Overview

This trial is active, not recruiting.

Condition infertility
Treatments gonal-f, afolia
Phase phase 3
Sponsor Finox AG
Start date December 2013
End date April 2016
Trial size 1100 participants
Trial identifier NCT01687712, FIN3002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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
gonal-f Follitropin-alfa
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
(Experimental)
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
afolia Follitropin-alfa
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

Primary Outcomes

Measure
Clinical pregnancy
time frame: Six weeks post embryo transfer

Secondary Outcomes

Measure
Immunogenicity
time frame: Measurement at baseline, 8, 21 and 60 days after start of r-hFSH therapy
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
Pregnancy outcome
time frame: Follow-up period starting the time of confirmation of clinical pregnancy until 40 weeks after confirmation of biochemical pregnancy (birth)

Eligibility Criteria

Female participants from 35 years up to 42 years old.

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

Additional Information

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)
Principal investigator Kevin Doody, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Finox AG.