NCT03023774

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

January 12, 2017

Last Update Submit

January 13, 2017

Conditions

Fertility Disorders

Outcome Measures

Primary Outcomes (1)

  • increase in endometrial thickness (above 7 mm)

    one week

Secondary Outcomes (1)

  • 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

Study Arms (1)

neupogen

OTHER

neupogen (granulocyte colony-stimulating factor) 30 IU once intrauterine at the time of ovum pickup

Drug: Neupogen

Interventions

NeupogenDRUG

neupogen 30 IU once intrauterine at the time of ovum pickup

Also known as: granulocyte colony-stimulating factor
neupogen

Eligibility Criteria

AgeUp to 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

FilgrastimGranulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 18, 2017

Study Start

June 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

January 18, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

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