InfertilityPhase 4NCT01992731
IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial.
A Phase 4 study testing Drug: Follitropine Bèta in people with Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. Read more about this study
- Who is it for?
- Ages 38 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Drug: Follitropine Bèta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2014to Mar 2017
- 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 38 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between 38 and 42 years. Sperm: use of donor sperm or husband sperm reaching WHO criteria 2010.
Who cannot join
- Tubal infertility (even one tube).
- Major uterine or ovarian abnormalities
- Metabolic abnormalities
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UniversitairZB
Jette
Michael De Brucker, MD, 024776699, mdebruck@vub.ac.be
003224776699
About this study
Official title: IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial
Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years.
Read the detailed description
Study design:
Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. .
Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD).
vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol.
- Conditions
- Infertility
- Being tested
- Drug: Follitropine Bèta
- Keywords
- Age (38-42 years), pregnancy rates, 3 IUI cycles, 1 IVF/ICSI cycle
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Follitropine BètaOther
| Study group | Role | What they receive |
|---|---|---|
| IUI group | Active comparator | Group 1: Patients undergo a standard treatment with 3 consecutive gonadotrophin stimulated IUI cycles Intervention: treatment choice and drug:(Follitropine Bèta, Puregon, MSD).
vs. Receives: Other: Drug: Follitropine Bèta |
| IVF/ICSI arm | Active comparator | Group 2: 1 Patients start immediately with IVF/ICSI instead of IUI. A standard antagonist protocol with treatment with a recombinant FSH (Follitropine Bèta, Puregon, MSD) is used.
Intervention: treatment choice and drug: recombinant FSH (Follitropine Bèta, Puregon, Receives: Other: Drug: Follitropine Bèta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Study design:
Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years.
Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD).
vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol.
Primary endpoint:
Comparison of the cumulative ongoing pregnancy rates after 3 IUI cycles versus 1 IVF/ICSI cycle.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael De Brucker, Universitair Ziekenhuis Brussel
- Investigators
- Michael De Brucker, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992731
- Sponsor's protocol ID
- IUI versus IVF/ICSI
- Status last verified
- Mar 2015
- First submitted
- 12 Nov 2013
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01992731
- Acronym / sponsor ID
- IUI versus IVF/ICSI
- Conditions
- Infertility
- Keywords
- Age (38-42 years), pregnancy rates, 3 IUI cycles, 1 IVF/ICSI cycle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 25 Nov 2013 (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.
Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years.
Detailed description
Study design:
Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. .
Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD).
vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IUI group | Active comparator | Other: Drug: Follitropine BètaGroup 1: Patients undergo a standard treatment with 3 consecutive gonadotrophin stimulated IUI cycles Intervention: treatment choice and drug:(Follitropine Bèta, Puregon, MSD). vs. |
| IVF/ICSI arm | Active comparator | Other: Drug: Follitropine BètaGroup 2: 1 Patients start immediately with IVF/ICSI instead of IUI. A standard antagonist protocol with treatment with a recombinant FSH (Follitropine Bèta, Puregon, MSD) is used. Intervention: treatment choice and drug: recombinant FSH (Follitropine Bèta, Puregon, |
Who may qualify
- Ages
- 38 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged between 38 and 42 years. Sperm: use of donor sperm or husband sperm reaching WHO criteria 2010.
Key exclusion criteria (3 listed)
- Tubal infertility (even one tube).
- Major uterine or ovarian abnormalities
- Metabolic abnormalities
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 |
|---|---|---|
| Drug: Follitropine Bèta | Other | IUI group, IVF/ICSI arm |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks
Study design: Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD). vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol. Primary endpoint: Comparison of the cumulative ongoing pregnancy rates after 3 IUI cycles versus 1 IVF/ICSI cycle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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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.
Michael De Brucker, MD principal investigator
Universitair Ziekenhuis Brussel
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 Drug: Follitropine Bèta in people with Infertility, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 3 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 27 Mar 2015. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 12 weeks). 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 27 Mar 2015.