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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) (FIN3002)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Finox AG
Sponsor:
Information provided by (Responsible Party):
Finox AG
ClinicalTrials.gov Identifier:
NCT01687712
First received: September 3, 2012
Last updated: February 17, 2015
Last verified: February 2015
  Purpose

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
Infertility
Drug: Gonal-f
Drug: AFOLIA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Finox AG:

Primary Outcome Measures:
  • Clinical pregnancy [ Time Frame: Six weeks post embryo transfer ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    Follow-up of ongoing pregnancy from date of confirmation of clinical pregnancy until birth including neonatal phase of 28 days


Estimated Enrollment: 1106
Study Start Date: December 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: June 2015 (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
Drug: AFOLIA
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.

  Eligibility

Ages Eligible for Study:   35 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01687712

Contacts
Contact: Mike Floyd 301 651 4256 mfloyd@lsmgrp.com

  Show 25 Study Locations
Sponsors and Collaborators
Finox AG
Investigators
Principal Investigator: Kevin Doody, MD Center for Assisted Reproduction, Bedford, Texas
  More Information

Additional Information:
No publications provided

Responsible Party: Finox AG
ClinicalTrials.gov Identifier: NCT01687712     History of Changes
Other Study ID Numbers: FIN3002
Study First Received: September 3, 2012
Last Updated: February 17, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Finox AG:
IVF
In vitro fertilization
Controlled ovarian stimulation
Follitropin
AFOLIA
Finox

Additional relevant MeSH terms:
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 27, 2015