Hystrolaparoscopic Findings in Infertile Women With Previous Uterine SurgeriesNCT06759220
Hystrolaparoscopic Findings in Infertile Women With Previous Uterine Surgery
An observational study of Hystrolaparoscopic Findings in Infertile Women With Previous Uterine Surgeries, run by Assiut University at 1 site in Egypt.
Trial summary
1. to determine the rate and pattern of abnormal laparoscopic finding among the infertile women with history of previous uterine surgery. 2. To detemine the rate and pattern of abnormal hysteroscopic finding among infertile women with with history of previous uterine sergery 3. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Hystrolaparoscopic Findings in Infertile Women With Previous Uterine Surgeries
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2025to 21 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile women between age of 20to 35yr with previous uterine surgeries
Who may be able to join
- All women between20 to 35 yrs old with secondary infertiliy for 2 years
- Women with previous uterine surgery
Who cannot join
- Female with major medical illness(Uncontrolled daibetes, cardiac diseases, uncontrolled thyroid disorders)
- Abnormal semen parameter of the husband.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Hystrolaparosciopic Findings in Infertile Women With Secondary Infertility
- to determine the rate and pattern of abnormal laparoscopic finding among the infertile women with history of previous uterine surgery.
- To detemine the rate and pattern of abnormal hysteroscopic finding among infertile women with with history of previous uterine sergery
- to evaluate the value of doing combined laparoscopy and hysteroscopy in infertile women with with history of previous uterine surgery.
- To determine possible risk factors of pelvic adhesions detected during laparoscopy.
- To determine possible risk factors causing cs niche.
Read the detailed description
nfertility(1), which refers to the inability of a couple to conceive after one year of regular unprotected sexual intercourse, is the commonest indication for gynacological consultation. primary infertility - where someone who's never conceived a child in the past. secondary infertility(2) - where someone has had 1 or more pregnancies in the past, but is having difficulty conceiving again.there are many causes for infertility. (3)uterine causes as uterine fibroids or malformations.tubal factors as tuboperitoneal adhesions,unilateral or bilateral proximal occlusion unilateral or bilateral hydrosalpinx or pyosalpinx.Ovarian factors ovarian cyst,polycystic ovaries.pelvic causes as adhesions ,endometriosis and miscellaneous. laparoscopy can be used as the gold standard diagnostic tool which allows direct visualization of all pelvic organs. It also helps in detailed assessment of fallopian tubes. The advantage behind using laparoscopy is that the treatment of certain conditions such as tubal obstruction, endometriosis, and pelvic adhesions can be done at the same time during diagnosis. If needed, laparoscopic chromopertubation can also be done for tubal patency during the same sitting. (4)Hysteroscopy is the direct visualization of the uterine cavity using an endoscope. Uterine cavity evaluation is very much needed to do achieve total infertility workup. Uterine abnormalities are present among 10-15% of couples who seek treatment of infertility. For evaluation of endometrial factors,(5) hysteroscopy considered to be a gold standard. Diagnostic h hysteroscopy can detect uterine anomalies which remain undetected in USG and other routine investigations.
Many studies reported the occurrence of pelvic adhesions following cesarean section with its related consequences.
pelvic adhesions may affect both reproductive system anatomy and function, causing various associated conditions. Pelvic adhesions may cause secondary infertility, which might be due to dyspareunia, disturbing tubo-ovarian relationship, or disturbing peristaltic movement of fallopian tube.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary (main): rate and pattern of abnormal laparoscopic and hysteroscopic findings in infertile women with previous uterine surgery
Primary (main): rate and pattern of abnormal laparoscopic and hysteroscopic findings in infertile women with previous uterine surgery
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start21 Sep 2025 (estimated)
- Primary completion21 Mar 2027 (estimated)
- Study completion21 Sep 2028 (estimated)
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 Hystrolaparoscopic Findings in Infertile Women With Previous Uterine SurgeriesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Ali Ramadan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759220
- Sponsor's protocol ID
- Laparoscopy in infertility
- Status last verified
- Sep 2024
- First submitted
- 30 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ibekwe PC, Udensi AM, Imo AO. Hysterosalpingographic findings in patients with infertility in South eastern Nigeria. Niger J Med. 2010 Apr-Jun;19(2):165-7. doi: 10.4314/njm.v19i2.56510.
PubMed 20642082Bukar M, Mustapha Z, Takai UI, Tahir A. Hysterosalpingographic findings in infertile women: a seven year review. Niger J Clin Pract. 2011 Apr-Jun;14(2):168-70. doi: 10.4103/1119-3077.84008.
PubMed 21860133Bello TO. Tubal abnormalities on hysterosalpingography in primary and secondary infertility. West Afr J Med. 2006 Apr-Jun;25(2):130-3. doi: 10.4314/wajm.v25i2.28263.
PubMed 16918185Adesiyun AG, Ameh CA, Eka A. Hysterosalpingographic tubal abnormalities and HIV infection among black women with tubal infertility in sub-Saharan Africa. Gynecol Obstet Invest. 2008;66(2):119-22. doi: 10.1159/000128600. Epub 2008 Apr 29.
