Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000907943
Ethics application status
Approved
Date submitted
14/06/2011
Date registered
24/08/2011
Date last updated
6/06/2019
Date data sharing statement initially provided
6/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Administration of granulocyte colony-stimulating factor (G-CSF) to an unresponsive endometrium in an IVF cycle
Scientific title
The effect of granulocyte colony-stimulating factor (G-CSF) on endometrial thickness in patients who fail to develop an adequate endometrial thickness as part of an IVF cycle
Secondary ID [1] 262374 0
Nil Known
Universal Trial Number (UTN)
U1111-1122-1627
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
unresponsive endometrium 268080 0
Condition category
Condition code
Reproductive Health and Childbirth 268227 268227 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Granulocyte colony-stimulating factor (G-CSF).
300micrograms in 1 ml saline administered through the cervix, into the uterine cavity as a single dose via an embryo transfer catheter 5 days prior to blastocyst replacement.
Intervention code [1] 266767 0
Treatment: Drugs
Comparator / control treatment
The patient will act as their own internal control, as to be included their endometrium has not thickened despite optimal therapy and have not developed an endometrium of greater than 7.0mm in thickness.

They must have embarked on a natural cycle, hormone replacement stimulated cycle and a gonadotrophin hormone stimulated cycle (in any order) and have not developed an endometrial thickness of 7mm by any approach within the preceding year.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 268963 0
improvement in endometrial thickness as assessed by transvaginal ultrasonography.
Timepoint [1] 268963 0
5 days
Primary outcome [2] 268964 0
livebirth rate
Timepoint [2] 268964 0
9 months
Secondary outcome [1] 276703 0
Adverse events; such as pelvic pain, vaginal bleeeding and allergic reactions as reported by the patient and healthcare professionals.
Timepoint [1] 276703 0
Within 24 hours of intervention
Secondary outcome [2] 276704 0
miscarriage
Timepoint [2] 276704 0
20 weeks of pregnancy

Eligibility
Key inclusion criteria
thin endometrium unresposive to oral and topical oestrogen therapy prior to embryo replacement
Minimum age
No limit
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
women with a responsive endometrium as part of their IVF cycle

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients who have an unresponsive endometrium will be offered the intervention. As they will be unrepsonsive to treatment- they will be therefore act as their own historical control; pre and post intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
non-randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2011
Actual
30/07/2012
Date of last participant enrolment
Anticipated
1/06/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 267332 0
Self funded/Unfunded
Name [1] 267332 0
Country [1] 267332 0
Primary sponsor type
Commercial sector/Industry
Name
Fertility Specialists of Western Australia
Address
Bethesda Hospital
25 Queenslea Drive
Claremont
WA
6010
Country
Australia
Secondary sponsor category [1] 266397 0
None
Name [1] 266397 0
Address [1] 266397 0
Country [1] 266397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269240 0
University of Western Australia
Ethics committee address [1] 269240 0
The University of Western Australia (M459)
Crawley, Perth
Western Australia 6009
Ethics committee country [1] 269240 0
Australia
Date submitted for ethics approval [1] 269240 0
15/09/2011
Approval date [1] 269240 0
01/07/2011
Ethics approval number [1] 269240 0
RA/4/1/5082

Summary
Brief summary
There is some preliminary evidence that the endometrial administration of granulocyte colony-stimulating factor (G-CSF) several days prior to embryo replacement leads to a substantial and rapid improvement in endometrial thickness . The rationale for its use is that it is has successfully been used in the treatement of recurrent miscarriages. Granulocyte colony-stimulating factor (G-CSF) is a cytokine which stimulates neutrophilic granulocyte proliferation and differentiation. It is expressed and produced by the decidual cells, and its receptor, c-fms, is expressed by the trophoblastic cells. In addition, in an animal model, G-CSF showed a marked anti-abortion activity. G-CSF is safely used in the treatment of neutropenia during cancer chemotherapy, and no embryotoxic effects of this substance have been reported and its safety profile is reassuring. Since experimental findings showed a positive effect on the trophoblast and particularly thickening of the endometrium in previously very resistant patients we would like to prospectively observe the influence of G-CSF on endometrial development in patients with poor endometrial development. It has a very short half life and is administered to the endometrial cavity 5 days prior to embryo replacment so it is not present in the endometrial cavity when the embryo is placed in the uterus.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32745 0
Prof Roger Hart
Address 32745 0
Fertility Specialists of Western Australia
Bethesda Hospital
25 Queenslea Drive
Claremont WA6010
Western Australia
Country 32745 0
Australia
Phone 32745 0
+61 8 93406419
Fax 32745 0
Email 32745 0
[email protected]
Contact person for public queries
Name 15992 0
Professor Roger HART
Address 15992 0
Medical Director Fertility Specialists of Western Australia
Bethesda Hospital
25 Queenslea Drive
Claremont
WA6010
Country 15992 0
Australia
Phone 15992 0
+61 8 93406419
Fax 15992 0
+61 8 93813031
Email 15992 0
[email protected]
Contact person for scientific queries
Name 6920 0
Professor Roger HART
Address 6920 0
Medical Director Fertility Specialists of Western Australia
Bethesda Hospital
25 Queenslea Drive
Claremont
WA6010
Country 6920 0
Australia
Phone 6920 0
+61 8 93406419
Fax 6920 0
+61 8 93813031
Email 6920 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
patient confidentiality- patients signed up to the study before this criteria was required.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.