Premature Ovarian Failure
Conditions
Keywords
Premature, Ovarian, Failure, Filgrastim
Brief summary
Filgrastim is a Granulocyte-Colony Stimulating factor (G-CSF). It is an FDA approved drug. Very small embryonic-like stem cells (VSELs) are found in the ovary. Animal studies showed that these cells are able to regenerate the affected ovary. Studies on mice have shown that Filgrastim result in recovery of oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).
Detailed description
Premature ovarian insufficiency (POI) has no curative treatment until now. Filgrastim is an FDA approved Granulocyte-Colony Stimulating factor (G-CSF). Very small embryonic-like stem cells (VSELs) are found in the testis and ovary. VSELs are stem cells that have noticed to survive chemotherapy induced gonadal failure. Data from animal studies showed that stimulation of these stem cells result in generation of the affected gonads. Studies on mice have shown a promising stimulating effect of Filgrastim on recovery of spermatogenesis and oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).
Interventions
BIOLOGICALFilgrastim
Each case will have two intervention phases done blindly at random with a wash-out period of 6 months: Phase A: Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days. Phase B: Injection of saline SC injection twice daily for five consecutive days.
DRUGSaline
Injection of saline SC injection twice daily for five consecutive days
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women with Premature Ovarian Insufficiency (POI): For the purpose of the research women is considered to have POI if she is aged less than 40 years and has amenorrhea of at least 4 month with FSH level above 25 IU/L (repeated twice \>4 weeks apart).
Exclusion criteria
* Abnormal karyotype * Previous pelvic or abdominal radiotherapy * Previous surgical removal of the ovarian pathology * Chronic disease: renal, liver, cardiac, malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Return of menses | 6 months | Return of menses in patients with amenorrhea of at least 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum Estradiol | 6 months | Normalization of serum Estradiol as tested bi-weekly |
| serum Anti-mullarian Hormone (AMH) | 6 months | Normalization of serum AMH in patients with AMH level less than 0.9 ng/mL |
| Pregnancy | 6 months | Occurrence of pregnancy as diagnosed by positive serum B-hCG and/or ultrasound |
| Follicular growth | 6 months | Growth of follicle to size at least 18 mm as monitored by transvaginal ultrasound |
| endometrial thickness | 6 months | increase of endometrial thickness in women with thin endometrium (less then 8 mm) |
| serum FSH | 6 months | Normalization of serum FSH in patients with FSH level above 25 IU/L |
Outcome results
None listed