Phase 4
N=710
FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01969201 ↗Enrolled (actual)
710
Serious AEs
7.8%
Results posted
Oct 2019
Primary outcome: Primary: Clinical Pregnancy Rate — 36.93; 39.66 percentage of participants — p=0.49
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Urofollitrophin (Drug); Follitrophin alpha (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- IBSA Institut Biochimique SA
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Pregnancy Rate |
36.93; 39.66 | 0.49 |
| SECONDARY Number of Follicles >16 mm on the Day of hCG Injection |
4.10; 4.47 | 0.003 sig |
| SECONDARY Total Number of Oocytes Retrieved |
8.45; 9.33 | 0.02 sig |
| SECONDARY Fertilization Rate |
73.98; 75.85 | 0.32 |
| SECONDARY Embryo Quality (Number of Top Quality Embryos Transferred Per Patient) |
0.47; 0.48 | 0.89 |
| SECONDARY Positive Serum Pregnancy Test Rate |
47.2; 49.7 | 0.5 |
| SECONDARY Delivery Rate |
34.4; 36.7 | 0.53 |
| SECONDARY Cumulative Pregnancy Rate |
45.2; 52.0 | 0.07 |
Summary
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.
Eligibility Criteria
Inclusion Criteria
- Age: 18-38 years old;
- BMI: 18-28 kg/m2;
- Less than 3 previously completed IVF cycles;
- Basal FSH 10 and 1 ng/ml (7.15 pmol/l) and 10 mm;
- Hydrosalpinx that have not been surgically removed or ligated;
- Endometriosis stage 3 or 4;
- Oocyte donation;
- Severe male factor;
- Pathologies associated with any contraindication of being pregnant;
- History of recurrent miscarriage (more than 3 previous miscarriages);
- Hypersensitivity to the study medication;
- Abnormal bleeding of undetermined origin;
- Uncontrolled thyroid or adrenal dysfunction;
- Neoplasias;
- Severe impairment of renal and/or hepatic function.
Data sourced from ClinicalTrials.gov (NCT01969201). 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.