PubMed 18446041
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hystrolaparosciopic Findings in Infertile Women With Secondary Infertility
- ClinicalTrials.gov ID
- NCT06759220
- Acronym / sponsor ID
- Laparoscopy in infertility
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 21 Sep 2025 (estimated)
- Primary completion
- 21 Mar 2027 (estimated)
- Study completion
- 21 Sep 2028 (estimated)
- First posted
- 6 Jan 2025 (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.
- to determine the rate and pattern of abnormal laparoscopic finding among the infertile women with history of previous uterine surgery.
- To detemine the rate and pattern of abnormal hysteroscopic finding among infertile women with with history of previous uterine sergery
- to evaluate the value of doing combined laparoscopy and hysteroscopy in infertile women with with history of previous uterine surgery.
- To determine possible risk factors of pelvic adhesions detected during laparoscopy.
- To determine possible risk factors causing cs niche.
Detailed description
nfertility(1), which refers to the inability of a couple to conceive after one year of regular unprotected sexual intercourse, is the commonest indication for gynacological consultation. primary infertility - where someone who's never conceived a child in the past. secondary infertility(2) - where someone has had 1 or more pregnancies in the past, but is having difficulty conceiving again.there are many causes for infertility. (3)uterine causes as uterine fibroids or malformations.tubal factors as tuboperitoneal adhesions,unilateral or bilateral proximal occlusion unilateral or bilateral hydrosalpinx or pyosalpinx.Ovarian factors ovarian cyst,polycystic ovaries.pelvic causes as adhesions ,endometriosis and miscellaneous. laparoscopy can be used as the gold standard diagnostic tool which allows direct visualization of all pelvic organs. It also helps in detailed assessment of fallopian tubes. The advantage behind using laparoscopy is that the treatment of certain conditions such as tubal obstruction, endometriosis, and pelvic adhesions can be done at the same time during diagnosis. If needed, laparoscopic chromopertubation can also be done for tubal patency during the same sitting. (4)Hysteroscopy is the direct visualization of the uterine cavity using an endoscope. Uterine cavity evaluation is very much needed to do achieve total infertility workup. Uterine abnormalities are present among 10-15% of couples who seek treatment of infertility. For evaluation of endometrial factors,(5) hysteroscopy considered to be a gold standard. Diagnostic h hysteroscopy can detect uterine anomalies which remain undetected in USG and other routine investigations.
Many studies reported the occurrence of pelvic adhesions following cesarean section with its related consequences.
pelvic adhesions may affect both reproductive system anatomy and function, causing various associated conditions. Pelvic adhesions may cause secondary infertility, which might be due to dyspareunia, disturbing tubo-ovarian relationship, or disturbing peristaltic movement of fallopian tube.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women between age of 20to 35yr with previous uterine surgeries
Key inclusion criteria (2 listed)
- All women between20 to 35 yrs old with secondary infertiliy for 2 years
- Women with previous uterine surgery
Key exclusion criteria (2 listed)
- Female with major medical illness(Uncontrolled daibetes, cardiac diseases, uncontrolled thyroid disorders)
- Abnormal semen parameter of the husband.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary (main): rate and pattern of abnormal laparoscopic and hysteroscopic findings in infertile women with previous uterine surgery
Time frame: Baseline
Primary (main): rate and pattern of abnormal laparoscopic and hysteroscopic findings in infertile women with previous uterine surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Results publication: PubMed 20642082Ibekwe PC, Udensi AM, Imo AO. Hysterosalpingographic findings in patients with infertility in South eastern Nigeria. Niger J Med. 2010 Apr-Jun;19(2):165-7. doi: 10.4314/njm.v19i2.56510.
- Results publication: PubMed 21860133Bukar M, Mustapha Z, Takai UI, Tahir A. Hysterosalpingographic findings in infertile women: a seven year review. Niger J Clin Pract. 2011 Apr-Jun;14(2):168-70. doi: 10.4103/1119-3077.84008.
- Results publication: PubMed 16918185Bello TO. Tubal abnormalities on hysterosalpingography in primary and secondary infertility. West Afr J Med. 2006 Apr-Jun;25(2):130-3. doi: 10.4314/wajm.v25i2.28263.
- Results publication: PubMed 18446041Adesiyun AG, Ameh CA, Eka A. Hysterosalpingographic tubal abnormalities and HIV infection among black women with tubal infertility in sub-Saharan Africa. Gynecol Obstet Invest. 2008;66(2):119-22. doi: 10.1159/000128600. Epub 2008 Apr 29.
- Individual participant dataSharing planned: No
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.
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 Hystrolaparoscopic Findings in Infertile Women With Previous Uterine Surgeries, 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 2 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: opening soon, as of the sponsor's last update on 6 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia Ali, Master (01065206186, daliaheaven@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (main): rate and pattern of abnormal laparoscopic and hysteroscopic findings in infertile women with previous uterine surgery (time frame: Baseline). 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 NCT06759220, 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 6 Jan 2025.