EndometriosisNCT02636400
Immediate Intra Uterine Isemination (IUI) Versus Expectant Management in Postoperative Endometriosis Patients
A study of Endometriosis and Infertility, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Is postoperative IUI better than expectant management in infertile endometriosis patients with good prognosis based on their EFI score? (A single centre randomised controlled trial). Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Endometriosis, Infertility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to 26 Jan 2018
- Phase
- Interventional
- 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
- recent (<6months) complete laparoscopic endometriosis resection
- endometriosis fertility index (EFI) at least 7/10
- Regular menstrual cycles (min 24days - max 38days) with proven ovulation
- At least one functional tube at surgery, normal uterus
- Sperm sample of partner: normal or mild male factor
Who cannot join
- frozen (donor or partner) sperm
- clinical and/or imaging evidence of endometriosis recurrence/persistence at randomization
- FSH > 20 IU/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Postoperative IUI Better Than Expectant Management in Infertile Endometriosis Patients With Good Prognosis Based on EFI Score?
Is postoperative IUI better than expectant management in infertile endometriosis patients with good prognosis based on their EFI score? (A single centre randomised controlled trial).
- Conditions
- Endometriosis, Infertility
- Being tested
- controlled ovarian stimulation with gonadotropins + intrauterine insemination
- Keywords
- Infertility, endometriosis
- Medical subject headings
- Endometriosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlled ovarian stimulation with gonadotropins + intrauterine inseminationOther
Also called postop IUI
| Study group | Role | What they receive |
|---|---|---|
| expectant | No intervention | 7 menstrual cycles of expectant management |
| postop IUI | Experimental | 4 IUI cycles within 7 menstrual cycles Receives: Other: controlled ovarian stimulation with gonadotropins + intrauterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative clinical pregnancy rate
Measured: participants will be followed for the duration of 7 menstrual cycles and in case of pregnancy, they will be followed until the pregnancy outcome is known, implying an average time frame of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startFeb 2014
- Primary completionJun 2017
- Study completion26 Jan 2018
Why it stopped: Halted prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas D'Hooghe, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636400
- Sponsor's protocol ID
- S55983
- Status last verified
- Jul 2024
- First submitted
- 23 Mar 2015
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Postoperative IUI Better Than Expectant Management in Infertile Endometriosis Patients With Good Prognosis Based on EFI Score?
- ClinicalTrials.gov ID
- NCT02636400
- Acronym / sponsor ID
- S55983
- Conditions
- Endometriosis, Infertility
- Keywords
- Infertility, endometriosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted prematurely
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 21 Dec 2015 (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.
Is postoperative IUI better than expectant management in infertile endometriosis patients with good prognosis based on their EFI score? (A single centre randomised controlled trial).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| expectant | No intervention | –7 menstrual cycles of expectant management |
| postop IUI | Experimental | Other: controlled ovarian stimulation with gonadotropins + intrauterine insemination4 IUI cycles within 7 menstrual cycles |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- recent (<6months) complete laparoscopic endometriosis resection
- endometriosis fertility index (EFI) at least 7/10
- Regular menstrual cycles (min 24days - max 38days) with proven ovulation
- At least one functional tube at surgery, normal uterus
- Sperm sample of partner: normal or mild male factor
Key exclusion criteria (3 listed)
- frozen (donor or partner) sperm
- clinical and/or imaging evidence of endometriosis recurrence/persistence at randomization
- FSH > 20 IU/L
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 |
|---|---|---|
| controlled ovarian stimulation with gonadotropins + intrauterine inseminationAlso: postop IUI | Other | postop IUI |
Primary outcome
cumulative clinical pregnancy rate
Time frame: participants will be followed for the duration of 7 menstrual cycles and in case of pregnancy, they will be followed until the pregnancy outcome is known, implying an average time frame of 1.5 year
Results and safety
The study was stopped early (reason given: Halted prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
Thomas D'Hooghe, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Endometriosis and Infertility, run by Universitaire Ziekenhuizen KU Leuven 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: stopped early, as of the sponsor's last update on 3 Jul 2024. 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.
Are results available for this study?
The study was stopped early (reason given: Halted prematurely). 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?
cumulative clinical pregnancy rate (time frame: participants will be followed for the duration of 7 menstrual cycles and in case of pregnancy, they will be followed until the pregnancy outcome is known, implying an average time frame of 1.5 year). 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 3 Jul 2024.