Freeze All on Oocyte Maturatin by Gonadotropin Agonist Ve... | NCT04749979

Studies
Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin

NCT04749979

Sponsor

Aljazeera Hospital

Status

Unknown status

Last Update Posted

Feb 11, 2021Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

Agonist (decapeptyl )
HCG ( eg. Choriomon )

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2021Estimated

Primary Completion Date

Jun 25, 2021Estimated

Completion Date

Jul 1, 2021Estimated

First Submitted Date

Jan 29, 2021

First Submission Date that Met QC Criteria

Feb 10, 2021

First Posted Date

Feb 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2021

Last Update Posted Date

Feb 11, 2021Actual

Name	Class
Cairo University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
giving agonist ( eg. decapeptyl )	Active Comparator	Giving women agonist	Drug: Agonist (decapeptyl )
Giving HCG (eg. choriomon )	Active Comparator	Giving women HCG	Drug: HCG ( eg. Choriomon )

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Agonist (decapeptyl )	Drug	giving agonist	giving agonist ( eg. decapeptyl )

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the number of good quality embryos	how many good quality embryos	within 5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

females candidate for ICSI

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Alalfy	Contact	01002611058		mahmoudalalfy@ymail.com

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy, PhD	Algezeera hospitaland National Research Centre ,Egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aljazeera( Al Gazeera) hospital		Giza			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017329	Triptorelin Pamoate

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided