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

• Status: Completed
• Trial end date: 2016-11-14
• Target enrollment: 0
• Participant gender: Female

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 Gonal-f® RFF.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fertility Biotech AG; Finox AG
• Treatments: Follicle Stimulating Hormone

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