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Completed

NCT Number: NCT05839561

Monotherapy With Letrozole in Tubal Pregnancy

It is hypothesized that the inhibition of estradiol production by letrozole may interfere with physiological effects of progesterone necessary to maintain the pregnancy. Treatment of tubal pregnancy with letrozole would allow to avoid the adverse effects of methotrexate (MTX) in women refusing surgery. The aim was to compare the effectiveness of letrozole with MTX in the management of tubal pregnancy.

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Key information

Conditions

Tubal Pregnancy Unruptured Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Ectopic Pregnancy, Tubal Urogenital Diseases

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 tubal pregnancy. Women with increasing B-human chorionic gonadotropin (B-hCG) concentrations are included.

Two study arms were planned:

i) women treated with MTX: MTX in a single dose of 100 mg intravenously on day 0; ii) women treated with letrozole: letrozole at a daily dose of 5 mg orally for 10 days from day 0.

The inclusion criteria included B-hCG concentration up to 3000 mIU/ml and no contraindications to conservative treatment. Women who did not meet criteria for conservative treatment were excluded. Blood parameters (B-hCG, hemoglobin, creatinine, urea, alanine/aspartate transaminase, gamma-glutamyltransferase, bilirubin) were tested on days 0,4,7. Cases of treatment failure were counted, i.e. the need to perform laparoscopy due to tubal pregnancy rupture, pain, increase in B-hCG concentration.

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

  • tubal pregnancy confirmed on pelvic ultrasound
  • increasing serum B-hCG concentrations in at least two subsequent measures
  • serum B-hCG concentration ≤ 3000 mIU/ml

Exclusion criteria

  • free fluid in lesser pelvis on pelvic ultrasound
  • positive fetal heartbeat on pelvic ultrasound
  • abdominal pain
  • heterotopic pregnancy
  • contraindications to MTX

Treatment and study plan

Letrozole as monotherapy

Drug

Letrozole 5 mg daily orally for 10 days from day 0

MTX as monotherapy

Drug

MTX in a single dose of 100 mg intravenously on day 0

Primary outcomes

  1. The effectiveness of the treatment

    Time frame: up to 6 months

    Conversion rate to laparoscopy due to tubal rupture, pain, serum B-hCG increase in the course of treatment

Secondary outcomes

  1. The effect of treatment on bone marrow function (hemoglobin)

    Time frame: up to 6 months

    Changes in hemoglobin concentration (g/dl) in the course of treatment (day 0,4,7)

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

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

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

    Time frame: up to 6 months

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

  5. The effect of treatment on liver function (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)

  6. 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)

  7. 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)

  8. 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)

  9. The effect of treatment on kidney 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)

  10. The effect of treatment on kidney function (creatinine)

    Time frame: up to 6 months

    Changes in the concentrations of serum 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

Management of Tubal Pregnancy With Off-label Use of Letrozole in Monotherapy

Important dates

Study start
2020
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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