Oocyte Donation
Conditions
Brief summary
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.
Interventions
DRUGFSH (Follicle Stimulating Hormone)
Sponsors
IBSA Institut Biochimique SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female volunteers undergoing controlled ovarian hyperstimulation for oocyte donation with the following characteristics: * Able and willing to sign the Subject Consent Form and adhere to the study visit schedule; * \>=18 and \<35 years old; * Regular menstrual cycle (26 - 35 days); * BMI between 18 and 30 kg/m2; * First gonadotrophin treatment (i.e. naïve Subjects with regard to exposure to human derived or recombinant gonadotrophins); * basal FSH \<10 IU/L and E2 \<80 pg/ml (\ 290 pmol/l); * Normal TSH levels; * Willing to perform at least two consecutive oocyte retrieval cycles (with a wash out period of two months).
Exclusion criteria
* Age \<18 and \>=35 years; * PCOS; * Endometriosis; * Subjects with evidences of autoimmune or rheumatic diseases; * Hypersensitivity to the active substance or to any of the excipients (lactose); * Abnormal bleeding of undetermined origin; * Subject found to be positive to anti-TSH antibodies (i.e. suffering from thyroidal diseases); * Uncontrolled adrenal dysfunction; * Neoplasia; * Severe impairment of renal and/or hepatic function; * Use of concomitant medications that might interfere with study evaluations (e.g. immunosuppressant, non-study hormonal medications, therapeutics proteins like insulin, growth hormone…).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Producing Anti-FSH Antibodies. | 4 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Oocytes Retrieved | after 2 weeks of treatment | the number of oocytes retrieved in the first cycle and in the second cycle are compared. |
| Total Dose of FSH Units Used. | after 2 weeks of treatment | — |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Follicle Stimulating Hormone | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Follicle Stimulating Hormone |
|---|---|
| Age, Continuous | 25.7 years STANDARD_DEVIATION 5.4 |
| BMI (kg/m2) | 21.7 kg/m2 STANDARD_DEVIATION 2 |
| Gender Female | 27 Participants |
| Gender Male | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 27 |
| serious Total, serious adverse events | 1 / 27 |
Outcome results
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.
Time frame: 4 months.
Population: presence of Antibodies against FSH
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Follicle Stimulationg Hormone | Number of Patients Producing Anti-FSH Antibodies. | 0 participants |
Secondary
Number of Oocytes Retrieved
the number of oocytes retrieved in the first cycle and in the second cycle are compared.
Time frame: after 2 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Follicle Stimulationg Hormone | Number of Oocytes Retrieved | 13.4 oocytes | Standard Deviation 7.7 |
| Second Cycle | Number of Oocytes Retrieved | 15.7 oocytes | Standard Deviation 7.8 |
Secondary
Total Dose of FSH Units Used.
Time frame: after 2 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Follicle Stimulationg Hormone | Total Dose of FSH Units Used. | 1911.1 IU | Standard Deviation 604.8 |
| Second Cycle | Total Dose of FSH Units Used. | 1984.4 IU | Standard Deviation 622.4 |