A Phase 2 interventional study of Methotrexate (drug) and Letrozole 2.5Mg Tab in Ectopic Pregnancy, sponsored by Kafrelsheikh University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Kafrelsheikh University · Phase 2, Interventional, and Treatment
The aim of work is to study the effectiveness of letrozole in treatment of early undisturbed ectopic pregnancy in comparison with Methotrexate.
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.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) .
Drug: Methotrexate (drug)
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 .
Drug: Letrozole 2.5Mg Tab
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
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
Resolution of complain
follow up by β-hCG on day 4 and day 7 of first dose
Time frame: β-hCG will be repeated weekly till negative or until the maximum dose of medication is reached (four doses of Methotrexate , whichever comes first).
Plan to share: No
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Studies of the drugs tested here: Methotrexate · Letrozole