Reproductive Hormonal Disorders, P.C., Marlton, New Jersey 08053, United States
Institute for Reproductive Health, Cincinnati, Ohio 45209, United States
Abington Reproductive Medicine, Abington, Pennsylvania 19001, United States
Main Line Fertility Center, Bryn Mawr, Pennsylvania 19010, United States
Shady Grove Fertility RSC, Chesterbrook, PA, Chesterbrook, Pennsylvania 19087, United States
University of Penn, Philadelphia, Pennsylvania 19104, United States
Fertility Associates of Memphis, Memphis, Tennessee 38120, United States
Texas Fertility Center, Austin, Texas 78731, United States
Center for Assisted Reproduction, Bedford, Texas 75022, United States
Fertility Specialists of Houston, Houston, Texas 77054, United States
Houston Fertility Institute, Houston, Texas 77063, United States
Center of Reproducitve Medicine, Webster, Texas 77598, United States
Jones Institute for Reproductive Medicine, Norfolk, Virginia 23507, United States
Additional Information
The IVY Study Website
Starting date: December 2013
Last updated: April 13, 2015
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