Unexplained InfertilityNCT02628756
Endometrial Injury in Women With Unexplained Infertility
A study testing Endometrial injury in people with Unexplained Infertility, run by Mansoura Integrated Fertility Center.
Trial summary
Women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year were recruited. In a parallel assignment eligible participants were randomized to receive either a single, site-specific endometrial injury guided by hysteroscopy (Study group) or no intervention (Control group). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- Endometrial injury
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jul 2015
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 39 years old.
- Normal HSG and/or diagnostic laparoscopy.
- Normal seminal profile.
- Regular ovulation confirmed by mid-luteal progesterone.
- Normal TVS criteria.
Who cannot join
- Uterine fibroid.
- Pelvic endometriosis.
- Irregular menstruation.
- Ovarian cysts.
About this study
Official title: Endometrial Injury Does Not Improve Pregnancy Rates in Women With Unexplained Infertility
Women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year were recruited. In a parallel assignment eligible participants were randomized to receive either a single, site-specific endometrial injury guided by hysteroscopy (Study group) or no intervention (Control group). Natural cycle folliculometry + timed sexual intercourse were offered for all participants for the ongoing and the immediate 2 concecutive cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates were the secondary outcome measures.
Read the detailed description
A single site-specific hysteroscopic injury procedure (Snip) will be performed using an office hysteroscopy (Karl Storz, Germany). By means of vaginoscopy, a 2.9 mm. continuous-flow diagnostic hysteroscope with a 5 Fr. working-channel is guided through the cervical canal with normal saline as distension medium, with flow manually regulated through the key of the hysteroscopic sheath.
The examination of the uterine cavity begins by observing its regularity, paying special attention to the presence of intrauterine malformations or morphologic alterations such as submucous myomas, or uterine septa. Subsequently, A claw forceps will be introduced through a 2.2 mm working channel, and will be used to generate a local injury on the upper posterior endometrium (Endometrial Snip) at midline 10-15 mm from the fundus on D4 to D7 of the ongoing menstrual cycle. The depth and width of the injured site will be about 2x2 mm (i.e a single bite of the claw forceps). No premedications, antibiotics or hemostatics will be given after the procedure.
Natural cycle folliculometry + timed sexual intercourse will be offered for all participants for the ongoing and the immediate subsequent cycles. Once the leading ovarian follicle will reach a size of at least 16 mm, 10,000 IU of hCG will be administered to trigger ovulation.
- Conditions
- Unexplained Infertility
- Being tested
- Endometrial injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial injuryProcedure or surgery
Office hysteroscopy (Karl Storz, Tuttlingen, Germany)
| Study group | Role | What they receive |
|---|---|---|
| Endometrial injury | Experimental | Hysteroscopic-guided endometrial injury (Karl Storz, Tuttlingen, Germany). Receives: Procedure: Endometrial injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rates (PR)
Measured: Three consecutive months
Secondary outcomes (1)
Miscarriage rates
Measured: Three consecutive months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startJun 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura Integrated Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Shokeir, Mansoura Integrated Fertility Center
- Investigators
- Tarek Shokeir, M.D., Principal investigator, Mansoura University Hospital, Mansoura Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628756
- Sponsor's protocol ID
- MS/490
- Status last verified
- Dec 2015
- First submitted
- 8 Dec 2015
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Injury Does Not Improve Pregnancy Rates in Women With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT02628756
- Acronym / sponsor ID
- MS/490
- Conditions
- Unexplained Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mansoura Integrated Fertility CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 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.
Women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year were recruited. In a parallel assignment eligible participants were randomized to receive either a single, site-specific endometrial injury guided by hysteroscopy (Study group) or no intervention (Control group). Natural cycle folliculometry + timed sexual intercourse were offered for all participants for the ongoing and the immediate 2 concecutive cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates were the secondary outcome measures.
Detailed description
A single site-specific hysteroscopic injury procedure (Snip) will be performed using an office hysteroscopy (Karl Storz, Germany). By means of vaginoscopy, a 2.9 mm. continuous-flow diagnostic hysteroscope with a 5 Fr. working-channel is guided through the cervical canal with normal saline as distension medium, with flow manually regulated through the key of the hysteroscopic sheath.
The examination of the uterine cavity begins by observing its regularity, paying special attention to the presence of intrauterine malformations or morphologic alterations such as submucous myomas, or uterine septa. Subsequently, A claw forceps will be introduced through a 2.2 mm working channel, and will be used to generate a local injury on the upper posterior endometrium (Endometrial Snip) at midline 10-15 mm from the fundus on D4 to D7 of the ongoing menstrual cycle. The depth and width of the injured site will be about 2x2 mm (i.e a single bite of the claw forceps). No premedications, antibiotics or hemostatics will be given after the procedure.
Natural cycle folliculometry + timed sexual intercourse will be offered for all participants for the ongoing and the immediate subsequent cycles. Once the leading ovarian follicle will reach a size of at least 16 mm, 10,000 IU of hCG will be administered to trigger ovulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial injury | Experimental | Procedure: Endometrial injuryHysteroscopic-guided endometrial injury (Karl Storz, Tuttlingen, Germany). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 39 years old.
- Normal HSG and/or diagnostic laparoscopy.
- Normal seminal profile.
- Regular ovulation confirmed by mid-luteal progesterone.
- Normal TVS criteria.
Key exclusion criteria (4 listed)
- Uterine fibroid.
- Pelvic endometriosis.
- Irregular menstruation.
- Ovarian cysts.
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 injuryOffice hysteroscopy (Karl Storz, Tuttlingen, Germany) | Procedure or surgery | Endometrial injury |
Primary outcome
Clinical pregnancy rates (PR)
Time frame: Three consecutive months
1 secondary outcome
Miscarriage rates
Time frame: Three consecutive months
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 14 Dec 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.
Tarek Shokeir, M.D. principal investigator
Mansoura University Hospital, Mansoura Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial injury in people with Unexplained Infertility, run by Mansoura Integrated Fertility Center.
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 4 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 14 Dec 2015. 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.
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?
Clinical pregnancy rates (PR) (time frame: Three consecutive months). 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 14 Dec 2015.