NCT01315470

Brief Summary

The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of recurrent implantation failure in IVF patient with cause unknown or due to thin endometrium. Several studies showed that GCSF improves embryo development and implantation and increase pregnancy rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 24, 2011

Status Verified

March 1, 2011

Enrollment Period

1.6 years

First QC Date

March 14, 2011

Last Update Submit

March 23, 2011

Conditions

Infertility

Keywords

improving pregnancy rate and endometrial thickness

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    18 months

Secondary Outcomes (2)

  • endometrial thickness during IVF treatment

    18 months

  • endometrial thickness

    18 months

Study Arms (2)

neupogen

EXPERIMENTAL
Drug: neupogen administration for women with recurrent IVF failure

no intervantion

NO INTERVENTION

Interventions

neupogen administration for women with recurrent IVF failureDRUG

neupogen 300 mcg - twice

Also known as: GCSF injection, filgrastim
neupogen

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women after 5 failures in IVF cycles with cause unknown.
  • women after 5 failures in IVF due to thin endometrium (\<6 mm) and unresponsive to estrogen supplements.

You may not qualify if:

  • history of hematology disease
  • allergy to GCSF
  • neutrophilia
  • severe lower back pain
  • liver dysfunction
  • hyperuricemia
  • a recent febrile disease or pneumonia
  • rheumatoid arthritis 9. sickle cell disease-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hadassah Ein Karem

Jerusalem, Israel, Israel

Location

Hadassah Ein Karem

Jerusalem, Israel

Location

Related Links

MeSH Terms

Conditions

Infertility

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • einat zivi, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

einat zivi, MD

CONTACT

0508573943zivi_e@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

June 1, 2011

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

March 24, 2011

Record last verified: 2011-03

Locations

IL(2)