Infertility, FemaleNCT04179253
Detection of the Uterine Abnormalities Missed in an Ultrasound Scan and/or Hysterosalpingography Using Hysteroscopy, in Females Presenting With Unexplained Infertility
A study testing office micro hysteroscopy in people with Infertility, Female, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Hysteroscopy is still considered the gold standard procedure for uterine cavity exploration. Therefore, many specialists have used hysteroscopy as their first-line of routine exam for infertility patients regardless of guidelines. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- office micro hysteroscopy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Apr 2018to 14 Apr 2019
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Normal HSG
- Normal Ultrasound
- Normal Hormonal Profile
- Normal Semen
Who cannot join
- Abnormal findings in different investigations of infertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hysteroscopic Evaluation of Uterine Cavity in Women With Unexplained Infertility
Hysteroscopy is still considered the gold standard procedure for uterine cavity exploration. Therefore, many specialists have used hysteroscopy as their first-line of routine exam for infertility patients regardless of guidelines. Thus, scheduling the office micro hysteroscopy as one of the routine steps in the fertility workup program has become mandatory before the final diagnosis of unexplained infertility.
Read the detailed description
Although hysteroscopy is generally accepted as the gold standard in diagnosis and treatment of uterine cavity pathology, many gynecologist are reluctant to perform hysteroscopy as an initial test without a high degree of suspicion for pathology due to the need for anesthesia in an operating room setting. The basic infertility work-up has included a HSG to evaluate the uterine cavity and tubal patency. However, HSG does not allow for simultaneous correction of uterine pathology. Moreover HSG may miss 35% of uterine abnormalities. Hysterolaparoscopy (Pan Endoscopic) approach is better than HSG and should be encouraged as first and final procedure in selected infertile women.
Sonohysterography (SHG) has been proposed as a better diagnostic test of the uterine cavity. However, it also suffers from a sensitivity and specificity inferior to that of hysteroscopy in most studies.
- Conditions
- Infertility, Female
- Being tested
- office micro hysteroscopy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
office micro hysteroscopyDiagnostic test
One hundred women with unexplained infertility recruited for office micro hysteroscopic sessions. A rigid fiberoptic 2-mm, 0 and 30 degrees angled hysteroscopy along with an operative channel for grasping forceps or scissors were used for both diagnostic and operative indications. The findings, complications, and patient tolerance were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Unexplained infertility | Other | The patient was placed in the dorsal lithotomy position. Normal saline was used for uterine distension connected to the inflow channel on the sheath with intravenous tubing. The tip of the hysteroscope was positioned in the vaginal introitus, the labia being slightly separated with fingers. The vagina was distended with saline.
The uterine cavity was systematically explored by rotating the fore-oblique scope in order to identify any anomaly in the uterine walls and/or the right and left tubal ostia. At this stage it was crucially important to avoid lateral movements as much as possible to reduce patient discomfort to a minimum. After that, the scope was removed Finally the evaluation and the data that had been found were written in details by the surgeon. Operative intervention was done if needed. Any complication in the form of pain, bleeding, vasovagal attack and perforation, were registered in the patient sheet. Receives: Diagnostic Test: office micro hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal hysteroscopic findings
Description of different hysteroscopic abnormalities using micro-office hysteroscope
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start14 Apr 2018
- Primary completion14 Apr 2019
- Study completion14 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One hundred women with unexplained infertility recruited for office micro hysteroscopic session
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179253
- Sponsor's protocol ID
- Beni-Suef 19
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2019
- Last updated
- 27 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cooper NA, Smith P, Khan KS, Clark TJ. A systematic review of the effect of the distension medium on pain during outpatient hysteroscopy. Fertil Steril. 2011 Jan;95(1):264-71. doi: 10.1016/j.fertnstert.2010.04.080. Epub 2010 Jun 23.
PubMed 20576262Molinas CR, Campo R. Office hysteroscopy and adenomyosis. Best Pract Res Clin Obstet Gynaecol. 2006 Aug;20(4):557-67. doi: 10.1016/j.bpobgyn.2006.01.019. Epub 2006 Mar 22.
PubMed 16554185Vaid K, Mehra S, Verma M, Jain S, Sharma A, Bhaskaran S. Pan endoscopic approach "hysterolaparoscopy" as an initial procedure in selected infertile women. J Clin Diagn Res. 2014 Feb;8(2):95-8. doi: 10.7860/JCDR/2014/7271.4018. Epub 2014 Feb 3.
PubMed 24701493Kowalczyk D, Guzikowski W, Wiecek J, Sioma-Markowska U. Clinical value of real time 3D sonohysterography and 2D sonohysterography in comparison to hysteroscopy with subsequent histopathological examination in perimenopausal women with abnormal uterine bleeding. Neuro Endocrinol Lett. 2012;33(2):212-6.
