Phase 3
N=372
Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01121666 ↗Enrolled (actual)
372
Serious AEs
4.0%
Results posted
Apr 2016
Primary outcome: Primary: Number of Oocytes Retrieved (Per Protocol Population) — 10.8; 10.6 Number of retrieved oocytes — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Follitropin alfa (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Finox AG
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Oocytes Retrieved (Per Protocol Population) |
10.8; 10.6 | 0.0003 sig |
| PRIMARY Number of Oocytes Retrieved (Intention-to-treat Population) |
10.7; 10.4 | 0.0003 sig |
| SECONDARY Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation |
11.8; 11.1; 8.3; 7.7; 4.9; 4.5 | 0.2357 |
| SECONDARY E2 Concentration at Day 8 and at Day of hCG Administration |
8982.3; 7704.2; 3958.9; 3234.0 | — |
| SECONDARY Total Dose of r-hFSH Administered |
1555.7; 1569.2 | 0.9638 |
| SECONDARY Quality of Oocytes Retrieved |
9.5; 9.1; 7.2; 7.7; 83.4; 83.3 | — |
| SECONDARY Fertilisation Rate of Oocytes |
66.1; 64.0 | — |
| SECONDARY Embryo Quality: Mean Number of Blastomeres |
6.6; 6.4 | — |
| SECONDARY Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts |
103; 55 | — |
| SECONDARY Number of Days of r-hFSH Stimulation |
10.6; 10.7 | 0.8926 |
| SECONDARY Number of Patients With Cycle Cancellation |
13; 5 | — |
| SECONDARY Number of Patients With Good Response |
217; 107 | — |
| SECONDARY Implantation Rate |
31.8; 36.7 | — |
| SECONDARY Clinical Pregnancy Rate |
90; 55 | — |
| SECONDARY Ongoing Pregnancy |
84; 51 | — |
| SECONDARY Live Birth Rate |
80; 51 | — |
| SECONDARY Embryo Quality: Absence of Multinucleation |
93.6; 93.9 | — |
| SECONDARY Quality of Oocytes Retrieved |
9.5; 9.1; 7.2; 7.7; 83.4; 83.3 | — |
| SECONDARY Quality of Oocytes Retrieved |
9.5; 9.1; 7.2; 7.7; 83.4; 83.3 | — |
| SECONDARY Clinical Pregnancy Rate (Second Treatment Cycle) |
25; 10 | — |
| SECONDARY Ongoing Pregnancy (Second Treatment Cycle) |
22; 9 | — |
| SECONDARY Quality of Oocytes Retrieved |
9.5; 9.1; 7.2; 7.7; 83.4; 83.3 | — |
| SECONDARY Quality of Oocytes Retrieved |
9.5; 9.1; 7.2; 7.7; 83.4; 83.3 | — |
Summary
Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.
Eligibility Criteria
Inclusion Criteria
- Age between 20 and 38 years with regular menstrual cycles of 25-35 days
- First or second cycle in the present series of ART
- BMI ≥ 18 ≤ 30 kg/m2
- Basal FSH 10 cigarettes/day)
- Administration of other investigational products within the last month
- Clinically abnormal findings at Visit 1
- Planned PGS/PGD/PBB or assisted hatching
- Concomitant participation in an other study protocol
- 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 medication (GnRH agonist, vitrelle®, and Utrogestan®)
- Presence or history of thrombophlebitis or thromboembolic disorders
- Presence or history of cerebral haemorrhage
- Presence or history of porphyria
Data sourced from ClinicalTrials.gov (NCT01121666). 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.