Not provided
Not provided
Not provided
Not provided
Lack of funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Instituto Valenciano de Infertilidad, IVI VALENCIA | OTHER |
| IVI Madrid | OTHER |
| IVI Barcelona | OTHER |
A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian stimulation of women with a poor ovarian response undergoing IVF treatments. The main objective of this study is comparing the number of oocytes obtained after the follicle puncture when using each of these two stimulation protocols. Only poor responders according to the Bologna criteria will be recruited for this trial. All participants will undergo two stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the order of application of these protocols will be randomised (crossover clinical trial) in each patient.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | First stimulation cycle with corifollitropin alfa (experimental) Second stimulation cycle with rFSH and HMG (active comparator) |
|
| Group 2 | Other | First stimulation cycle with rFSH and HMG (active comparator) Second stimulation cycle with corifollitropin alfa (experimental) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corifollitropin alfa | Drug | One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of mature oocytes (metaphase II) | Number of mature oocytes (metaphase II) obtained after the follicle puncture | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of oocytes | Total number of oocytes obtained after the follicle puncture | 1 year |
| Symptoms associated with the ovarian stimulation protocol | Patients will evaluate their symptoms using a questionnaire. They will score the intensity (from 1 to 10) of each of the following symptoms: pelvic pain, headache, mood swings, nausea, tiredness, breast pain. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVI Barcelona | Barcelona | Barcelona | 08017 | Spain | ||
| IVI Madrid |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1 year |
| Patient perception of the stimulation treatment | Patients will evaluate how they have perceived the stimulation treatment using a questionnaire. They will score their comfort (from 1 to 10) with the following aspects of the treatment: treatment administration, number of injections and treatment length. | 1 year |
| Length of the stimulation treatment | Days of stimulation treatment | 1 year |
| Number of subcutaneous injections | Number of subcutaneous injections of gonadotropins (corifollitropin alfa, rFSH and HMG) | 1 year |
| Madrid |
| Madrid |
| 28023 |
| Spain |
| IVI Sevilla | Seville | Seville | 41006 | Spain |
| IVI Valencia | Valencia | Valencia | 46015 | Spain |