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Completed

NCT Number: NCT05839574

Letrozole add-on in the 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.

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Key information

Conditions

Cesarean Scar Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Krakow, 31-501, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • heterotopic pregnancy
  • decreasing B-hCG concentrations

Treatment and study plan

MTX monotherapy

Drug

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-on

Drug

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)

Primary outcomes

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

    The volume of blood lost during the procedure in ml

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

    Time frame: up to 6 months

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

Secondary outcomes

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

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

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 3, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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