Premature Ovarian Failure Clinical Trial
— FIL-POIOfficial title:
Filgrastim for Treatment of Premature Ovarian Insufficiency: Randomized Clinical Trial
NCT number | NCT02783937 |
Other study ID # | OBGYN001 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | June 2021 |
Verified date | September 2021 |
Source | South Valley University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 10 |
Est. completion date | June 2021 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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South Valley University |
Akdemir A, Zeybek B, Akman L, Ergenoglu AM, Yeniel AO, Erbas O, Yavasoglu A, Terek MC, Taskiran D. Granulocyte-colony stimulating factor decreases the extent of ovarian damage caused by cisplatin in an experimental rat model. J Gynecol Oncol. 2014 Oct;25(4):328-33. doi: 10.3802/jgo.2014.25.4.328. Epub 2014 Jun 18. — View Citation
Benavides-Garcia R, Joachim R, Pina NA, Mutoji KN, Reilly MA, Hermann BP. Granulocyte colony-stimulating factor prevents loss of spermatogenesis after sterilizing busulfan chemotherapy. Fertil Steril. 2015 Jan;103(1):270-80.e8. doi: 10.1016/j.fertnstert.2014.09.023. Epub 2014 Nov 5. — View Citation
Bhartiya D, Anand S, Parte S. VSELs may obviate cryobanking of gonadal tissue in cancer patients for fertility preservation. J Ovarian Res. 2015 Nov 17;8:75. doi: 10.1186/s13048-015-0199-2. — View Citation
Roness H, Kalich-Philosoph L, Meirow D. Prevention of chemotherapy-induced ovarian damage: possible roles for hormonal and non-hormonal attenuating agents. Hum Reprod Update. 2014 Sep-Oct;20(5):759-74. doi: 10.1093/humupd/dmu019. Epub 2014 May 15. Review. — View Citation
Skaznik-Wikiel ME, McGuire MM, Sukhwani M, Donohue J, Chu T, Krivak TC, Rajkovic A, Orwig KE. Granulocyte colony-stimulating factor with or without stem cell factor extends time to premature ovarian insufficiency in female mice treated with alkylating chemotherapy. Fertil Steril. 2013 Jun;99(7):2045-54.e3. doi: 10.1016/j.fertnstert.2013.01.135. Epub 2013 Feb 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Return of menses | Return of menses in patients with amenorrhea of at least 4 months | 6 months | |
Secondary | Pregnancy | Occurrence of pregnancy as diagnosed by positive serum B-hCG and/or ultrasound | 6 months | |
Secondary | serum Estradiol | Normalization of serum Estradiol as tested bi-weekly | 6 months | |
Secondary | serum Anti-mullarian Hormone (AMH) | Normalization of serum AMH in patients with AMH level less than 0.9 ng/mL | 6 months | |
Secondary | serum FSH | Normalization of serum FSH in patients with FSH level above 25 IU/L | 6 months | |
Secondary | Follicular growth | Growth of follicle to size at least 18 mm as monitored by transvaginal ultrasound | 6 months | |
Secondary | endometrial thickness | increase of endometrial thickness in women with thin endometrium (less then 8 mm) | 6 months |
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