InfertilityPhase 3NCT02542280
Does Endometrial Injury Improve Intrauterine Insemination Outcome?
A Phase 3 study testing endometrial injury., intrauterine insemination and ovarian stimulation in people with Infertility, run by Ain Shams Maternity Hospital.
Trial summary
The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- endometrial injury., intrauterine insemination and ovarian stimulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Sep 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 - 38 years.
- patent fallopian tunes.
- mild male factor.
- anovulation.
- unexplained infertility.
Who cannot join
- indications for ICSI.
- evidence of pelvic inflammatory disease.
About this study
Official title: Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination
The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.
Read the detailed description
In a selected group of patients with repeated implantation failure, endometrial injury in the preceding cycle may improve ICSI outcome.
Little is known about the efficacy of this procedure in improving intrauterine insemination outcome.
Also little is known about the effect of this procedure if done in the stimulation cycle weather in ICSI or intrauterine insemination cycles.
- Conditions
- Infertility
- Being tested
- endometrial injury., intrauterine insemination, ovarian stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial injury.Procedure or surgery
Also called endometrial scratch., endometrial sample.
Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
intrauterine inseminationProcedure or surgery
Also called artificial insemination
Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulationDrug
Also called controlled ovarian hyperstimulatiom
Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.
| Study group | Role | What they receive |
|---|---|---|
| endometrial injury | Experimental | Endometrial injury during ovarian stimulation combined with intrauterine insemination. Receives: Procedure: endometrial injury.; Procedure: intrauterine insemination; Drug: ovarian stimulation |
| no endometrial injury | Active comparator | Ovarian stimulation combined with intrauterine insemination. Receives: Procedure: intrauterine insemination; Drug: ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemical Pregnancy Rate
Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.
Measured: two weeks after intrauterine insemination
Clinical Pregnancy Rate
Ultrasound detection of an intrauterine positive fetal heart pulsations
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital
- Investigators
- Ahmed Bahaa, Principal investigator, Lecturer in Obstetrics and Gynecology, faculty of medicine, Ain Shams University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542280
- Sponsor's protocol ID
- abahaa050301
- Status last verified
- Nov 2015
- First submitted
- 3 Sep 2015
- Last updated
- 8 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Injury May Increase the Pregnancy Rate in Patients Undergoing Intrauterine Insemination
- ClinicalTrials.gov ID
- NCT02542280
- Acronym / sponsor ID
- abahaa050301
- Conditions
- Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 8 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.
Detailed description
In a selected group of patients with repeated implantation failure, endometrial injury in the preceding cycle may improve ICSI outcome.
Little is known about the efficacy of this procedure in improving intrauterine insemination outcome.
Also little is known about the effect of this procedure if done in the stimulation cycle weather in ICSI or intrauterine insemination cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endometrial injury | Experimental | Procedure: endometrial injury., Procedure: intrauterine insemination, Drug: ovarian stimulationEndometrial injury during ovarian stimulation combined with intrauterine insemination. |
| no endometrial injury | Active comparator | Procedure: intrauterine insemination, Drug: ovarian stimulationOvarian stimulation combined with intrauterine insemination. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 - 38 years.
- patent fallopian tunes.
- mild male factor.
- anovulation.
- unexplained infertility.
Key exclusion criteria (2 listed)
- indications for ICSI.
- evidence of pelvic inflammatory disease.
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 |
|---|---|---|
| endometrial injury.Also: endometrial scratch., endometrial sample.Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination. | Procedure or surgery | endometrial injury |
| intrauterine inseminationAlso: artificial inseminationPlacement of washed sperm in the uterus using a catheter, around the time of ovulation. | Procedure or surgery | endometrial injury, no endometrial injury |
| ovarian stimulationAlso: controlled ovarian hyperstimulatiomInducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm. | Drug | endometrial injury, no endometrial injury |
Primary outcome
Chemical Pregnancy Rate
Time frame: two weeks after intrauterine insemination
Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.
Clinical Pregnancy Rate
Time frame: six weeks
Ultrasound detection of an intrauterine positive fetal heart pulsations
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ahmed Bahaa principal investigator
Lecturer in Obstetrics and Gynecology, faculty of medicine, Ain Shams University.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing endometrial injury., intrauterine insemination and ovarian stimulation in people with Infertility, run by Ain Shams Maternity Hospital.
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 2 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 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Chemical Pregnancy Rate (time frame: two weeks after intrauterine insemination). The study lists 2 primary outcomes in all. 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 8 Jan 2016.