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The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FSH | Experimental | FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FSH (Follicle Stimulating Hormone) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Producing Anti-FSH Antibodies. | The immunogenicity potential of FSH in healthy volunteer will be assessed by analysing serum samples collected at different timepoints during two treatment cycle for oocytes donation: cycle 1, serum samples will be collected before treatment start (baseline), after 7-13 days and after 28 days of treatment; Cycle 2: serum samples will be collected before starting the second cycle (baseline 2), after 7-13 days and after 28 days of treatment. Cycle 1 and cycle 2 will be separated by a wash-out period of two months. | 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Oocytes Retrieved | the number of oocytes retrieved in the first cycle and in the second cycle are compared. | after 2 weeks of treatment |
| Total Dose of FSH Units Used. | after 2 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep.Obstet-Gynec.-Reproduction,Institut Universitari Dexeus | Barcelona | 8028 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | Follicle Stimulation Hormone | FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator. FSH (Follicle Stimulating Hormone) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All the subjects that started the stimulation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Follicle Stimulating Hormone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Producing Anti-FSH Antibodies. | The immunogenicity potential of FSH in healthy volunteer will be assessed by analysing serum samples collected at different timepoints during two treatment cycle for oocytes donation: cycle 1, serum samples will be collected before treatment start (baseline), after 7-13 days and after 28 days of treatment; Cycle 2: serum samples will be collected before starting the second cycle (baseline 2), after 7-13 days and after 28 days of treatment. Cycle 1 and cycle 2 will be separated by a wash-out period of two months. | presence of Antibodies against FSH | Posted | Number | participants | 4 months. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Follicle Stimulating Hormone |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhage | Injury, poisoning and procedural complications | post oocyte retrieval haemorrhage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| IBSA Clinical Research Manager | IBSA Institut Biochimique SA | +41583601000 | rd@ibsa.com |
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| ID | Term |
|---|---|
| D043373 | Follicle Stimulating Hormone, Human |
| ID | Term |
|---|---|
| D005640 | Follicle Stimulating Hormone |
| D006065 | Gonadotropins, Pituitary |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
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| years |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Oocytes Retrieved | the number of oocytes retrieved in the first cycle and in the second cycle are compared. | Posted | Mean | Standard Deviation | oocytes | after 2 weeks of treatment |
|
|
|
| Secondary | Total Dose of FSH Units Used. | Posted | Mean | Standard Deviation | IU | after 2 weeks of treatment |
|
|
|
| 1 |
| 27 |
| 7 |
| 27 |
| Pirexia | General disorders |
|
| bacterial vaginosis | Infections and infestations |
|
| candida infection | Infections and infestations |
|
| lymp injury | Injury, poisoning and procedural complications |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders |
|
| Dizziness | Nervous system disorders |
|
| Headhache | Nervous system disorders |
|
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| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |