Polycystic Ovary SyndromePhase 2NCT01337531
Recombinant Versus Highly Purified FSH in Polycystic Ovary Syndrome (PCOS)
A Phase 2 study testing Gonal-F, Fostimon in people with Polycystic Ovary Syndrome, run by Genesis Center for Fertility & Human Pre-Implantation Genetics at 1 site in Cyprus.
Trial summary
Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when either recombinant or highly purified follicle stimulating hormone (FSH) is used. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Gonal-F, Fostimon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCyprus
- Study dates
- May 2011to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PCOS
- Primary infertility
- No other fertility manifestation
Who cannot join
- Non PCOS
- Secondary infertility
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
Genesis Centre for Fertility and Human Pre-implantation Genetics
Limassol, 3025
About this study
Official title: Recombinant FSH Versus Highly Purified FSH in PCOS Patients Undergoing Control Ovarian Stimulation and IVF: a Prospective Randomized Study
Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when either recombinant or highly purified follicle stimulating hormone (FSH) is used.
Read the detailed description
Patients will be randomized using sealed and numbered envelopes and will be assigned to receive a similar ovarian stimulation regime incorporating either Gonal-F or highly purified Fostimon as the hormonal analog. Ovarian response using either of the two compounds, pregnancy rates and miscarriage rates will be compared to define possible statistical significance.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Gonal-F, Fostimon
- Keywords
- Ovarian Response in PCOS, pregnancy rate in PCOS, miscarriage rate in PCOS
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonal-F, FostimonDrug
Also called Recombinant Gonadotropin, Highly purified Gonadotropin
dosage form
Gonal-F, FostimonDrug
Also called Gonal-F, Fostimon
injection, daily, 10-15 days
| Study group | Role | What they receive |
|---|---|---|
| gonadotropin | Experimental | recombinant or highly purified gonadotropin Receives: Drug: Gonal-F, Fostimon |
| Gonadotropins | Active comparator | recombinant versus highly purified gonadotropin Receives: Drug: Gonal-F, Fostimon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian Response
Measured: 0-15 days post gonadotropin administration
Secondary outcomes (1)
Pregnancy rate
Measured: 12-15 days post embryo replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genesis Center for Fertility & Human Pre-Implantation Genetics
- Sponsor type
- University, hospital or other
- Investigators
- Savvas N Koundouros, PhD, Principal investigator, Genesis Center for Fertility and Human Pre-implantation Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337531
- Sponsor's protocol ID
- rFSH.- HP-FSH.PCOS
- Status last verified
- Apr 2011
- First submitted
- 14 Apr 2011
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant FSH Versus Highly Purified FSH in PCOS Patients Undergoing Control Ovarian Stimulation and IVF: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01337531
- Acronym / sponsor ID
- rFSH.- HP-FSH.PCOS
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Ovarian Response in PCOS, pregnancy rate in PCOS, miscarriage rate in PCOS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Genesis Center for Fertility & Human Pre-Implantation GeneticsUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Control ovarian stimulation responses, pregnancy and miscarriage rates are indifferent when either recombinant or highly purified follicle stimulating hormone (FSH) is used.
Detailed description
Patients will be randomized using sealed and numbered envelopes and will be assigned to receive a similar ovarian stimulation regime incorporating either Gonal-F or highly purified Fostimon as the hormonal analog. Ovarian response using either of the two compounds, pregnancy rates and miscarriage rates will be compared to define possible statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gonadotropin | Experimental | Drug: Gonal-F, Fostimonrecombinant or highly purified gonadotropin |
| Gonadotropins | Active comparator | Drug: Gonal-F, Fostimonrecombinant versus highly purified gonadotropin |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- PCOS
- Primary infertility
- No other fertility manifestation
Key exclusion criteria (2 listed)
- Non PCOS
- Secondary infertility
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 |
|---|---|---|
| Gonal-F, FostimonAlso: Recombinant Gonadotropin, Highly purified Gonadotropindosage form | Drug | gonadotropin |
| Gonal-F, FostimonAlso: Gonal-F, Fostimoninjection, daily, 10-15 days | Drug | Gonadotropins |
Primary outcome
Ovarian Response
Time frame: 0-15 days post gonadotropin administration
1 secondary outcome
Pregnancy rate
Time frame: 12-15 days post embryo replacement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
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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.
Savvas N Koundouros, PhD principal investigator
Genesis Center for Fertility and Human Pre-implantation Genetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gonal-F, Fostimon in people with Polycystic Ovary Syndrome, run by Genesis Center for Fertility & Human Pre-Implantation Genetics at 1 site in Cyprus.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Apr 2011. 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 Cyprus. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Ovarian Response (time frame: 0-15 days post gonadotropin administration). 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 19 Apr 2011.