Oocyte DonationPhase 3NCT01785095
Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles
A Phase 3 study testing FSH (Follicle Stimulating Hormone) in people with Oocyte Donation, run by IBSA Institut Biochimique SA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oocyte Donation
- What is being tested?
- FSH (Follicle Stimulating Hormone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Nov 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
Show all 9Show fewer
- 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).
Who cannot join
- 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;
Show all 11Show fewer
- 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…).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Dep.Obstet-Gynec.-Reproduction,Institut Universitari Dexeus
Barcelona, 8028
About this study
Official title: Prospective, Open-label, Uncontrolled Clinical Trial Evaluating Multiple Controlled Ovarian Hyperstimulation Cycles in Oocyte Donor, to Assess the Immunogenicity of FSH-IBSA
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.
- Conditions
- Oocyte Donation
- Being tested
- FSH (Follicle Stimulating Hormone)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSH (Follicle Stimulating Hormone)Drug
| Study group | Role | What they receive |
|---|---|---|
| FSH | Experimental | FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator. Receives: Drug: FSH (Follicle Stimulating Hormone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months.
Secondary outcomes (2)
Number of Oocytes Retrieved
the number of oocytes retrieved in the first cycle and in the second cycle are compared.
Measured: after 2 weeks of treatment
Total Dose of FSH Units Used.
Measured: after 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oocyte DonationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785095
- Sponsor's protocol ID
- 11E/FSH03
- Status last verified
- Dec 2016
- First submitted
- 23 Jan 2013
- Last updated
- 9 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label, Uncontrolled Clinical Trial Evaluating Multiple Controlled Ovarian Hyperstimulation Cycles in Oocyte Donor, to Assess the Immunogenicity of FSH-IBSA
- ClinicalTrials.gov ID
- NCT01785095
- Acronym / sponsor ID
- 11E/FSH03
- Conditions
- Oocyte Donation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Posted 27 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FSH | Experimental | Drug: FSH (Follicle Stimulating Hormone)FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FSH (Follicle Stimulating Hormone) | Drug | FSH |
Primary outcome
Number of Patients Producing Anti-FSH Antibodies.
Time frame: 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.
2 secondary outcomes
Number of Oocytes Retrieved
Time frame: after 2 weeks of treatment
Total Dose of FSH Units Used.
Time frame: after 2 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Oocyte Donation
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
RecruitingObservational study
Aurora Test for ART Donor Patients (AURORA-Donor)
Infertility
Recruiting
Ultra-rapid Blastocyst Vitrification: Pilot Randomized Study
Infertility
Not yet recruitingPhase 4
Exogenous Progesterone as Ovulation Trigger
Ovulation, Ovarian Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FSH (Follicle Stimulating Hormone) in people with Oocyte Donation, run by IBSA Institut Biochimique SA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Producing Anti-FSH Antibodies. (time frame: 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.