Phase 3
Completed N=270
Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
Source: ClinicalTrials.gov NCT01312766 ↗Enrolled (actual)
270
Serious AEs
4.8%
Results posted
Aug 2014
Primary outcomePrimary: Total Number of Oocytes Retrieved — 11.6; 9.7 number of oocytes — p=0.012
Summary
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Oocytes Retrieved |
11.6; 9.7 | 0.012 sig |
| SECONDARY Mean hMG Dose (Total); |
2171.4; 2303.6 | 0.25 |
| SECONDARY Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo) |
63.3; 63.3 | — |
| SECONDARY Positive b-hCG Test |
43.7; 45.2 | 0.90 |
| SECONDARY Controlled Ovarian Stimulation Duration (Days) |
10.2; 10.6 | 0.02 sig |
| SECONDARY 17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection; |
2613.8; 2364.0 | — |
| SECONDARY Implantation Rate |
29.1; 28.2 | — |
| SECONDARY Clinical Pregnancy Rate, |
33.3; 37.1 | 0.61 |
| SECONDARY Number of Mature (Grade III Metaphase II) Oocytes Retrieved. |
10.3; 8.2 | 0.002 sig |
| SECONDARY Ratio Mature/Total Number of Oocytes Retrieved. |
85; 81 | 0.004 sig |
| SECONDARY Total Number of Inseminated Oocytes (IVF and ICSI) |
10.8; 8.4 | <0.001 sig |
| SECONDARY Number of Cleaved Embryos |
5.8; 4.8 | 0.04 sig |
| SECONDARY Live Birth Rate |
32.6; 36.3 | 0.61 |
Eligibility Criteria
Inclusion Criteria
- Women undergoing ovarian stimulation for IVF with the following characteristics:
- Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule
- >18 and 40 years
- primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration 10 mm
- hydrosalpinx that have not been surgically removed or ligated;
- stage 3 or 4 endometriosis
- oocyte donation
- implantation of previously frozen embryos
- patients affected by pathologies associated with any contraindication of being pregnant
- hypersensitivity to the study medication
- abnormal bleeding of undetermined origin
- uncontrolled thyroid or adrenal dysfunction
- neoplasias
- severe impairment of renal and/or hepatic function
- use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)
Data sourced from ClinicalTrials.gov (NCT01312766). 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.