InfertilityPhase 3NCT02762097
Clinical Pregnancy Rate After Removal of Unsuspected Polyps
A Phase 3 study testing polypectomy, saline sonography and normal saline in people with Infertility, run by Karachi Medical and Dental College.
Trial summary
Polyps are fleshy outgrowths of the inner lining of the womb which may hinder implantation of embryo and lead to subfertility.This study evaluates whether removal of endometrial polyps in womb affects chances of pregnancy in women in whom no other causes of subfertility can be found. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- polypectomy, saline sonography and normal saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2017to 30 Jan 2020
- Phase
- Phase 3
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Normal semen analysis
- 24 months of unprotected sexual intercourse
- NORMAL TVS
- Normal hysterosalpingogram
- Evidence of spontaneous ovulation
- No history of Pelvic inflammatory disease
- Polyps on saline sonography
Who cannot join
- History of taking hormones
- Thyroid disorder
- prior hysteroscopy treatment
- intermenstrual blood loss.
About this study
Official title: Clinical Pregnancy Rate in Women With Unexplained Infertility After Removal of Unsuspected Intrauterine Pathology
Polyps are fleshy outgrowths of the inner lining of the womb which may hinder implantation of embryo and lead to subfertility.This study evaluates whether removal of endometrial polyps in womb affects chances of pregnancy in women in whom no other causes of subfertility can be found. Half of the women would have these polyps removed after their consent and the other half who would not consent would not undergo any such intervention
- Conditions
- Infertility
- Being tested
- polypectomy, saline sonography, normal saline
- Keywords
- polyps, saline sonography, infertility
- Medical subject headings
- Infertility, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polypectomyProcedure or surgery
. During the second visit after she consents to removal of polyp revealed on prior saline sonography, a dilatation and curettage would be performed under ultrasound guidance and after successful removal of polyp (polypectomy) saline sonography would be repeated to ensure completeness of removal.
saline sonographyProcedure or surgery
saline infusion sonography (SIS) on 8th to 11th day of menstrual cycle. On the day of admission SIS will be performed in an outpatient setting .Taking all aseptic measures a speculum will be inserted vaginally and up to 20 ml of sterile saline solution will be infused into the uterine cavity through a cervical foley's catheter of 5 french to distend the endometrial cavity. A transvaginal transducer will be used to scan the uterine cavity. In case the patient has polyps she would be offered removal under general anaesthesia on a subsequent visit as a day case procedure.
normal salineDrug
Normal saline would be injected into uterine cavity to delineate defects
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | All women would undergo saline sonography with normal saline. Women with endometrial polyps who consent to the removal of polyps will be offered polypectomy Receives: Procedure: polypectomy; Procedure: saline sonography; Drug: normal saline |
| control | Placebo comparator | All women would undergo saline sonography with normal saline. Women with endometrial polyps who do not consent to the removal would serve as controls Receives: Procedure: saline sonography; Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate:
number of women who get pregnancy test positive within 12 months of intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study start30 Jan 2017 (estimated)
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Jan 2020 (estimated)
Why it stopped: Study stopped due to similar case control study already completed
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karachi Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samia husain, Karachi Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762097
- Sponsor's protocol ID
- karachiMDC
- Status last verified
- Nov 2018
- First submitted
- 30 Apr 2016
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pregnancy Rate in Women With Unexplained Infertility After Removal of Unsuspected Intrauterine Pathology
- ClinicalTrials.gov ID
- NCT02762097
- Acronym / sponsor ID
- karachiMDC
- Conditions
- Infertility
- Keywords
- polyps, saline sonography, infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped due to similar case control study already completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karachi Medical and Dental CollegeUniversity, hospital or other
- Study start
- 30 Jan 2017 (estimated)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 4 May 2016 (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.
Polyps are fleshy outgrowths of the inner lining of the womb which may hinder implantation of embryo and lead to subfertility.This study evaluates whether removal of endometrial polyps in womb affects chances of pregnancy in women in whom no other causes of subfertility can be found. Half of the women would have these polyps removed after their consent and the other half who would not consent would not undergo any such intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: polypectomy, Procedure: saline sonography, Drug: normal salineAll women would undergo saline sonography with normal saline. Women with endometrial polyps who consent to the removal of polyps will be offered polypectomy |
| control | Placebo comparator | Procedure: saline sonography, Drug: normal salineAll women would undergo saline sonography with normal saline. Women with endometrial polyps who do not consent to the removal would serve as controls |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Normal semen analysis
- 24 months of unprotected sexual intercourse
- NORMAL TVS
- Normal hysterosalpingogram
- Evidence of spontaneous ovulation
Key exclusion criteria (4 listed)
- History of taking hormones
- Thyroid disorder
- prior hysteroscopy treatment
- intermenstrual blood loss.
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 |
|---|---|---|
| polypectomy. During the second visit after she consents to removal of polyp revealed on prior saline sonography, a dilatation and curettage would be performed under ultrasound guidance and after successful removal of polyp (polypectomy) saline sonography would be repeated to ensure completeness of removal. | Procedure or surgery | intervention |
| saline sonographysaline infusion sonography (SIS) on 8th to 11th day of menstrual cycle. On the day of admission SIS will be performed in an outpatient setting .Taking all aseptic measures a speculum will be inserted vaginally and up to 20 ml of sterile saline solution will be infused into the uterine cavity through a cervical foley's catheter of 5 french to distend the endometrial cavity. A transvaginal transducer will be used to scan the uterine cavity. In case the patient has polyps she would be offered removal under general anaesthesia on a subsequent visit as a day case procedure. | Procedure or surgery | control, intervention |
| normal salineNormal saline would be injected into uterine cavity to delineate defects | Drug | control, intervention |
Primary outcome
Clinical pregnancy rate:
Time frame: 12 months
number of women who get pregnancy test positive within 12 months of intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing polypectomy, saline sonography and normal saline in people with Infertility, run by Karachi Medical and Dental College.
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 7 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: withdrawn, as of the sponsor's last update on 6 Nov 2018. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 rate: (time frame: 12 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 6 Nov 2018.