A Phase 3 interventional study of FSH (Follicle Stimulating Hormone) in Oocyte Donation, sponsored by IBSA Institut Biochimique SA. Completed at 1 site in Spain. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-09.
Sponsored by IBSA Institut Biochimique SA · Phase 3, Interventional, and Treatment
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.
IBSA Institut Biochimique SA is the lead sponsor of 33 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.
Drug: FSH (Follicle Stimulating Hormone)
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.
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
Total Dose of FSH Units Used.
Time frame: after 2 weeks of treatment
| Milestone | Follicle Stimulation Hormone |
|---|---|
| Started | 27 |
| Completed | 24 |
| Not completed | 3 |
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.
| participants | Follicle Stimulationg Hormone |
|---|---|
| Number of Patients Producing Anti-FSH Antibodies. | 0 |
the number of oocytes retrieved in the first cycle and in the second cycle are compared.
| oocytes | First Cycle | Second Cycle |
|---|---|---|
| Number of Oocytes Retrieved | 13.4 ± 7.7 | 15.7 ± 7.8 |
| IU | First Cycle | Second Cycle |
|---|---|---|
| Total Dose of FSH Units Used. | 1911.1 ± 604.8 | 1984.4 ± 622.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Follicle Stimulating Hormone | — | 1/27 (3.7%) | 7/27 (25.9%) |
| Event | Follicle Stimulating Hormone |
|---|---|
| HaemorrhageInjury, poisoning and procedural complications | 1/27 |
| Event | Follicle Stimulating Hormone |
|---|---|
| HeadhacheNervous system disorders | 3/27 |
| abdominal painGastrointestinal disorders | 1/27 |
| PirexiaGeneral disorders | 1/27 |
| bacterial vaginosisInfections and infestations | 1/27 |
| candida infectionInfections and infestations | 1/27 |
| lymp injuryInjury, poisoning and procedural complications | 1/27 |
| Back painMusculoskeletal and connective tissue disorders | 1/27 |
| Muscle spasmMusculoskeletal and connective tissue disorders | 1/27 |
| DizzinessNervous system disorders | 1/27 |
All the subjects that started the stimulation.
| Age, Continuous(years) | Follicle Stimulating Hormone |
|---|---|
| Mean | 25.7 ± 5.4 |
| Gender(Participants) | Follicle Stimulating Hormone |
|---|---|
| Female | 27 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Follicle Stimulating Hormone |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 27 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| BMI (kg/m2)(kg/m2) | Follicle Stimulating Hormone |
|---|---|
| Mean | 21.7 ± 2.0 |
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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IBSA Institut Biochimique SA