## Protocol Section
### Identification Module
**NCT ID:** NCT04749979

**Brief Title:** Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin

**Official Title:** Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin in IVF Cycles

#### Organization Study ID Info
**ID:** Oocyte
#### Organization
**Class:** OTHER
**Full Name:** Aljazeera Hospital
### Status Module
#### Completion Date
**Date:** 2021-07-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-02-11

**Type:** ACTUAL

**Last Update Submit Date:** 2021-02-10

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-06-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02-05

**Type:** ESTIMATED

**Status Verified Date:** 2021-02

#### Study First Post Date
**Date:** 2021-02-11
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-29
**Study First Submit QC Date:** 2021-02-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Cairo University

#### Lead Sponsor

**Class:** OTHER

**Name:** Aljazeera Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Estradiol valerate in the form of cycloprogenova™ (white tablet only) was started on day 2 or 3 of cycle with oral dose 4 mg divided on 2 doses in addition to Aspocid 75 mg once daily with folic acid 500 mcg once daily.

**Detailed Description:** U/S was done on day 9 or 10 of cycle to assess endometrial thickness, then every other day until endometrial thickness of 8 mm or more is reached and when endometrial thickness reaches 8 mm or more FET was planned. Progesterone in the form of prontogest™ 400 mg vaginal suppository twice dTwo to Four Day 5 Embryos was transferred

### Conditions Module

**Conditions:**

- Infertility

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Giving women agonist

**Intervention Names:**

- Drug: Agonist (decapeptyl )

**Label:** giving agonist ( eg. decapeptyl )

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Giving women HCG

**Intervention Names:**

- Drug: HCG ( eg. Choriomon )

**Label:** Giving HCG (eg. choriomon )

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- giving agonist ( eg. decapeptyl )

**Description:** giving agonist

**Name:** Agonist (decapeptyl )

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Giving HCG (eg. choriomon )

**Description:** giving HCG

**Name:** HCG ( eg. Choriomon )

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** how many good quality embryos

**Measure:** the number of good quality embryos

**Time Frame:** within 5 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* PCOS patients according to Rotterdam criteria
* Female age between 20 and 40 years.
* Primary or secondary infertility.
* Body mass index (BMI) between 18 and 40 kg/m2.

Exclusion Criteria:

* Ovarian endometriosis.

  * Ovarian cysts before induction.
  * Known uncontrolled endocrinal abnormalities (like hypo or hyperthyroidism)

**Gender Based:** True

**Gender Description:** females candidate for ICSI

**Healthy Volunteers:** True

**Maximum Age:** 42 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### 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, PhD

- **Phone:** +201002611058

- **Phone Ext:** +2

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Aljazeera( Al Gazeera) hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Algezeera hospitaland National Research Centre ,Egypt

**Name:** Mahmoud Alalfy, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000091662

- Term: Genital Diseases

- 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

### Condition Browse Module - Browse Leaves

- ID: M10290

- Name: Infertility

- Relevance: HIGH

- As Found: Infertility

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007246

- Term: Infertility

### Intervention Browse Module - Ancestors

- ID: D000008186

- Term: Luteolytic Agents

- ID: D000003271

- Term: Contraceptive Agents, Female

- ID: D000003270

- Term: Contraceptive Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000080066

- Term: Contraceptive Agents, Hormonal

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19618

- Name: Triptorelin Pamoate

- Relevance: HIGH

- As Found: Passed

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M6495

- Name: Contraceptive Agents, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2116

- Name: Contraceptive Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017329

- Term: Triptorelin Pamoate

### Misc Info Module

- Version Holder: 2024-05-24
