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Cesarean Scar PregnancyNCT05839574

Letrozole add-on in the Treatment of Cesarean Scar Pregnancy

A study testing MTX monotherapy and MTX + letrozole add-on in people with Cesarean Scar Pregnancy, run by Jagiellonian University at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is hypothesized that the inhibition of estradiol production by letrozole may interfere with physiological effects of progesterone necessary to maintain the pregnancy. There is no reference treatment of cesarean scar pregnancy (CSP) as the limited number of cases precludes the extrapolation of results. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Cesarean Scar Pregnancy
What is being tested?
MTX monotherapy and MTX + letrozole add-on
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 sitePoland
Study dates
1 Jan 2021to 30 Oct 2023
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

  • CSP confirmed on pelvic ultrasound
  • consent of the Bioethics Committee for termination of CSP
  • increasing B-hCG concentrations

Who cannot join

  • heterotopic pregnancy
  • decreasing B-hCG concentrations

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology

    Krakow, 31-501

Other trials in Poland

About this study

Official title: Evaluation of the Therapeutic Effect of Adding Letrozole to the Protocol of Combined Treatment of Cesarean Scar Pregnancy

It is hypothesized that the inhibition of estradiol production by letrozole may interfere with physiological effects of progesterone necessary to maintain the pregnancy. There is no reference treatment of cesarean scar pregnancy (CSP) as the limited number of cases precludes the extrapolation of results. In our center we successfully use two-step treatment with methotrexate (MTX) followed by hysteroscopic removal of products of conception (POC). The time in between is needed to achieve a decrease in the trophoblast's vital potential (B-hCG fall) and its vascularization. Additional administration of letrozole could further reduce the vital potential of the pregnancy, eliminating the need for another dose of MTX, resulting in faster healing and lower rate of complications.

Read the detailed description

A prospective cohort study is conducted among women with cesarean scar pregnancy (CSP). Women with increasing B-human chorionic gonadotropin (B-hCG) concentrations are included.

Two study arms were planned:

  • women treated with a single dose of 100 mg MTX intravenously and 50 mg MTX in intra-amniotic injection (day 0), along with 30 mg potassium chloride in case of positive fetal heartbeat (FH)
  • women treated with a single dose of 100 mg MTX intravenously and 50 mg MTX in intra-amniotic injection (day 0), along with 30 mg potassium chloride in case of positive fetal heartbeat (FH) with additional use of letrozole 5 mg orally (from day 0) for 10 days.

Blood parameters (B-hCG, hemoglobin, total blood count, creatinine, urea, alanine/aspartate transaminase, gamma-glutamyltransferase, bilirubin) were tested on days 0,4,7, followed by B-hCG concentration measurement every 7 days until surgery. After obtaining satisfactory decrease in B-hCG and POC vascularization, women underwent hysteroscopic evacuation of POC. Blood loss parameters, frequency of conversion from hysteroscopy to laparoscopy and laparotomy were measured.

The women were given the option to choose the treatment used in the study. All enrolled women gave informed written consent to participate in the study.

Being tested
MTX monotherapy, MTX + letrozole add-on
Keywords
cesarean scar pregnancy, operative hysteroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MTX monotherapyDrug

    MTX in a single dose of 100 mg intravenously and 50 mg in intra-amniotic injection (day 0), along with 30 mg potassium chloride in case of positive fetal heartbeat (FH), and subsequent hysteroscopic evacuation of products of conception (POC)

  • MTX + letrozole add-onDrug

    MTX in a single dose of 100 mg intravenously and 50 mg in intra-amniotic injection (day 0), along with 30 mg potassium chloride in case of positive fetal heartbeat (FH) + Letrozole in a daily dose of 5 mg (2 x 2.5 mg) orally for 10 days from day 0, and subsequent hysteroscopic evacuation of products of conception (POC)

Study groups in NCT05839574
Study groupRoleWhat they receive
MTX in monotherapyActive comparatorCombined treatment with MTX followed by hysteroscopic evacuation of POC
Receives: Drug: MTX monotherapy
MTX + letrozole add-onActive comparatorCombined treatment with MTX + letrozole add-on followed by hysteroscopic evacuation of POC
Receives: Drug: MTX + letrozole add-on

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood loss during the procedure expressed as a decrease in hemoglobin concentration

    Decrease in hemoglobin concentration in g/dl on day 1 after the procedure compared to the pre-procedure concentration

    Measured: up to 6 months

  2. Blood loss volume during the procedure expressed in volume units

    The volume of blood lost during the procedure in ml

    Measured: up to 6 months

  3. Conversion rate from hysteroscopy to laparoscopy or laparotomy due to due to hemorrhage

    Percentage (%) of conversion from hysteroscopy to laparoscopy or laparotomy due to hemorrhage

    Measured: up to 6 months

Secondary outcomes (9)

  1. The effect of treatment on bone marrow function (red blood cells)

    Change in red blood count (T/l) in the course of treatment (day 0,4,7)

    Measured: up to 6 months

  2. The effect of treatment on bone marrow function (white blood cells)

    Change in white blood count (G/l) in the course of treatment (day 0,4,7)

    Measured: up to 6 months

  3. The effect of treatment on bone marrow function (platelets)

    Change in platelet count (G/l) in the course of treatment (day 0,4,7)

    Measured: up to 6 months

  4. The effect of treatment on liver function (serum total bilirubin)

    Changes in the concentrations of serum total bilirubin (mg/dl) in the course of treatment (day 0,4,7)

    Measured: up to 6 months

  5. The effect of treatment on liver function (alanine transaminase)

    Changes in the concentrations of alanine transaminase (IU/l) in the course of treatment (day 0,4,7)

    Measured: up to 6 months

  6. The effect of treatment on liver function (aspartate transaminase)

    Changes in the concentrations of aspartate transaminase (IU/l) in the course of treatment (day 0,4,7)

    Measured: up to 6 months

  7. The effect of treatment on liver function (gamma-glutamyltransferase)

    Changes in the concentrations of gamma-glutamyltransferase (IU/l) in the course of treatment (day 0,4,7)

    Measured: up to 6 months

  8. The effect of treatment on kidneys function (urea)

    Changes in the concentrations of serum urea (mmol/l) in the course of treatment (day 0,4,7)

    Measured: up to 6 months

  9. The effect of treatment on kidneys function (creatinine)

    Changes in the concentrations of serum and creatinine (mg/dl) in the course of treatment (day 0,4,7)

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start1 Jan 2021
  3. Primary completion30 Dec 2022
  4. Study completion30 Oct 2023

Resources

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05839574
Sponsor's protocol ID
1072.6120.46.2021
Status last verified
Nov 2023
First submitted
15 Apr 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MTX monotherapy and MTX + letrozole add-on in people with Cesarean Scar Pregnancy, run by Jagiellonian University at 1 site in Poland.

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 3 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 18 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 Poland. 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?

Blood loss during the procedure expressed as a decrease in hemoglobin concentration (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05839574.

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 18 Nov 2023.

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