PubMed 22592204
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopic Evaluation of Uterine Cavity in Women With Unexplained Infertility
- ClinicalTrials.gov ID
- NCT04179253
- Acronym / sponsor ID
- Beni-Suef 19
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 14 Apr 2018 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 27 Nov 2019 (actual)
- 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.
Hysteroscopy is still considered the gold standard procedure for uterine cavity exploration. Therefore, many specialists have used hysteroscopy as their first-line of routine exam for infertility patients regardless of guidelines. Thus, scheduling the office micro hysteroscopy as one of the routine steps in the fertility workup program has become mandatory before the final diagnosis of unexplained infertility.
Detailed description
Although hysteroscopy is generally accepted as the gold standard in diagnosis and treatment of uterine cavity pathology, many gynecologist are reluctant to perform hysteroscopy as an initial test without a high degree of suspicion for pathology due to the need for anesthesia in an operating room setting. The basic infertility work-up has included a HSG to evaluate the uterine cavity and tubal patency. However, HSG does not allow for simultaneous correction of uterine pathology. Moreover HSG may miss 35% of uterine abnormalities. Hysterolaparoscopy (Pan Endoscopic) approach is better than HSG and should be encouraged as first and final procedure in selected infertile women.
Sonohysterography (SHG) has been proposed as a better diagnostic test of the uterine cavity. However, it also suffers from a sensitivity and specificity inferior to that of hysteroscopy in most studies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One hundred women with unexplained infertility recruited for office micro hysteroscopic session
| Arm | Type | Receives |
|---|---|---|
| Unexplained infertility | Other | Diagnostic Test: office micro hysteroscopyThe patient was placed in the dorsal lithotomy position. Normal saline was used for uterine distension connected to the inflow channel on the sheath with intravenous tubing. The tip of the hysteroscope was positioned in the vaginal introitus, the labia being slightly separated with fingers. The vagina was distended with saline. The uterine cavity was systematically explored by rotating the fore-oblique scope in order to identify any anomaly in the uterine walls and/or the right and left tubal ostia. At this stage it was crucially important to avoid lateral movements as much as possible to reduce patient discomfort to a minimum. After that, the scope was removed Finally the evaluation and the data that had been found were written in details by the surgeon. Operative intervention was done if needed. Any complication in the form of pain, bleeding, vasovagal attack and perforation, were registered in the patient sheet. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Normal HSG
- Normal Ultrasound
- Normal Hormonal Profile
- Normal Semen
Key exclusion criteria (1 listed)
- Abnormal findings in different investigations of 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 |
|---|---|---|
| office micro hysteroscopyOne hundred women with unexplained infertility recruited for office micro hysteroscopic sessions. A rigid fiberoptic 2-mm, 0 and 30 degrees angled hysteroscopy along with an operative channel for grasping forceps or scissors were used for both diagnostic and operative indications. The findings, complications, and patient tolerance were recorded. | Diagnostic test | Unexplained infertility |
Primary outcome
Abnormal hysteroscopic findings
Time frame: one year
Description of different hysteroscopic abnormalities using micro-office hysteroscope
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 27 Nov 2019.
- Background: PubMed 20576262Cooper NA, Smith P, Khan KS, Clark TJ. A systematic review of the effect of the distension medium on pain during outpatient hysteroscopy. Fertil Steril. 2011 Jan;95(1):264-71. doi: 10.1016/j.fertnstert.2010.04.080. Epub 2010 Jun 23.
- Background: PubMed 16554185Molinas CR, Campo R. Office hysteroscopy and adenomyosis. Best Pract Res Clin Obstet Gynaecol. 2006 Aug;20(4):557-67. doi: 10.1016/j.bpobgyn.2006.01.019. Epub 2006 Mar 22.
- Background: PubMed 24701493Vaid K, Mehra S, Verma M, Jain S, Sharma A, Bhaskaran S. Pan endoscopic approach "hysterolaparoscopy" as an initial procedure in selected infertile women. J Clin Diagn Res. 2014 Feb;8(2):95-8. doi: 10.7860/JCDR/2014/7271.4018. Epub 2014 Feb 3.
- Background: PubMed 22592204Kowalczyk D, Guzikowski W, Wiecek J, Sioma-Markowska U. Clinical value of real time 3D sonohysterography and 2D sonohysterography in comparison to hysteroscopy with subsequent histopathological examination in perimenopausal women with abnormal uterine bleeding. Neuro Endocrinol Lett. 2012;33(2):212-6.
- Individual participant dataSharing planned: No
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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 study testing office micro hysteroscopy in people with Infertility, Female, run by Beni-Suef University at 1 site in Egypt.
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 4 inclusion and 1 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 27 Nov 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 Egypt. 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 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?
Abnormal hysteroscopic findings (time frame: one year). 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 NCT04179253, which also lists 4 linked publications.
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 27 Nov 2019.