Use of Gcsf in Patients With Recurrent Ivf/Icsi Failure | NCT03023774

Studies
Use of Gcsf in Patients With Recurrent Ivf/Icsi Failure

NCT03023774

Sponsor

Ain Shams Maternity Hospital

Status

Completed

Last Update Posted

Jan 18, 2017Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Fertility Disorders

Interventions

Neupogen

Countries

Not provided

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Oct 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jan 12, 2017

First Submission Date that Met QC Criteria

Jan 13, 2017

First Posted Date

Jan 18, 2017Estimated

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

Jan 13, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr wessam magdi abuelghar, principal investigator, Ain Shams Maternity HospitalPrincipal Investigator

Lead Sponsor

Ain Shams Maternity HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Evaluate the effectiveness of granulocyte colony-stimulating factor (GCSF) in the treatment of thin endometrium or in women with recurrent implantation failure in ICSI cycles

Detailed Description

Prospective analytical study which will be conducted at a private IVF center starting from june 2016.

the study will be recruited from both the fertility clinics and centers by fulfilling inclusion and exclusion criteria , all patient will be subjected to complete history taking medical and fertility history including previous induction or implantation failure.

patients will be randomized into two groups, group A will be treated with neupogen 30 international unit (IU) and group B will be treated with clexane 40mg and estrogen.

study procedure: ovaries were stimulated with standard protocol (long GnRH Agonist) or gonadotrophic releasing hormone (GnRH Antagonist, when at least 3 follicles achieved 18 mm diameter, Human chorionic gonadotrophic (hCG) (10000 IU) was administered for ovulation triggering, transvaginal oocyte retrieval was performed at 36-38 hours after injection of hCG . the oocytes were fertilized by intracytoplasmic sperm injection (ICSI) method. the thickness of endometrium was evaluated on the day of oocyte retrieval and syringe which containing (300 mcg/1 ml) GCSF (neupogen) was infused slowly in the uterine cavity and after 5 days (before embryo transfer) endometrial thickness was evaluated again. all patients received oral and parenteral progesterone for luteal phase support.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
neupogen	Other	neupogen (granulocyte colony-stimulating factor) 30 IU once intrauterine at the time of ovum pickup	Drug: Neupogen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neupogen	Drug	neupogen 30 IU once intrauterine at the time of ovum pickup	neupogen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
increase in endometrial thickness (above 7 mm)		one week

Secondary Outcomes

Measure	Description	Time Frame
chemical pregnancy (serum beta hCG titre more than (25 mili liter international unit (mIU)/ml) and clinical pregnancy defined as the presence of an intrauterine gestational sac on transvaginal ultrasound (TVS)as 6 weeks.		6 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male partner with normal semen analysis according to world health organization (WHO) 2010.
female partner under the age of 36 presented with: a-thin endometrium (less 7 mm on transvaginal ultrasound) or b- previous history multiple unexplained
female with no history of Asherman's syndrome , fibroids, and polyps in diagnostic hysteroscopy

Exclusion Criteria:

women with sickle cell disease, renal insufficiency, upper respiratory infection or pneumonia, chronic neutropenia, known past or present malignancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

36 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Female 35 years maximum have failed icsi due to low endometrium thickness

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069585	Filgrastim
D016179	Granulocyte Colony-Stimulating Factor

Ancestor Terms

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates

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