Pregnancy RateNCT04389203
Pregnancy Rate After Unilateral Tubal Disconnection
A study testing Unilateral tubal disconnection + Spontaneous follow up for pregnancy and Unilateral tubal disconnection + ICSI in people with Pregnancy Rate, run by Tanta University at 1 site in Egypt.
Trial summary
Unilateral disconnection of one tube that had hydrosalpinx Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pregnancy Rate
- What is being tested?
- Unilateral tubal disconnection + Spontaneous follow up for pregnancy and Unilateral tubal disconnection + ICSI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 30 Jun 2024
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertile women either primary or secondary Hydrosalpinx
Who cannot join
- other factors of infertility
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Adel Elgergawy
Tanta, Gharbia Governorate, 31111
Adel Elgergawy, MD, +201002057250, dradelali775@gmail.com
About this study
Official title: Pregnancy Rate After Laparoscopic Unilateral Tubal Disconnection
Unilateral disconnection of one tube that had hydrosalpinx
Read the detailed description
In cases suffering from infertility and all other factors were normal except hysterosalpingogram that showed hydrosalpinx.
We either did intracytoplasmic sperm injection (ICSI) in one group and spontaneous follow up for 2 years after laparoscopy Pregnancy rate in both groups was assessed
- Conditions
- Pregnancy Rate
- Being tested
- Unilateral tubal disconnection + Spontaneous follow up for pregnancy, Unilateral tubal disconnection + ICSI
- Keywords
- pregnancy rate, Lasparosocpy, Unilateral tubal disconnection, Intracytoplasmic sperm injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral tubal disconnection + Spontaneous follow up for pregnancyProcedure or surgery
Unilateral tubal disconnection + Spontaneous follow up for pregnancy
Unilateral tubal disconnection + ICSIProcedure or surgery
Unilateral tubal disconnection + ICSI
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Unilateral tubal disconnection and waiting for pregnancy for 2 years after laparoscopy Receives: Procedure: Unilateral tubal disconnection + Spontaneous follow up for pregnancy |
| Control group | Experimental | Unilateral tubal disconnection and ICSI Receives: Procedure: Unilateral tubal disconnection + ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Number of pregnant women after procedure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RateStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unilateral tubal disconnection and spontaneous pregnancy
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389203
- Sponsor's protocol ID
- PRAUTD
- Status last verified
- Nov 2023
- First submitted
- 12 May 2020
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When we finish the results
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Rate After Laparoscopic Unilateral Tubal Disconnection
- ClinicalTrials.gov ID
- NCT04389203
- Acronym / sponsor ID
- PRAUTD
- Conditions
- Pregnancy Rate
- Keywords
- pregnancy rate, Lasparosocpy, Unilateral tubal disconnection, Intracytoplasmic sperm injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 15 May 2020 (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.
Unilateral disconnection of one tube that had hydrosalpinx
Detailed description
In cases suffering from infertility and all other factors were normal except hysterosalpingogram that showed hydrosalpinx.
We either did intracytoplasmic sperm injection (ICSI) in one group and spontaneous follow up for 2 years after laparoscopy Pregnancy rate in both groups was assessed
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unilateral tubal disconnection and spontaneous pregnancy
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Unilateral tubal disconnection + Spontaneous follow up for pregnancyUnilateral tubal disconnection and waiting for pregnancy for 2 years after laparoscopy |
| Control group | Experimental | Procedure: Unilateral tubal disconnection + ICSIUnilateral tubal disconnection and ICSI |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- infertile women either primary or secondary Hydrosalpinx
Key exclusion criteria (1 listed)
- other factors 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 |
|---|---|---|
| Unilateral tubal disconnection + Spontaneous follow up for pregnancyUnilateral tubal disconnection + Spontaneous follow up for pregnancy | Procedure or surgery | Study group |
| Unilateral tubal disconnection + ICSIUnilateral tubal disconnection + ICSI | Procedure or surgery | Control group |
Primary outcome
Pregnancy rate
Time frame: 2 years
Number of pregnant women after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: Yes. When we finish the results
Related trials for Pregnancy Rate
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral tubal disconnection + Spontaneous follow up for pregnancy and Unilateral tubal disconnection + ICSI in people with Pregnancy Rate, 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: status not confirmed, as of the sponsor's last update on 27 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: 2 years). 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 27 Nov 2023.