Tubal Factor InfertilityNCT03476759
Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI
A study testing Tubal adhesiolysis and IVF/ICSI in people with Tubal Factor Infertility, run by Tanta University at 1 site in Egypt.
Trial summary
2groups with peritoneal adhesions after cesarean delivery will be allocated to either laparoscopic tubal adhesiolysis or to IVF/ICSI Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Tubal Factor Infertility
- What is being tested?
- Tubal adhesiolysis and IVF/ICSI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 31 Oct 2021
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age not exceeding 35 years old with confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video CDs) as a solitary cause of their 2ry infertility.
Who cannot join
- patient's age >35 years, male factor contribution, any ovulatory or endocrinological disorder, diagnosed any degree of endometriosis and patients with history of recurrent pregnancy loss. Couples with prolonged sexual abstinence for any reason will be excluded from participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI in Cases of Post Caesarean Section Adhesions, Which is the Best?
2groups with peritoneal adhesions after cesarean delivery will be allocated to either laparoscopic tubal adhesiolysis or to IVF/ICSI
Read the detailed description
This randomized clinical trial will be conducted at Tanta university hospitals in fertility and MIS units. Two hundred and fifty 2ry infertility patients with confirmed post C.S adhesions will be included in the study and those patients will be divided randomly in two groups:
Group A:
125 patients will be undergoing laparoscopic tubal adhesiolysis and\or tuboplasty then a widow of 12 months post operatively is given for natural conception.
Group B:
125 patients will undergo IVF-ICSI procedures. The primary outcome measure of the study will be the rate of clinical pregnancy.
Inclusion criteria:
- patient's age not exceeding 35 years old
- confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video CDs) as a solitary cause of their 2ry infertility.
Exclusion criteria:
- patient's age >35 years
- other causes of infertility as male factor contribution, any ovulatory or endocrinological disorder,
- diagnosed any degree of endometriosis
- patients with history of recurrent pregnancy loss.
- couples with prolonged sexual abstinence for any reason Detailed explanation of the aims, procedures, steps and nature of the study for the participants will be done and a written consent will be signed by each patient before inclusion.
After allocation laparoscopic tubal adhesions will be dissected and normal anatomy and function will be restored. In the other group IVF/ICSI will be commenced The follow up with both groups will extend to 1year or till pregnancy is aggrieved The outcomes of the study were pregnancy rates and affordability
- Conditions
- Tubal Factor Infertility
- Being tested
- Tubal adhesiolysis, IVF/ICSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubal adhesiolysisProcedure or surgery
125 patients will undergo tubal adhesiolysis or tuboplasty
IVF/ICSIDrug
125 patients will undergo IVF-ICSI procedures.
| Study group | Role | What they receive |
|---|---|---|
| Tubal adhesiolysis | Active comparator | laparoscopic tubal adhesiolysis and\or tuboplasty Receives: Procedure: Tubal adhesiolysis |
| IVF/ICSI | Active comparator | These patients will undergo IVF/ICSI Receives: Drug: IVF/ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
The number of pregnant women in both groups
Measured: After 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 May 2018
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubal Factor InfertilityStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
- Investigators
- Ayman Dawood, MD, Principal investigator, Lecturer at Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476759
- Sponsor's protocol ID
- Tanta University
- Status last verified
- Nov 2021
- First submitted
- 18 Mar 2018
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI in Cases of Post Caesarean Section Adhesions, Which is the Best?
- ClinicalTrials.gov ID
- NCT03476759
- Acronym / sponsor ID
- Tanta University
- Conditions
- Tubal Factor Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 26 Mar 2018 (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.
2groups with peritoneal adhesions after cesarean delivery will be allocated to either laparoscopic tubal adhesiolysis or to IVF/ICSI
Detailed description
This randomized clinical trial will be conducted at Tanta university hospitals in fertility and MIS units. Two hundred and fifty 2ry infertility patients with confirmed post C.S adhesions will be included in the study and those patients will be divided randomly in two groups:
Group A:
125 patients will be undergoing laparoscopic tubal adhesiolysis and\or tuboplasty then a widow of 12 months post operatively is given for natural conception.
Group B:
125 patients will undergo IVF-ICSI procedures. The primary outcome measure of the study will be the rate of clinical pregnancy.
Inclusion criteria:
- patient's age not exceeding 35 years old
- confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video CDs) as a solitary cause of their 2ry infertility.
Exclusion criteria:
- patient's age >35 years
- other causes of infertility as male factor contribution, any ovulatory or endocrinological disorder,
- diagnosed any degree of endometriosis
- patients with history of recurrent pregnancy loss.
- couples with prolonged sexual abstinence for any reason Detailed explanation of the aims, procedures, steps and nature of the study for the participants will be done and a written consent will be signed by each patient before inclusion.
After allocation laparoscopic tubal adhesions will be dissected and normal anatomy and function will be restored. In the other group IVF/ICSI will be commenced The follow up with both groups will extend to 1year or till pregnancy is aggrieved The outcomes of the study were pregnancy rates and affordability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tubal adhesiolysis | Active comparator | Procedure: Tubal adhesiolysislaparoscopic tubal adhesiolysis and\or tuboplasty |
| IVF/ICSI | Active comparator | Drug: IVF/ICSIThese patients will undergo IVF/ICSI |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age not exceeding 35 years old with confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video CDs) as a solitary cause of their 2ry infertility.
Key exclusion criteria (1 listed)
- patient's age >35 years, male factor contribution, any ovulatory or endocrinological disorder, diagnosed any degree of endometriosis and patients with history of recurrent pregnancy loss. Couples with prolonged sexual abstinence for any reason will be excluded from participation in the study.
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 |
|---|---|---|
| Tubal adhesiolysis125 patients will undergo tubal adhesiolysis or tuboplasty | Procedure or surgery | Tubal adhesiolysis |
| IVF/ICSI125 patients will undergo IVF-ICSI procedures. | Drug | IVF/ICSI |
Primary outcome
clinical pregnancy rate
Time frame: After 1year
The number of pregnant women in both groups
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 29 Nov 2021.
- Individual participant dataSharing planned: Undecided. yes
Related trials for Tubal Factor Infertility
Recruiting
Comprehensive Assessment System for Fallopian Tube Function and Clinical Study on Individualized Treatment Strategies
Multidimensional Tubal Function Assessment and Individualized Treatment Strategies for Tubal Factor Infertility
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.
Ayman Dawood, MD principal investigator
Lecturer at Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tubal adhesiolysis and IVF/ICSI in people with Tubal Factor Infertility, run by Tanta 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 1 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 29 Nov 2021. 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?
clinical pregnancy rate (time frame: After 1year). 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 29 Nov 2021.