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Letrozole Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy

2026년 5월 30일 업데이트: Aya fekry saad bahnasy, Kafrelsheikh University
The aim of work is to study the effectiveness of letrozole in treatment of early undisturbed ectopic pregnancy in comparison with Methotrexate.

연구 개요

상태

아직 모집하지 않음

상세 설명

Ectopic pregnancy (EP) was defined as the implantation of fertilized ovum anywhere other than the endometrial uterine cavity and accounts for 1-2% of all pregnancies , but its prevalence after assisted reproduction trials was found to be higher. Tubal EP (TEP) is the commonest and is associated with a high risk of rupture leading to extensive bleeding and complicated surgery,so it represents asignificant threat to maternal life . Management of Ectopic pregnancy is still a source of debate where surgical management; salpingotomy or salpingectomy is curative but insufficient removal of the ectopic tissue may occur with salpingotomy causing persistent trophoblast tisseue . Other sites of ectopic pregnancy including, cervix, myometrium, ovary, abdominal cavity.

Heterotopic pregnancy refers to coexistence of an intrauterine pregnancy with an ectopic pregnancy in any these locations.

The classic clinical triad of ectopic pregnancy is pain, amenorrhea, and vaginal bleeding; unfortunately, only about 50% of patients present with all 3 symptoms. About 40-50% of patients with an ectopic pregnancy present with vaginal bleeding, 50% have a palpable adnexal mass, and 75% may have abdominal tenderness.The availability of transvaginal ultrasonography (TVU) and serum βhuman chorionic gonadotropin (βhCG) assay allowed early diagnosis of EP and paved the way for medical treatment of EP, but within certain conditions .

A standard treatment option for many patients of ectopic pregnancy , Single- and multi-dose systemic methotrexate (MTX) protocols are used most commonly, with no difference in success rate. Given its simplicity and low complication rate, the singledose protocol is used more widely throughout the world . The single dose regimen consists of an intramuscular injection (IM) of MTX (50 mg/m2 of body surface area), with administration of additional doses at weekly intervals in patients with an inadequate response. Repeated injections are permitted every 7 days for up to 3 doses second dose is needed in 20 % or more of patients, while less than 1 % of patients require 3 or more doses. The single dose regimen is associated with fewer side effects as compared to other regimens . Methotrexate is a folic acid antagonist that inhibits the enzyme dihydrofolate reductase, which converts folic acid to tetrahydrofolate, a cofactor needed in DNA and RNA synthesis . By inhibiting dihydrofolate reductase, methotrexate interrupts trophoblast proliferation and induces abortion. Methotrexate is as effective as salpingostomy for ectopic pregnancy and does not appear to affect future fertility .However, no dose of MTX is immune against side effects even small doses . Multiple studies documented the safety and efficacy of single-dose methotrexate (SD-MTX) as a medical treatment for EP that in carefully selected cases might be an effective alternative to surgery . However, the efficacy of SD-MTX is recently questionable and multiple studies tried to evaluate the efficacy of two-dose versus SD-MTX for the medical management of EP. Third-generation aromatase inhibitors such as letrozole are well established in clinical use for suppressing estrogen production in women with breast cancer. Their safety, high tolerability, low cost, and associated minimal adverse effects have all been established over several decades of clinical use .This group of aromatase inhibitors including, letrozole, has been shown to Successfully block estrogen production in reproductive age.

In the absence of estrogen priming, progesterone may not exert its physiological functions due to a negative effect on progesterone receptors. It was hypothesized that by inhibiting the estrogen synthetase (the aromatase enzyme), the progesterone would not exert its physiological function in maintaining pregnancy, including ectopic pregnancyPrevious study evaluate the effective role of adding letrozole to methotrexate in management of tubal ectopic pregnancy. our study will aim to compare between the effect of methotrexate versus letrozoe in management of ectopic pregnancy.

연구 유형

중재적

등록 (추정된)

70

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Aya Fekry Saad Bahnasy, Obstetrics&Gynecology resident
  • 전화번호: +201092178164
  • 이메일: ayafekry772@gmail.com

연구 연락처 백업

  • 이름: Mostafa Farag Ellakany, Obstetrics&Gynecology Lecturer
  • 전화번호: +2010116083210
  • 이메일: mfe_2014@yahoo.com

연구 장소

    • Kafr el-Sheikh Governorate
      • Kafr ash Shaykh, Kafr el-Sheikh Governorate, 이집트, 33511
        • Kafr El-Sheikh University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Confirmed ectopic pregnancy on trans vaginal ultrasound
  • Age between 20 and 35 years
  • A β-hCG levels < 3000 Iu/ L
  • The average diameter of the adnexal mass ≤3.5 cm
  • Stable hemodynamic condition

Exclusion Criteria:

  • Presence of fetal heart pulsation
  • Heterotopic pregnancy
  • Presence of significant abdominal pain
  • history of allergic reactions to MTX or letrozole
  • Any known liver disorder or abnormal liver enzyme levels (AST or ALT )
  • Any known renal disorder or impaired renal function tests (abnormal creatinine)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Methotrexate
Group 1 : 35 of patients with early undisturbed ectopic pregnancy will receive methotrexate (1mg\kg IM) and follow up by β-hCG on day 4 and day 7 of first dose at Clinical Pathology Department ., Faculty of Medicine, Kafrelsheikh University Hospitals. At day 7 If β-hCG decrease >15% than day 4 , β-hCG will be repeated weekly till negative but If β-hCG decrease < 15% than day 4 second dose of methotrexate will be given 50mg/m2 IM and follow up weekly (maximum dose is 4 doses) .
Methotrexate is a folic acid antagonist that inhibits the enzyme dihydrofolate reductase, which converts folic acid to tetrahydrofolate, a cofactor needed in DNA and RNA synthesis
활성 비교기: Letrozole
Groub 2 : 35 of patients with early undisturbed ectopic pregnancy will receive letrozole (2.5 mg three times daily) for 10 days and follow up by β-hCG on day 4 and day 7 of first dose at Clinical Pathology Department, Faculty of Medicine, Kafrelsheikh University Hospitals . Patients who had no success response to letrozole (β-hCG not decreased by 30% after 10 days ) , laparoscopy will be done .
Aromatase inhibitors has been shown toSuccessfully block estrogen production In the absence of estrogen priming, progesterone may not exert its physiological functions due to a negative effect on progesterone receptors. It was hypothesized that by inhibiting the estrogen synthetase (the aromatase enzyme), the progesterone would not exert its physiological function in maintaining pregnancy, including ectopic pregnancy

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Resolution of complain
기간: β-hCG will be repeated weekly till negative or until the maximum dose of medication is reached (four doses of Methotrexate , whichever comes first).
follow up by β-hCG on day 4 and day 7 of first dose
β-hCG will be repeated weekly till negative or until the maximum dose of medication is reached (four doses of Methotrexate , whichever comes first).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Walid Mamdouh Atallah, OBGYN Professor, Tanta University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 7월 1일

연구 등록 날짜

최초 제출

2026년 5월 23일

QC 기준을 충족하는 최초 제출

2026년 5월 30일

처음 게시됨 (실제)

2026년 6월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 30일

마지막으로 확인됨

2026년 5월 1일

추가 정보

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아니요

약물 및 장치 정보, 연구 문서

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

자궁외 임신에 대한 임상 시험

Methotrexate (drug)에 대한 임상 시험

구독하다