Ectopic PregnancyNCT02714998
The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy
A study testing Methotrexate and salpingectomy in people with Ectopic Pregnancy and Infertility, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to investigate the effects of salpingectomy and Methotrexate administration on ovarian reserve in ectopic pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ectopic Pregnancy, Infertility
- What is being tested?
- Methotrexate and salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Feb 2015
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ectopic pregnancy diagnosis
Who cannot join
- history of endometriosis, ovarian surgery, systemic chemotherapy, ART treatment.
- patients treated with multiple doses of methotrexate or different surgical procedure (salpingostomy, milking)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Medicine Department of Obstetrics and Gynecology
Izmir, 35100
About this study
The investigators aimed to investigate the effects of salpingectomy and Methotrexate administration on ovarian reserve in ectopic pregnancy.
Read the detailed description
In this study, the effects of unilateral laparoscopic salpingectomy and single dose of systemic Methotrexate administration on ovarian reserve in patients diagnosed with ectopic pregnancy were investigated.
- Conditions
- Ectopic Pregnancy, Infertility
- Being tested
- Methotrexate, salpingectomy
- Keywords
- ectopic pregnancy, ovarian reserve, salpingectomy, methotrexate
- Medical subject headings
- Pregnancy, Ectopic, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Mtx
single dose systemic methotrexate administration (50 mg/m2)
salpingectomyProcedure or surgery
Laparoscopic unilateral salpingectomy
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate only | Active comparator | Single dose of systemic Methotrexate administered to 55 patients. Receives: Drug: Methotrexate |
| Salpingectomy only group | Active comparator | Laparoscopic unilateral salpingectomy performed to 61 patients. Receives: Procedure: salpingectomy |
| Salpingectomy following Methotrexate | Active comparator | 15 patients underwent laparoscopic unilateral salpingectomy following unsuccessful single dose of methotrexate administration. Receives: Drug: Methotrexate; Procedure: salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve assessment by measuring AMH level.
Ovarian reserve were assessed before and after treatment by measuring AMH levels.
Measured: 1-3 months
Secondary outcomes (1)
Number of participants with treatment related adverse effect on fertility.
Rates of term delivery, spontaneous abortion, recurrent ectopic pregnancy and ongoing pregnancy for each group of patients were calculated during 2 years of follow up period.
Measured: 2 years of follow up after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startJan 2013
- Primary completionFeb 2015
- Study completionFeb 2015
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 Ege 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enes Taylan, Ege University
- Investigators
- Ahmet M. Ergenoglu, Ass. Prof., Study director, Ege University School of Medicine Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714998
- Sponsor's protocol ID
- 2013-TIP-043
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: The investigators have not decided to share patient data yet. However, it is possible if approved by ethical committee.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT02714998
- Acronym / sponsor ID
- 2013-TIP-043
- Conditions
- Ectopic Pregnancy, Infertility
- Keywords
- ectopic pregnancy, ovarian reserve, salpingectomy, methotrexate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Mar 2016 (estimated)
- 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.
The investigators aimed to investigate the effects of salpingectomy and Methotrexate administration on ovarian reserve in ectopic pregnancy.
Detailed description
In this study, the effects of unilateral laparoscopic salpingectomy and single dose of systemic Methotrexate administration on ovarian reserve in patients diagnosed with ectopic pregnancy were investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methotrexate only | Active comparator | Drug: MethotrexateSingle dose of systemic Methotrexate administered to 55 patients. |
| Salpingectomy only group | Active comparator | Procedure: salpingectomyLaparoscopic unilateral salpingectomy performed to 61 patients. |
| Salpingectomy following Methotrexate | Active comparator | Drug: Methotrexate, Procedure: salpingectomy15 patients underwent laparoscopic unilateral salpingectomy following unsuccessful single dose of methotrexate administration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ectopic pregnancy diagnosis
Key exclusion criteria (2 listed)
- history of endometriosis, ovarian surgery, systemic chemotherapy, ART treatment.
- patients treated with multiple doses of methotrexate or different surgical procedure (salpingostomy, milking)
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 |
|---|---|---|
| MethotrexateAlso: Mtxsingle dose systemic methotrexate administration (50 mg/m2) | Drug | Methotrexate only, Salpingectomy following Methotrexate |
| salpingectomyLaparoscopic unilateral salpingectomy | Procedure or surgery | Salpingectomy following Methotrexate, Salpingectomy only group |
Primary outcome
Ovarian reserve assessment by measuring AMH level.
Time frame: 1-3 months
Ovarian reserve were assessed before and after treatment by measuring AMH levels.
1 secondary outcome
Number of participants with treatment related adverse effect on fertility.
Time frame: 2 years of follow up after treatment
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 22 Mar 2016.
- Individual participant dataSharing planned: Undecided. The investigators have not decided to share patient data yet. However, it is possible if approved by ethical committee.
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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.
Ahmet M. Ergenoglu, Ass. Prof. study director
Ege University School of Medicine Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate and salpingectomy in people with Ectopic Pregnancy and Infertility, run by Ege University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 22 Mar 2016. 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 Turkey (Türkiye). 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?
Ovarian reserve assessment by measuring AMH level. (time frame: 1-3 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 22 Mar 2016.