InfertilityPhase 4NCT00374634
Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination
A Phase 4 study testing rFSH drug dose and "Standard" rFSH dose in people with Infertility, run by Nina la Cour Freiesleben at 1 site in Denmark.
Trial summary
The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given in individual doses, according to a nomogram we have constructed based on our results from a previous study, results in more patients maturing 2-3 follicles compared to standard dose. Read more about this study
- Who is it for?
- Ages 25 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- rFSH drug dose and "Standard" rFSH dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Oct 2008
- Phase
- Phase 4
- 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 25 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 25-39 years
- First stimulation with rFSH only
- Indication for intrauterine insemination with standard rFSH starting dose
- Regular menstrual bleeding with a cycle between 21-35 days
- Two ovaries
- Bilateral tuba patency
- Semen analysis must be sufficient for insemination according to the diagnostic analysis.
Who cannot join
- More than three former stimulated intrauterine insemination cycles
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet
Copenhagen East, 2100
About this study
Official title: Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study
The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given in individual doses, according to a nomogram we have constructed based on our results from a previous study, results in more patients maturing 2-3 follicles compared to standard dose.
- Conditions
- Infertility
- Being tested
- rFSH drug dose, "Standard" rFSH dose
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rFSH drug doseDrug
"Individual" rFSH dose (50, 75 or 100 IU rFSH/day)
"Standard" rFSH doseDrug
"Standard" rFSH dose was 75 IU/day
| Study group | Role | What they receive |
|---|---|---|
| "Individual" or "standard" rFSH dose | Active comparator | Patients were randomized to recieve "individual" (50, 75 or 100 IU/day) or "standard" (75 IU/day) rFSh dose. The individual dose was prescribed according to a dosage nomogram based on the patient's body weight (kg) and the total antral follicle count (Freiesleben NC et al., RBMOnline 2009;17:632-64). Receives: Drug: rFSH drug dose |
| "Standard" rFSH dose | Active comparator | "Standard" dose of rFSH Receives: Drug: "Standard" rFSH dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature follicles in the study and control group.
Secondary outcomes (3)
Number of cycles where the rFSH dose is changed.
Number of cycles cancelled or converted to in vitro fertilisation.
Pregnancy rate.
Measured: October 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nina la Cour Freiesleben
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nina la Cour Freiesleben, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Anders N Andersen, Professor,MD, Study director, The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen East, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374634
- Sponsor's protocol ID
- indvFSH2006
- Status last verified
- Sep 2011
- First submitted
- 8 Sep 2006
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
la Cour Freiesleben N, Lossl K, Bogstad J, Bredkjaer HE, Toft B, Rosendahl M, Loft A, Bangsboll S, Pinborg A, Nyboe Andersen A. Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study. Hum Reprod. 2009 Oct;24(10):2523-30. doi: 10.1093/humrep/dep239. Epub 2009 Jul 14.
PubMed 19602518Freiesleben Nl, Rosendahl M, Johannsen TH, Lossl K, Loft A, Bangsboll S, Friis-Hansen L, Pinborg A, Andersen AN. Prospective investigation of serum anti-Mullerian hormone concentration in ovulatory intrauterine insemination patients: a preliminary study. Reprod Biomed Online. 2010 May;20(5):582-7. doi: 10.1016/j.rbmo.2010.02.007. Epub 2010 Feb 12.
PubMed 20303323
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study
- ClinicalTrials.gov ID
- NCT00374634
- Acronym / sponsor ID
- indvFSH2006
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Nina la Cour FreieslebenUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 11 Sep 2006 (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.
The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given in individual doses, according to a nomogram we have constructed based on our results from a previous study, results in more patients maturing 2-3 follicles compared to standard dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Individual" or "standard" rFSH dose | Active comparator | Drug: rFSH drug dosePatients were randomized to recieve "individual" (50, 75 or 100 IU/day) or "standard" (75 IU/day) rFSh dose. The individual dose was prescribed according to a dosage nomogram based on the patient's body weight (kg) and the total antral follicle count (Freiesleben NC et al., RBMOnline 2009;17:632-64). |
| "Standard" rFSH dose | Active comparator | Drug: "Standard" rFSH dose"Standard" dose of rFSH |
Who may qualify
- Ages
- 25 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 25-39 years
- First stimulation with rFSH only
- Indication for intrauterine insemination with standard rFSH starting dose
- Regular menstrual bleeding with a cycle between 21-35 days
- Two ovaries
Key exclusion criteria (1 listed)
- More than three former stimulated intrauterine insemination cycles
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 |
|---|---|---|
| rFSH drug dose"Individual" rFSH dose (50, 75 or 100 IU rFSH/day) | Drug | "Individual" or "standard" rFSH dose |
| "Standard" rFSH dose"Standard" rFSH dose was 75 IU/day | Drug | "Standard" rFSH dose |
Primary outcome
Number of mature follicles in the study and control group.
3 secondary outcomes
Number of cycles where the rFSH dose is changed.
Number of cycles cancelled or converted to in vitro fertilisation.
Pregnancy rate.
Time frame: October 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
- Background: PubMed 19602518la Cour Freiesleben N, Lossl K, Bogstad J, Bredkjaer HE, Toft B, Rosendahl M, Loft A, Bangsboll S, Pinborg A, Nyboe Andersen A. Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study. Hum Reprod. 2009 Oct;24(10):2523-30. doi: 10.1093/humrep/dep239. Epub 2009 Jul 14.
- Derived from this study: PubMed 20303323Freiesleben Nl, Rosendahl M, Johannsen TH, Lossl K, Loft A, Bangsboll S, Friis-Hansen L, Pinborg A, Andersen AN. Prospective investigation of serum anti-Mullerian hormone concentration in ovulatory intrauterine insemination patients: a preliminary study. Reprod Biomed Online. 2010 May;20(5):582-7. doi: 10.1016/j.rbmo.2010.02.007. Epub 2010 Feb 12.
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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.
Anders N Andersen, Professor,MD study director
The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen East, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rFSH drug dose and "Standard" rFSH dose in people with Infertility, run by Nina la Cour Freiesleben at 1 site in Denmark.
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 7 inclusion and 1 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 3 Oct 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 mature follicles in the study and control group.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00374634, which also lists 2 linked publications.
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 3 Oct 2011.