Phase 3
Completed N=110
Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Infertility, Female
Source: ClinicalTrials.gov NCT03088137 ↗
Enrolled (actual)
110
Serious AEs
3.6%
Results posted
Jun 2019
Primary outcomePrimary: Oocytes (Intention-to-Treat, ITT) — 12.16; 11.62 Number of retrieved oocytes — p=0.002
◆ Published Evidence
Established
26citations · ~4 / year
A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha.
Summary
The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI
Linked Publications (2)
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A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha.
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Association of the Serum Folate and Total Calcium and Magnesium Levels Before Ovarian Stimulation With Outcomes of Fresh <i>In Vitro</i> Fertilization Cycles in Normogonadotropic Women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oocytes (Intention-to-Treat, ITT) |
12.16; 11.62 | 0.002 sig |
| SECONDARY Number of Follicles With Size ≥ 16 mm |
12.09; 11.38 | 0.806 |
| SECONDARY Mature Oocytes |
9.64; 9.86 | 0.617 |
| SECONDARY Fertilised Oocytes |
8.127; 8.764 | 0.445 |
| SECONDARY Percentage of Patients With Embryo Transfer |
11; 9; 38; 40 | 0.623 |
| SECONDARY Total Dose of Follitropin Alfa |
1532.7; 1517.9 | 0.488 |
| SECONDARY Number of Days of Follitropin Alfa Treatment |
9.745; 9.727 | 0.629 |
| SECONDARY Number of Patients With Follitropin Alfa Dose Correction |
13; 11 | 0.644 |
| SECONDARY Number of Patients With Cycle Cancellation |
0; 0 | — |
| SECONDARY Number of No-responders |
0; 0 | — |
| SECONDARY Percentage of Patients With Serum hCG More Than 25 IU/l |
34.7; 36.7 | 0.833 |
| SECONDARY Percentage of Patients With the Evidence for Clinical Pregnancy |
26.5; 32.7 | 0.507 |
Eligibility Criteria
Inclusion Criteria
- Infertility due to tubal factor and/or male factor
- Age between 20 and 35 years with regular menstrual cycles of 21-35 days
- First or second cycle in the present series of ART
- BMI (body mass index) ≥ 18 ≤ 30 kg/m2
- Basal FSH (follicle stimulating hormone) 25 oocytes) responses to FSH treatment at dose 150 IU and GnRH-antagonist (gonadotropin-releasing hormone) protocol
- Premature ovarian failure
- Ectopic pregnancy (3 month before the study cycle)
- Presence of clinically significant systemic disease
- Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
- Presence of endocrine disorder
- Neoplasia
- Male infertility without mobile spermatozoa in the ejaculate, that need MESA (Microsurgical epididymal sperm aspiration)/TESE (testicular sperm extraction)/TESA (testicular sperm aspiration)
- Smoking > 10 cigarettes/day
- Narcomania, alcoholism
- Planned PGS (preimplantation genetic screeneing) /PGD (preimplantation genetic diagnosis)
Data sourced from ClinicalTrials.gov (NCT03088137) and the linked publication. 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. Informational only — not medical advice.