Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Letrozole Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy

30 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

70

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Aya Fekry Saad Bahnasy, Obstetrics&Gynecology resident
  • Numero di telefono: +201092178164
  • Email: ayafekry772@gmail.com

Backup dei contatti dello studio

  • Nome: Mostafa Farag Ellakany, Obstetrics&Gynecology Lecturer
  • Numero di telefono: +2010116083210
  • Email: mfe_2014@yahoo.com

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Comparatore attivo: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Resolution of complain
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Walid Mamdouh Atallah, OBGYN Professor, Tanta University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 luglio 2027

Date di iscrizione allo studio

Primo inviato

23 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 maggio 2026

Primo Inserito (Effettivo)

3 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Methotrexate (drug)

Sottoscrivi