Letrozole add-on in the Treatment of Cesarean Scar Pregnancy

NCT05839574 | Completed DMC

• 1 other identifier: 1072.6120.46.2021
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cesarean Scar Pregnancy

Keywords

cesarean scar pregnancy; operative hysteroscopy

Outcome Measures

Primary Outcomes (3)

• 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

  up to 6 months

• Blood loss volume during the procedure expressed in volume units

  The volume of blood lost during the procedure in ml

  up to 6 months

• 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

  up to 6 months

Secondary Outcomes (9)

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

  up to 6 months

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

  up to 6 months

• The effect of treatment on bone marrow function (platelets)

  up to 6 months

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

  up to 6 months

• The effect of treatment on liver function (alanine transaminase)

  up to 6 months

Study Arms (2)

MTX in monotherapy

ACTIVE COMPARATOR

Combined treatment with MTX followed by hysteroscopic evacuation of POC

Drug: MTX monotherapy

MTX + letrozole add-on

ACTIVE COMPARATOR

Combined treatment with MTX + letrozole add-on followed by hysteroscopic evacuation of POC

Drug: MTX + letrozole add-on

Interventions

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 in monotherapy

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)

MTX + letrozole add-on

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• heterotopic pregnancy
• decreasing B-hCG concentrations

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

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

Krakow, 31-501, Poland

Location

Study Officials

• Iwona M. Gawron, M.D., Ph.D.

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

• Robert Jach, Prof., Ph.D.

  Jagiellonian University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., Principal Investigator

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: May 3, 2023
• Study Start: January 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: October 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)