Administration of granulocyte colony-stimulating factor (G-CSF) to an unresponsive endometrium in an IVF cycle

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000907943

Enrollment

Registered

2011-08-24

Start date

2012-07-30

Completion date

2020-06-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 45 Years

Healthy volunteers

Inclusion criteria

thin endometrium unresposive to oral and topical oestrogen therapy prior to embryo replacement

Exclusion criteria

women with a responsive endometrium as part of their IVF cycle

Outcome results