Trial Outcomes & Findings for Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles (NCT NCT01785095)

Last Updated: 2017-02-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

41 participants

Primary outcome timeframe

4 months.

Results posted on

2017-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	27
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Follicle Stimulating Hormone n=27 Participants
Age, Continuous	25.7 years STANDARD_DEVIATION 5.4 • n=5 Participants
Gender Female	27 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
BMI (kg/m2)	21.7 kg/m2 STANDARD_DEVIATION 2.0 • n=5 Participants

PRIMARY outcome

Timeframe: 4 months.

Population: presence of Antibodies against FSH

Outcome measures

Outcome measures
Measure	Follicle Stimulationg Hormone n=27 Participants	Second Cycle Second treatment cycle performed after 1 month of wash out.
Number of Patients Producing Anti-FSH Antibodies.	0 participants	—

SECONDARY outcome

Timeframe: after 2 weeks of treatment

the number of oocytes retrieved in the first cycle and in the second cycle are compared.

Outcome measures

Outcome measures
Measure	Follicle Stimulationg Hormone n=27 Participants	Second Cycle n=24 Participants Second treatment cycle performed after 1 month of wash out.
Number of Oocytes Retrieved	13.4 oocytes Standard Deviation 7.7	15.7 oocytes Standard Deviation 7.8

SECONDARY outcome

Timeframe: after 2 weeks of treatment

Outcome measures

Outcome measures
Measure	Follicle Stimulationg Hormone n=27 Participants	Second Cycle n=24 Participants Second treatment cycle performed after 1 month of wash out.
Total Dose of FSH Units Used.	1911.1 IU Standard Deviation 604.8	1984.4 IU Standard Deviation 622.4

Adverse Events

Follicle Stimulating Hormone

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Follicle Stimulating Hormone n=27 participants at risk
Injury, poisoning and procedural complications Haemorrhage	3.7% 1/27 • Number of events 1

Other adverse events

Other adverse events
Measure	Follicle Stimulating Hormone n=27 participants at risk
Gastrointestinal disorders abdominal pain	3.7% 1/27 • Number of events 2
General disorders Pirexia	3.7% 1/27 • Number of events 1
Infections and infestations bacterial vaginosis	3.7% 1/27 • Number of events 1
Infections and infestations candida infection	3.7% 1/27 • Number of events 1
Injury, poisoning and procedural complications lymp injury	3.7% 1/27 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	3.7% 1/27 • Number of events 1
Musculoskeletal and connective tissue disorders Muscle spasm	3.7% 1/27 • Number of events 1
Nervous system disorders Dizziness	3.7% 1/27 • Number of events 1
Nervous system disorders Headhache	11.1% 3/27 • Number of events 3

Additional Information

IBSA Clinical Research Manager

IBSA Institut Biochimique SA

Phone: +41583601000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place