PregnancyPhase 4NCT01622023
Timing of Intrauterine Insemination (IUI) 24 or 48 Hours After Spontaneous Luteinizing Hormone (LH) Peak
A Phase 4 study testing intra-uterine insemination in people with Pregnancy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The aim of the present study is to prospectively evaluate whether performing an intra-uterine insemination 24 hours after the spontaneous LH peak may result in significantly higher ongoing pregnancy rates compared to 48 hours. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- intra-uterine insemination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2010to Jun 2013
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- below 39 years of age on the day of LH peak
- donor semen
- natural cycle (without CC)
- cycle with less than 3 follicles reaching 15 mm of diameter or more.
- with basal hormonal values of progesterone ( < 1,2 ng/dl)
Who cannot join
- The patients excluded are women
- who underwent more than 6 intrauterine inseminations,
- with tubal infertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing of IUI 24 or 48 Hours After Spontaneous LH Peak: a Randomised Controlled Trial
The aim of the present study is to prospectively evaluate whether performing an intra-uterine insemination 24 hours after the spontaneous LH peak may result in significantly higher ongoing pregnancy rates compared to 48 hours.
- Conditions
- Pregnancy
- Being tested
- intra-uterine insemination
- Keywords
- insemination, donor sperm, natural cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-uterine inseminationProcedure or surgery
Also called no other interventions
Artificial insemination is the process by which sperm is placed into the reproductive tract of a female for the purpose of impregnating the female by using means other than sexual intercourse or natural insemination.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | intrauterine insemination after 24 hours Receives: Procedure: intra-uterine insemination |
| Control group | Active comparator | intrauterine insemination after 48 hours Receives: Procedure: intra-uterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
Measured: end of 2013 (up to 2 years)
Secondary outcomes (1)
live birth rate
Measured: end of 2013 (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startOct 2010
- Primary completionJun 2013
- Study completionJun 2013
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 PregnancyStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blockeel Christophe, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622023
- Sponsor's protocol ID
- 1/2012
- Status last verified
- Apr 2019
- First submitted
- 27 Mar 2012
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Blockeel C, Knez J, Polyzos NP, De Vos M, Camus M, Tournaye H. Should an intrauterine insemination with donor semen be performed 1 or 2 days after the spontaneous LH rise? A prospective RCT. Hum Reprod. 2014 Apr;29(4):697-703. doi: 10.1093/humrep/deu022. Epub 2014 Feb 18.
PubMed 24549212
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of IUI 24 or 48 Hours After Spontaneous LH Peak: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01622023
- Acronym / sponsor ID
- 1/2012
- Conditions
- Pregnancy
- Keywords
- insemination, donor sperm, natural cycle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Jun 2012 (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 present study is to prospectively evaluate whether performing an intra-uterine insemination 24 hours after the spontaneous LH peak may result in significantly higher ongoing pregnancy rates compared to 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: intra-uterine inseminationintrauterine insemination after 24 hours |
| Control group | Active comparator | Procedure: intra-uterine inseminationintrauterine insemination after 48 hours |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- below 39 years of age on the day of LH peak
- donor semen
- natural cycle (without CC)
- cycle with less than 3 follicles reaching 15 mm of diameter or more.
- with basal hormonal values of progesterone ( < 1,2 ng/dl)
Key exclusion criteria (3 listed)
- The patients excluded are women
- who underwent more than 6 intrauterine inseminations,
- with tubal 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 |
|---|---|---|
| intra-uterine inseminationAlso: no other interventionsArtificial insemination is the process by which sperm is placed into the reproductive tract of a female for the purpose of impregnating the female by using means other than sexual intercourse or natural insemination. | Procedure or surgery | Control group, Study group |
Primary outcome
pregnancy rate
Time frame: end of 2013 (up to 2 years)
1 secondary outcome
live birth rate
Time frame: end of 2013 (up to 2 years)
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 19 Apr 2019.
- Derived from this study: PubMed 24549212Blockeel C, Knez J, Polyzos NP, De Vos M, Camus M, Tournaye H. Should an intrauterine insemination with donor semen be performed 1 or 2 days after the spontaneous LH rise? A prospective RCT. Hum Reprod. 2014 Apr;29(4):697-703. doi: 10.1093/humrep/deu022. Epub 2014 Feb 18.
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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.
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 intra-uterine insemination in people with Pregnancy, 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 5 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: finished, as of the sponsor's last update on 19 Apr 2019. 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?
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?
pregnancy rate (time frame: end of 2013 (up to 2 years)). 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 NCT01622023, 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 19 Apr 2019.