Infertility, FemaleNCT03166657
Office Hysteroscopy in Secondary Infertility After Cesarean Section
An observational study of Infertility, Female, run by Assiut University at 1 site in Egypt.
Trial summary
All women with history of secondary infertility after caesarean section will be subjected to office hysteroscopy according to Royal college of obstetrics and gynecology guidelines to diagnose any subtle uterine abnormalities not detected by conventional means. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- office hysteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 1 Jun 2019
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will include all secondary infertile cases after cesarean section who presented to infertility clinic at Women health Hospital, Assiut University
Who may be able to join
- Patients with secondary infertility more than 2 years after cesarean section.
- Normal semen analysis
- Normal hysterosalpingography or laparoscopy within 1year
- Evidence of ovulation by transvaginal ultrasound
Who cannot join
- • Cases with abnormal semen parameters.
- Patients with abnormal hysterosalpingography.
- Patients with anovulation.
- Hormonal disturbances; high level of prolactin, thyroid hormone disturbances, very high or very low follicular stimulating hormone and luteinizing hormone
- Patients known to be epileptic or with history of fits.
- Cardiac patients ( valve diseases, ischemic, arrhythmic)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Office Hysteroscopy in Cases of Secondary Infertility After Cesarean Section
All women with history of secondary infertility after caesarean section will be subjected to office hysteroscopy according to Royal college of obstetrics and gynecology guidelines to diagnose any subtle uterine abnormalities not detected by conventional means.
Hysteroscopic examination will be done during the proliferation phase of the menstrual cycle.
Read more
The hysteroscopic evaluation will include assessment of the cervical canal, intrauterine lesions, the endometrium and the uterotubal junction. .
If hysteroscopy reveal a lesion, its type, size, location will be recorded. Transvaginal ultrasound will be done after the procedure to detect fluid in the douglas pouch to confirm patent tubes.
Asses the uterine scar in details.
- Conditions
- Infertility, Female
- Being tested
- office 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 hysteroscopyProcedure or surgery
A speculum is first inserted into the vagina. The hysteroscope is then inserted and gently moved through the cervix into uterus. Carbon dioxide gas or a fluid, such as saline will be put through the hysteroscope into uterus to expand it. The gas or fluid helps see the lining more clearly. The amount of fluid used is carefully checked throughout the procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with abnormal scar findings in hysteroscopy
color of the scar and presence of niche
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Mar 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Ahmad Abdelraof Ahmad Askar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166657
- Sponsor's protocol ID
- OHCS
- Status last verified
- May 2020
- First submitted
- 24 May 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boivin J, Bunting L, Collins JA, Nygren KG. International estimates of infertility prevalence and treatment-seeking: potential need and demand for infertility medical care. Hum Reprod. 2007 Jun;22(6):1506-12. doi: 10.1093/humrep/dem046. Epub 2007 Mar 21.
PubMed 17376819Collins JA, Crosignani PG. Unexplained infertility: a review of diagnosis, prognosis, treatment efficacy and management. Int J Gynaecol Obstet. 1992 Dec;39(4):267-75. doi: 10.1016/0020-7292(92)90257-j.
PubMed 1361459
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Office Hysteroscopy in Cases of Secondary Infertility After Cesarean Section
- ClinicalTrials.gov ID
- NCT03166657
- Acronym / sponsor ID
- OHCS
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 25 May 2017 (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.
All women with history of secondary infertility after caesarean section will be subjected to office hysteroscopy according to Royal college of obstetrics and gynecology guidelines to diagnose any subtle uterine abnormalities not detected by conventional means.
Hysteroscopic examination will be done during the proliferation phase of the menstrual cycle.
The hysteroscopic evaluation will include assessment of the cervical canal, intrauterine lesions, the endometrium and the uterotubal junction. .
If hysteroscopy reveal a lesion, its type, size, location will be recorded. Transvaginal ultrasound will be done after the procedure to detect fluid in the douglas pouch to confirm patent tubes.
Asses the uterine scar in details.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will include all secondary infertile cases after cesarean section who presented to infertility clinic at Women health Hospital, Assiut University
Key inclusion criteria (4 listed)
- Patients with secondary infertility more than 2 years after cesarean section.
- Normal semen analysis
- Normal hysterosalpingography or laparoscopy within 1year
- Evidence of ovulation by transvaginal ultrasound
Key exclusion criteria (6 listed)
- • Cases with abnormal semen parameters.
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 hysteroscopyA speculum is first inserted into the vagina. The hysteroscope is then inserted and gently moved through the cervix into uterus. Carbon dioxide gas or a fluid, such as saline will be put through the hysteroscope into uterus to expand it. The gas or fluid helps see the lining more clearly. The amount of fluid used is carefully checked throughout the procedure | Procedure or surgery | – |
Primary outcome
percentage of patients with abnormal scar findings in hysteroscopy
Time frame: 1 year
color of the scar and presence of niche
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 12 May 2020.
- Background: PubMed 17376819Boivin J, Bunting L, Collins JA, Nygren KG. International estimates of infertility prevalence and treatment-seeking: potential need and demand for infertility medical care. Hum Reprod. 2007 Jun;22(6):1506-12. doi: 10.1093/humrep/dem046. Epub 2007 Mar 21.
- Background: PubMed 1361459Collins JA, Crosignani PG. Unexplained infertility: a review of diagnosis, prognosis, treatment efficacy and management. Int J Gynaecol Obstet. 1992 Dec;39(4):267-75. doi: 10.1016/0020-7292(92)90257-j.
- 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?
An observational study of Infertility, Female, run by Assiut 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 6 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 12 May 2020. 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?
percentage of patients with abnormal scar findings in hysteroscopy (time frame: 1 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 NCT03166657, which also lists 2 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 12 May 2020.