## Protocol Section
### Identification Module
**NCT ID:** NCT06426979

**Brief Title:** Sequential Letrozole and Methotrexate Therapy Role in Treatment of Tubal Ectopic Pregnancy

**Official Title:** Sequential Letrozole and Methotrexate Therapy Safely Improved the Outcomes of Medical Treatment of Tubal Ectopic Pregnancy

#### Organization Study ID Info
**ID:** ZU-IRB#254 24/3-2024
#### Organization
**Class:** OTHER_GOV
**Full Name:** Zagazig University
### Status Module
#### Completion Date
**Date:** 2024-01-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-06-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Zagazig University

#### Responsible Party

**Investigator Affiliation:** Zagazig University

**Investigator Full Name:** Walid Mohamed Elnagar

**Investigator Title:** Assistant professor of Gynecology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Ectopic pregnancy (EP) is a common condition involving the implantation of fertilized ovum outside the uterine cavity, accounting for 1-2% of all pregnancies. Tubal EP (TEP) is the most common and poses a significant risk to maternal life. Early diagnosis and medical treatment, such as methotrexate (MTX) and the Fallopian tube (FT), have been studied. However, the efficacy of single-dose methotrexate (SD-MTX) is questionable, and the efficacy of two-dose versus SD-MTX for medical management of EP is being evaluated. High estrogens/progesterone ratios can disrupt embryonic motility and lead to TEP.

### Conditions Module

**Conditions:**

- Pregnancy Tubal

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Patients were divided into 2 Groups as the group titles were printed into cards that were enclosed in sealed envelopes and patients were asked to choose a closed envelop.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Letrozole and Methotrexate Therapy's Group

**Intervention Names:**

- Drug: Methotrexate

- Drug: Letrozole

**Label:** Group LTZ-MTX

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Methotrexate Therapy's Group

**Intervention Names:**

- Drug: Methotrexate

**Label:** Group MTX

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group LTZ-MTX

- Group MTX

**Description:** Methotrexate 25 mg/ml was given as single-dose of intramuscular (IM) injection in a dose of 50 mg/m2.

**Name:** Methotrexate

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Group LTZ-MTX

**Description:** FEMARA 2.5 mg tablets two tablets daily

**Name:** Letrozole

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Role of Letrozole in resolution of Tubal Ectopic Pregnancy (TEP) that was confirmed by TVU and without shifting to surgery.

**Measure:** The Rate of resolution of Tubal Ectopic Pregnancy (TEP)

**Time Frame:** 9 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Presence of gestational masses of \<3.5 cm in its greatest diameter in an intact uterine tube and showed no fetal cardiac activity;
* Absence of hemodynamic manifestations or evidence of intra-peritoneal bleeding on TVU and pre-treatment serum hCG of \<3500 IU/L.

Exclusion Criteria:

* Free of Inclusion Criteria

**Maximum Age:** 60 Years

**Minimum Age:** 22 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Zagazig

**Country:** Egypt

**Facility:** Zagazig university

**State:** Ash Sharqia Governorate

**Zip:** 44519

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14147

- Name: Pregnancy, Ectopic

- Relevance: HIGH

- As Found: Ectopic Pregnancy

- ID: M14150

- Name: Pregnancy, Tubal

- Relevance: HIGH

- As Found: Tubal Ectopic Pregnancy

- ID: M8260

- Name: Cardiac Complexes, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T2035

- Name: Ectopic Pregnancy

- Relevance: HIGH

- As Found: Ectopic Pregnancy

### Condition Browse Module - Meshes

- ID: D000011271

- Term: Pregnancy, Ectopic

- ID: D000011274

- Term: Pregnancy, Tubal

### Intervention Browse Module - Ancestors

- ID: D000000020

- Term: Abortifacient Agents, Nonsteroidal

- ID: D000000019

- Term: Abortifacient Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000003879

- Term: Dermatologic Agents

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000005493

- Term: Folic Acid Antagonists

- ID: D000007166

- Term: Immunosuppressive Agents

- ID: D000007155

- Term: Immunologic Factors

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

- ID: D000047072

- Term: Aromatase Inhibitors

- ID: D000065088

- Term: Steroid Synthesis Inhibitors

- ID: D000004965

- Term: Estrogen Antagonists

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M11703

- Name: Methotrexate

- Relevance: HIGH

- As Found: Condition

- ID: M1743

- Name: Letrozole

- Relevance: HIGH

- As Found: Visual

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8618

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M17546

- Name: Vitamin B Complex

- Relevance: LOW

- As Found: Unknown

- ID: M8619

- Name: Folic Acid Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M10212

- Name: Immunosuppressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M25769

- Name: Aromatase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8116

- Name: Estrogens

- Relevance: LOW

- As Found: Unknown

- ID: M8114

- Name: Estrogen Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M30483

- Name: Estrogen Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: T447

- Name: Folinic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T446

- Name: Folic Acid

- Relevance: LOW

- As Found: Unknown

- ID: T448

- Name: Folate

- Relevance: LOW

- As Found: Unknown

- ID: T475

- Name: Vitamin B9

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008727

- Term: Methotrexate

- ID: D000077289

- Term: Letrozole

### Misc Info Module

- Version Holder: 2024-05-31
