Ectopic PregnancyNCT06471166
The Effect of Different Treatment Modalities of Tubal Ectopic Pregnancy on Ovarian Reserve: a Prospective Cohort Study
An observational study of Ectopic Pregnancy, run by Assiut University at 1 site in Egypt.
Trial summary
Detect the effect of different treatment modalities of tubal ectopic pregnancy on ovarian reserve Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Amh hormone
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2024to 10 Oct 2025
- 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 44 years
- Women only
- Adult
Study population: Women's Health Hospital, Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University
Who may be able to join
- The study will include patients aged 18-44 years with known diagnosis or suspicion of diagnosis of tubal ectopic pregnancy (abnormal doubling rates of their b-HCG levels as well as ultrasonographically identified or unidentified gestational sacs outside the uterus)
- Included patients must have capacity to provide informed consent. Given the potential emergent nature of presentation, women will not be recruited if fully informed consent could be compromised due to a highly distressed emotional state or significant hemorrhage necessitating the need for urgent surgery
Who cannot join
- The use of hormonal contraceptives within two months of enrolment
- If other surgery was conducted at the time of salpingectomy.
- If a woman was pregnant at follow up visit for AMH measurement
- History of previous surgeries of fallopian tubes and/or ovaries
Trial locations and contacts
1 site in 1 country.
About this study
Detect the effect of different treatment modalities of tubal ectopic pregnancy on ovarian reserve
- Conditions
- Ectopic Pregnancy
- Being tested
- Amh hormone
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amh hormoneDiagnostic test
Ovarian reserve
| Study group | Role | What they receive |
|---|---|---|
| Conservative management | Not described Receives: Diagnostic Test: Amh hormone | |
| Medical treatment | Not described Receives: Diagnostic Test: Amh hormone | |
| Surgical treatment (Open or laparoscopic salpingectomy) | Not described Receives: Diagnostic Test: Amh hormone | |
| Surgical treatment after failed medical treatment (Open or laparoscopic salpingectomy) | Not described Receives: Diagnostic Test: Amh hormone | |
| Conservative surgical treatment (salpingotomy, salpingostomy, tubal milking) | Not described Receives: Diagnostic Test: Amh hormone | |
| Conservative surgical treatment after failed medical treatment | Not described Receives: Diagnostic Test: Amh hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of AMH pre and post treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start10 Jul 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion10 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andro Bahgat Heshmat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471166
- Sponsor's protocol ID
- Ectopic pregnancy
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Treatment Modalities of Tubal Ectopic Pregnancy on Ovarian Reserve: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06471166
- Acronym / sponsor ID
- Ectopic pregnancy
- Conditions
- Ectopic Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 10 Oct 2025 (estimated)
- First posted
- 24 Jun 2024 (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.
Detect the effect of different treatment modalities of tubal ectopic pregnancy on ovarian reserve
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Conservative management | – | Diagnostic Test: Amh hormone |
| Medical treatment | – | Diagnostic Test: Amh hormone |
| Surgical treatment (Open or laparoscopic salpingectomy) | – | Diagnostic Test: Amh hormone |
| Surgical treatment after failed medical treatment (Open or laparoscopic salpingectomy) | – | Diagnostic Test: Amh hormone |
| Conservative surgical treatment (salpingotomy, salpingostomy, tubal milking) | – | Diagnostic Test: Amh hormone |
| Conservative surgical treatment after failed medical treatment | – | Diagnostic Test: Amh hormone |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women's Health Hospital, Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University
Key inclusion criteria (2 listed)
- The study will include patients aged 18-44 years with known diagnosis or suspicion of diagnosis of tubal ectopic pregnancy (abnormal doubling rates of their b-HCG levels as well as ultrasonographically identified or unidentified gestational sacs outside the uterus)
- Included patients must have capacity to provide informed consent. Given the potential emergent nature of presentation, women will not be recruited if fully informed consent could be compromised due to a highly distressed emotional state or significant hemorrhage necessitating the need for urgent surgery
Key exclusion criteria (4 listed)
- The use of hormonal contraceptives within two months of enrolment
- If other surgery was conducted at the time of salpingectomy.
- If a woman was pregnant at follow up visit for AMH measurement
- History of previous surgeries of fallopian tubes and/or ovaries
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 |
|---|---|---|
| Amh hormoneOvarian reserve | Diagnostic test | Conservative management, Conservative surgical treatment (salpingotomy, salpingostomy, tubal milking), Conservative surgical treatment after failed medical treatment, Medical treatment, Surgical treatment (Open or laparoscopic salpingectomy), Surgical treatment after failed medical treatment (Open or laparoscopic salpingectomy) |
Primary outcome
Change in levels of AMH pre and post treatment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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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.
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 Ectopic Pregnancy, 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 4 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 24 Jun 2024. 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?
Contact Andro Bahgat, MD (01283104773, androbahgat7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of AMH pre and post treatment (time frame: 3 months). 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 24 Jun 2024.