Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF
NCT ID: NCT01687712
Last Updated: 2017-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1100 participants
INTERVENTIONAL
2013-11-25
2016-11-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AFOLIA
One subcutaneous injection of 225IU AFOLIA (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
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
Gonal-f® RFF
One subcutaneous injection of 225IU Gonal-f® RFF (follitropin alfa) per day (initial dose) for the first 5 days. From day 6 dose could be adjusted up (to a max of 450IU per day) or down (to a min of 75IU per day) in multiple increments of 37.5IU.
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
42 Years
FEMALE
No
Sponsors
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Fertility Biotech AG
INDUSTRY
Responsible Party
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Principal Investigators
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Julian Jenkins, DM FRCOG
Role: STUDY_DIRECTOR
Fertility Biotech AG
Locations
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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
Countries
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Other Identifiers
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FIN3002
Identifier Type: -
Identifier Source: org_study_id