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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Fertility Biotech AG Identifier:
First received: September 3, 2012
Last updated: February 17, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Drug: Gonal-f
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Phase III Investigator and Assessor Blinded 1:1 Randomized, Parallel-group Multicenter Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA vs Gonal-f® RFF) in Normal Ovulatory Women 35 to 42 Years Old Undergoing in Vitro Fertilization

Further study details as provided by Fertility Biotech AG:

Primary Outcome Measures:
  • Clinical pregnancy [ Time Frame: Six weeks post embryo transfer ]
    Clinical pregnancy is defined as presence of a gestational sac and fetal heart activity beginning at six weeks post embryo transfer

Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Measurement at baseline, 8, 21 and 60 days after start of r-hFSH therapy ]
    Measurement of possible antibodies against exogenous r-hFSH

  • Local and systemic adverse events [ Time Frame: Systemic adverse events: Screening visit until approx. 40 weeks after the confirmation of biochemical pregnancy. Local adverse events: up to a max. of 16 days after the start of the FSH treatment ]
    Evaluation of possible local adverse events due to subcutaneous injections, such as erythema, hematoma, induration etc. using a patient diary. Assessment of systemic adverse events incl. ovarian hyperstimulation syndrome (OHSS) by physical examination and laboratory assessments.

  • Pregnancy outcome [ Time Frame: Follow-up period starting the time of confirmation of clinical pregnancy until 40 weeks after confirmation of biochemical pregnancy (birth) ]
    Follow-up of ongoing pregnancy from date of confirmation of clinical pregnancy until birth including neonatal phase of 28 days

Estimated Enrollment: 1100
Study Start Date: December 2013
Estimated Study Completion Date: April 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gonal-f RFF
One subcutaneous injection of 225IU Gonal-f (follitropin-alfa) per day (initial dose) for the first 6 days. Increase of dose to a maximum of 450IU per day after initial dosing period if deemed necessary
Drug: Gonal-f
225IU subcutaneously, starting at the day of successful down-regulation for the first 6 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached
Other Name: Follitropin-alfa
Experimental: AFOLIA
One subcutaneous injection of 225IU AFOLIA (follitropin-alfa) per day (initial dose) for the first 6 days. Increase of dose to a maximum of 450IU per day after initial dosing period if deemed necessary
225IU subcutaneously, starting at the day of successful down-regulation for the first 6 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached
Other Name: Follitropin-alfa

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.

Ages Eligible for Study:   35 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01687712

United States, Arizona
Physicians Research Group
Tempe, Arizona, United States, 85284
United States, California
HRC Fertility
Encino, California, United States, 91436
United States, Delaware
Reproductive Associates of Delaware
Newark, Delaware, United States, 19713
United States, Florida
FL Fertility Institution
Tampa, Florida, United States, 33759
United States, Georgia
Georgia Reproductive Specialists
Atlanta, Georgia, United States, 30342
United States, Illinois
Fertility Centers of Illinois
Chicago, Illinois, United States, 60610
In Via Fertility Specialists
Hoffman Estates, Illinois, United States, 60169
United States, Maryland
Shady Grove Fertility RSC
Rockville, Maryland, United States, 20850
United States, Nevada
Nevada Center for Reproductive Medicine
Reno, Nevada, United States, 89519
United States, New Jersey
Cooper Institute of Reproductive Hormonal Disorders, P.C.
Marlton, New Jersey, United States, 08053
United States, Ohio
Institute for Reproductive Health
Cincinnati, Ohio, United States, 45209
United States, Pennsylvania
Abington Reproductive Medicine
Abington, Pennsylvania, United States, 19001
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States, 19010
Shady Grove Fertility RSC, Chesterbrook, PA
Chesterbrook, Pennsylvania, United States, 19087
University of Penn
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Fertility Associates of Memphis
Memphis, Tennessee, United States, 38120
United States, Texas
Texas Fertility Center
Austin, Texas, United States, 78731
Center for Assisted Reproduction
Bedford, Texas, United States, 75022
Fertility Specialists of Houston
Houston, Texas, United States, 77054
Houston Fertility Institute
Houston, Texas, United States, 77063
Center of Reproducitve Medicine
Webster, Texas, United States, 77598
United States, Virginia
Jones Institute for Reproductive Medicine
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Fertility Biotech AG
Principal Investigator: Kevin Doody, MD Center for Assisted Reproduction, Bedford, Texas
  More Information

Additional Information:
Responsible Party: Fertility Biotech AG Identifier: NCT01687712     History of Changes
Other Study ID Numbers: FIN3002
Study First Received: September 3, 2012
Last Updated: February 17, 2017

Keywords provided by Fertility Biotech AG:
In vitro fertilization
Controlled ovarian stimulation

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 24, 2017