Clinical trial NCT05839574: Letrozole add-on in the Treatment of Cesarean Scar Pregnancy
Official title: Evaluation of the Therapeutic Effect of Adding Letrozole to the Protocol of Combined Treatment of Cesarean Scar Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Scar Pregnancy
Keywords: cesarean scar pregnancy
operative hysteroscopy
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood loss during the procedure expressed as a decrease in hemoglobin concentration
timeFrame: up to 6 months
measure: Blood loss volume during the procedure expressed in volume units
timeFrame: up to 6 months
measure: Conversion rate from hysteroscopy to laparoscopy or laparotomy due to due to hemorrhage
timeFrame: up to 6 months
Secondary outcomes:
measure: The effect of treatment on bone marrow function (red blood cells)
timeFrame: up to 6 months
measure: The effect of treatment on bone marrow function (white blood cells)
timeFrame: up to 6 months
measure: The effect of treatment on bone marrow function (platelets)
timeFrame: up to 6 months
measure: The effect of treatment on liver function (serum total bilirubin)
timeFrame: up to 6 months
measure: The effect of treatment on liver function (alanine transaminase)
timeFrame: up to 6 months
measure: The effect of treatment on liver function (aspartate transaminase)
timeFrame: up to 6 months
measure: The effect of treatment on liver function (gamma-glutamyltransferase)
timeFrame: up to 6 months
measure: The effect of treatment on kidneys function (urea)
timeFrame: up to 6 months
measure: The effect of treatment on kidneys function (creatinine)
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University Medical College, Department of Gynecology and Obstetrics, Clinic of Gynecological Endocrinology
Study officials:
affiliation: Jagiellonian University
name: Iwona M. Gawron, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jagiellonian University
name: Robert Jach, Prof., Ph.D.
role: STUDY_CHAIR
References: