Phase 3
N=1,100
Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01687712 ↗Enrolled (actual)
1,100
Serious AEs
5.4%
Results posted
Oct 2017
Primary outcome: Primary: Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population — 114; 138; 435; 413 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AFOLIA (Drug); Gonal-f® RFF (Drug)
- Age
- Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Fertility Biotech AG
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population |
114; 138; 435; 413 | — |
| PRIMARY Clinical Pregnancy Rate After One Cycle of Treatment - PP Population |
108; 125; 378; 369 | — |
| SECONDARY Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1 |
10.8; 11.0 | — |
| SECONDARY Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1 |
3209.2; 3343.6 | — |
| SECONDARY Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1 |
292.1; 297.5 | — |
| SECONDARY Number of Oocytes Retrieved - Cycle 1 |
11.3; 11.2 | 0.612 |
| SECONDARY Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1 |
37; 42; 512; 509 | — |
| SECONDARY Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1 |
28; 25; 2; 7; 0; 1 | — |
| SECONDARY Overall Summary of Adverse Events (AEs) - Cycle 1 |
403; 391; 202; 197; 32; 31 | — |
| SECONDARY Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1 |
13; 12; 6; 4; 5; 6 | — |
| SECONDARY Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2 |
1; 3; 1; 1; 0; 2 | — |
| SECONDARY Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1 |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3 |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility 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 20 follicles with a diameter 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
Data sourced from ClinicalTrials.gov (NCT01687712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.