No Explained SterilityPhase 4NCT01376999
Step Up Versus Step Down in Controlled Ovarian Stimulation
A Phase 4 study testing FSH-r (Follicule stimulate hormone) in people with No Explained Sterility, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The aim of the study is to evaluate if the Step up protocol is equal or superior regarding efficacy and security than the step down protocol. In couple submitted two intrauterine insemination. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- No Explained Sterility
- What is being tested?
- FSH-r (Follicule stimulate hormone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2010to Feb 2014
- 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 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with unexplained sterility with needs of intrauterine insemination.
Who cannot join
- Contraindications to intrauterine insemination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Step Up Versus Step Down in Controlled Ovarian Stimulation for Intrauterine Insemination. A Controlled Randomised Trial.
The aim of the study is to evaluate if the Step up protocol is equal or superior regarding efficacy and security than the step down protocol. In couple submitted two intrauterine insemination.
- Conditions
- No Explained Sterility
- Being tested
- FSH-r (Follicule stimulate hormone)
- Keywords
- Sterility, FSH-r, intrauterine insemination, unexplained sterility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSH-r (Follicule stimulate hormone)Drug
Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r
| Study group | Role | What they receive |
|---|---|---|
| Step Down | Experimental | Step Down: We begin the COS (controlled ovarian stimulation) with 150 IU of FSH-r until 7th day of stimulation. This day we make an adjustment reducing the dose if necessary. Receives: Drug: FSH-r (Follicule stimulate hormone) |
| Step Up | Active comparator | Step up: We begin the COS (controlled ovarian stimulation) with 75 IU of FSH-r until 7th day of stimulation.This day we make an adjustment increasing the dose if necessary. Receives: Drug: FSH-r (Follicule stimulate hormone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for No Explained SterilityStudies 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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Angel Checa, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376999
- Sponsor's protocol ID
- UREP-01-2009
- Status last verified
- Sep 2017
- First submitted
- 17 Jun 2011
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Robles A, Gayete-Lafuente S, Prat M, Gonzalez-Comadran M, Checa MA. The step-up protocol increases clinical pregnancy rates compared with the step-down in patients with unexplained infertility. A randomized controlled trial. JBRA Assist Reprod. 2022 Nov 9;26(4):599-605. doi: 10.5935/1518-0557.20210112.
PubMed 35243855
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Up Versus Step Down in Controlled Ovarian Stimulation for Intrauterine Insemination. A Controlled Randomised Trial.
- ClinicalTrials.gov ID
- NCT01376999
- Acronym / sponsor ID
- UREP-01-2009
- Conditions
- No Explained Sterility
- Keywords
- Sterility, FSH-r, intrauterine insemination, unexplained sterility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Jun 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.
The aim of the study is to evaluate if the Step up protocol is equal or superior regarding efficacy and security than the step down protocol. In couple submitted two intrauterine insemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step Down | Experimental | Drug: FSH-r (Follicule stimulate hormone)Step Down: We begin the COS (controlled ovarian stimulation) with 150 IU of FSH-r until 7th day of stimulation. This day we make an adjustment reducing the dose if necessary. |
| Step Up | Active comparator | Drug: FSH-r (Follicule stimulate hormone)Step up: We begin the COS (controlled ovarian stimulation) with 75 IU of FSH-r until 7th day of stimulation.This day we make an adjustment increasing the dose if necessary. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with unexplained sterility with needs of intrauterine insemination.
Key exclusion criteria (1 listed)
- Contraindications to intrauterine insemination.
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-r (Follicule stimulate hormone)Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r | Drug | Step Down, Step Up |
Primary outcome
Ovulation rate
Time frame: 1 month
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 20 Sep 2017.
- Derived from this study: PubMed 35243855Robles A, Gayete-Lafuente S, Prat M, Gonzalez-Comadran M, Checa MA. The step-up protocol increases clinical pregnancy rates compared with the step-down in patients with unexplained infertility. A randomized controlled trial. JBRA Assist Reprod. 2022 Nov 9;26(4):599-605. doi: 10.5935/1518-0557.20210112.
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 4 study testing FSH-r (Follicule stimulate hormone) in people with No Explained Sterility, run by Parc de Salut Mar 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 1 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 20 Sep 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 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?
Ovulation rate (time frame: 1 month). 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 NCT01376999, which also lists 1 linked publication.
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 20 Sep 2017.