## Protocol Section
### Identification Module
**NCT ID:** NCT03498079

**Brief Title:** Prevalence of Mullerian Anomalies in Infertile Women

**Official Title:** Prevalence of Mullerian Anomalies and PCO in Egyptian Women

#### Organization Study ID Info
**ID:** mullerian anomalies
#### Organization
**Class:** OTHER
**Full Name:** Aljazeera Hospital
### Status Module
#### Completion Date
**Date:** 2019-04-25

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-01-09

**Type:** ACTUAL

**Last Update Submit Date:** 2019-01-08

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-04-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-04-16

**Type:** ACTUAL

**Status Verified Date:** 2019-01

#### Study First Post Date
**Date:** 2018-04-13
**Type:** ACTUAL
**Study First Submit Date:** 2018-04-07
**Study First Submit QC Date:** 2018-04-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Kasr El Aini Hospital

**Class:** OTHER

**Name:** National Research Centre, Egypt

**Class:** UNKNOWN

**Name:** misr Infertility centre ,Alaqsor

#### Lead Sponsor

**Class:** OTHER

**Name:** Aljazeera Hospital

#### Responsible Party

**Investigator Affiliation:** Aljazeera Hospital

**Investigator Full Name:** Mahmoud Alalfy

**Investigator Title:** Assistant Researcher , National Research centre and Specialist of Obstetrics and Gynecology in Aljazeerah hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** * Mullerian anomalies are congenital structural anomalies in the uterus .
* Its prevalence is not uncommon .

**Detailed Description:** * PCO is very common in gynecological practice
* Women with mullerian anomalies should be properly evaluated for other gynecological and urological problems

### Conditions Module

**Conditions:**

- Mullerian Anomaly of Uterus

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 250

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 4 Weeks

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 3D ultrasound will be done to females complaining from primary infertility with mullerian anomalies

**Name:** 3D ultrasound

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** diagnosis of PCO by US and by FSH and LH levels

**Measure:** the number of participants who will prove to have PCO

**Time Frame:** within 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* females with age between 20-42 years with primary infertility

Exclusion Criteria:

* females with age above 42 years or below 20 years females with secondary infertility

**Gender Based:** True

**Gender Description:** females with primary infertility

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 20 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** - females with age between 20-42 years with primary infertility

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mahmoudalalfy@ymail.com

**Name:** Mahmoud Alalfy

**Phone:** 01002611058

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Giza

**Contacts:**

***Contact 1:***

- **Email:** mahmoudalalfy@ymail.com

- **Name:** Mahmoud Alalfy, master

- **Phone:** +201002611058

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ahmed Elgazzar, M.D

- **Phone:** +201014005959

- **Role:** CONTACT

***Contact 3:***

- **Name:** Mahmoud Alalfy, master

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Egypt

**Facility:** Algazeerah

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

**Name:** Mahmoud Alalfy

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** we will publish the results which will be obtained from this study

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXS

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

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M10290

- Name: Infertility

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: HIGH

- As Found: Anomalies

### Condition Browse Module - Meshes

- ID: D000000013

- Term: Congenital Abnormalities

### Misc Info Module

- Version Holder: 2024-05-24
