Ectopic PregnancyNCT06504082
Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy
A study testing Letrozole and Methotrexate in people with Ectopic Pregnancy, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The objective of the study is to compare the effectiveness of single-dose methotrexate and letrozole + single-dose methotrexate in treating ectopic pregnancy, focusing on treatment success, changes in ß-hCG levels, hemogram and biochemical markers, surgical intervention due to rupture, fertility preservation, and… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Ectopic Pregnancy
- What is being tested?
- Letrozole and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2021to 5 Sep 2022
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with ectopic pregnancy according to the diagnostic criteria
- Patients with β-hCG levels <5000 mIU/ml,
- Patients without serious or persistent abdominal pain
- Patients without fetal cardiac activity observed
- Ectopic mass size smaller than 3-4 cm
- Patients without contraindications for methotrexate and letrozole
Who cannot join
- Ruptured ectopic pregnancies
- Hemodynamically unstable patients
- Patients with acute abdomen or intra-abdominal bleeding
- Patients with fetal cardiac activity
- β-hCG levels below 500 mIU/mL or above 5000 mIU/mL
- Patients non-compliant with treatment
- Ectopic pregnancy size over 40 mm
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to compare the effectiveness of single-dose methotrexate and letrozole + single-dose methotrexate in treating ectopic pregnancy, focusing on treatment success, changes in ß-hCG levels, hemogram and biochemical markers, surgical intervention due to rupture, fertility preservation, and reduction of maternal morbidity, mortality, and healthcare costs. This is a prospective study conducted on 60 ectopic pregnancy patients at Van Yuzuncu Yil University from June 2021 to September 2022. Thirty patients received single-dose methotrexate, while the other thirty received letrozole + single-dose methotrexate. Inclusion criteria were ß-hCG <5000 mIU/mL, ectopic mass <3-4 cm, no persistent abdominal pain, no fetal cardiac activity, and no contraindications to the treatments. Outcomes measured included treatment success, blood parameter changes, and the need for surgical intervention.
- Conditions
- Ectopic Pregnancy
- Being tested
- Letrozole, Methotrexate
- Keywords
- methotrexate, letrozole
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Patients in the MTX + letrozole group received letrozole tablets (Femara 2.5 mg) once daily for ten days starting from the day of MTX administration.
MethotrexateDrug
After confirming the diagnosis of tubal ectopic pregnancy, each patient will receive a single dose of intramuscular MTX (50 mg/m² MTX) on the same day
| Study group | Role | What they receive |
|---|---|---|
| Letrozole + Single-Dose Methotrexate Group | Active comparator | Patients in the MTX + letrozole group received letrozole tablets (Femara 2.5 mg) once daily for ten days starting from the day of MTX administration. Receives: Drug: Letrozole |
| Single-Dose Methotrexate | Active comparator | After confirming the diagnosis of tubal ectopic pregnancy, each patient received a single dose of intramuscular MTX (50 mg/m² MTX) on the same day. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in β-hCG levels
Serum β-hCG titration was monitored on days 1, 4, and 7 using the same laboratory kit.
Measured: On day 1, 4 and 7
Secondary outcomes (2)
Need of surgical interventions
Measured: On the days of admission.
Hospitalization Days
Measured: Through study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start20 Sep 2021
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Metin Ayğar, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504082
- Sponsor's protocol ID
- YuzuncuYıl_MTX_LTZ
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared directly upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT06504082
- Acronym / sponsor ID
- YuzuncuYıl_MTX_LTZ
- Conditions
- Ectopic Pregnancy
- Keywords
- methotrexate, letrozole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 16 Jul 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.
The objective of the study is to compare the effectiveness of single-dose methotrexate and letrozole + single-dose methotrexate in treating ectopic pregnancy, focusing on treatment success, changes in ß-hCG levels, hemogram and biochemical markers, surgical intervention due to rupture, fertility preservation, and reduction of maternal morbidity, mortality, and healthcare costs. This is a prospective study conducted on 60 ectopic pregnancy patients at Van Yuzuncu Yil University from June 2021 to September 2022. Thirty patients received single-dose methotrexate, while the other thirty received letrozole + single-dose methotrexate. Inclusion criteria were ß-hCG <5000 mIU/mL, ectopic mass <3-4 cm, no persistent abdominal pain, no fetal cardiac activity, and no contraindications to the treatments. Outcomes measured included treatment success, blood parameter changes, and the need for surgical intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole + Single-Dose Methotrexate Group | Active comparator | Drug: LetrozolePatients in the MTX + letrozole group received letrozole tablets (Femara 2.5 mg) once daily for ten days starting from the day of MTX administration. |
| Single-Dose Methotrexate | Active comparator | Drug: MethotrexateAfter confirming the diagnosis of tubal ectopic pregnancy, each patient received a single dose of intramuscular MTX (50 mg/m² MTX) on the same day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients diagnosed with ectopic pregnancy according to the diagnostic criteria
- Patients with β-hCG levels <5000 mIU/ml,
- Patients without serious or persistent abdominal pain
- Patients without fetal cardiac activity observed
- Ectopic mass size smaller than 3-4 cm
Key exclusion criteria (7 listed)
- Ruptured ectopic pregnancies
- Hemodynamically unstable patients
- Patients with acute abdomen or intra-abdominal bleeding
- Patients with fetal cardiac activity
- β-hCG levels below 500 mIU/mL or above 5000 mIU/mL
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 |
|---|---|---|
| LetrozolePatients in the MTX + letrozole group received letrozole tablets (Femara 2.5 mg) once daily for ten days starting from the day of MTX administration. | Drug | Letrozole + Single-Dose Methotrexate Group |
| MethotrexateAfter confirming the diagnosis of tubal ectopic pregnancy, each patient will receive a single dose of intramuscular MTX (50 mg/m² MTX) on the same day | Drug | Single-Dose Methotrexate |
Primary outcome
Decrease in β-hCG levels
Time frame: On day 1, 4 and 7
Serum β-hCG titration was monitored on days 1, 4, and 7 using the same laboratory kit.
2 secondary outcomes
Need of surgical interventions
Time frame: On the days of admission.
Hospitalization Days
Time frame: Through study completion, an average of 3 weeks
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 25 Jul 2025.
- Individual participant dataSharing planned: No. IPD will be shared directly upon reasonable request.
Related trials for Ectopic Pregnancy
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Sequential vs. Combined Letrozole and Methotrexate for Tubal Ectopic Pregnancy.
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Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
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Expediting Pregnancy of Unknown Location Risk Stratification Using the ROM-Plus Point of Care Test
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Letrozole Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy
Ectopic Pregnancy
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole and Methotrexate in people with Ectopic Pregnancy, run by Yuzuncu Yil 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 6 inclusion and 7 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 25 Jul 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 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?
Decrease in β-hCG levels (time frame: On day 1, 4 and 7). 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 25 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.