Primary Ovarian Insufficiency, Premature Ovarian Failure
Conditions
Keywords
Filgrastim, Granulocyte colony stimulating factor, Premature Ovarian Insufficiency, Neupogen
Brief summary
The goal of this pilot study is to improve ovarian reserve markers in patients with premature ovarian insufficiency. The main question it aims to answer is: \- Will treatment with G-CSF allow improvement in markers of ovarian reserve?
Detailed description
The research team hypothesize that treatment of premature ovarian insufficiency patients with G-CSF to mobilize bone marrow hematopoietic stem cells will allow for improved ovarian reserve markers including antral follicle count, anti-Mullerian hormone (AMH) levels and gonadotropin (FSH) levels. The research team anticipate these outcomes: * Primary outcome: Decreased serum FSH and increased AMH levels and u/s measurement of increased antral follicle count (AFC) * Secondary outcome: Improved ovarian response in IVF cycles if BAFs develop, and spontaneous or IVF pregnancy.
Interventions
DRUGNeupogen
Subcutaneous injection of 0.5 ml of Neupogen at a concentration of 300 micrograms/day for 4 consecutive days
Sponsors
Trio Fertility
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women ages 25-40 * Woman who meet criteria for POI defined as AFC \< 5, AMH \< 3 pmol/L and FSH \>30 IU/L. There may also be associated symptoms of the menopause such as hot flushes, night sweats, insomnia and vaginal dryness. * Women who are not taking any other medical or fertility treatments except natural estrogen to stop hot flushes. * Those who are provided with informed consent.
Exclusion criteria
* Women with age \> 40 * Women with history of autoimmune disorders * Women with a history of hematopoietic cell malignancies * Women with sickle cell disease * Women with any other comorbidities that would preclude infertility treatment and pregnancy such as HIV/AIDS, hepatitis B or C, breast cancer or body mass index (BMI) \>40.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improving ovarian reserve markers | It is anticipated within six months | Success of the treatment will be assessed by a change in serum FSH, AMH (measure of ovarian reserve) and number of antral follicles (AFC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Pregnancy | It is anticipated after the first six months of the study time frame | If a change in the number of basal antral follicles is seen in association with an FSH level below 20 IU/L, the subjects will be offered a cycle of IVF to see if oocytes and subsequently embryos can be obtained. |
Countries
Canada
Outcome results
None listed