Ovarian Reserve Clinical Trial
Official title:
Effects of Telomerase Reactivation With Danazol in Ovarian Function.
Verified date | August 2022 |
Source | IVI Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project explores the implication of the telomere pathway in ovarian premature and regular aging. Telomere length and maintenance underlie several biological processes such cancer, aging, human diseases and the biology of stem cells. The reactivation of telomerase should lead to a rejuvenation of the ovarian tissue and the improvement of fertility. The correlation of telomeric factors in blood and granulosa cells will be studied with the aim of finding telomeric biomarkers of ovarian aging.
Status | Completed |
Enrollment | 19 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 45 Years |
Eligibility | Inclusion Criteria: - Provide signed and dated informed consent form. - Willing to comply with all study procedures and be available for the duration of the study. This include the decisión to use contraception methods different to sexual hormones, such as the use of condoms, during the treatment with Danazol. - In good general health as evidenced by medical history or diagnosed with body mass index between 18 and 30 kg/m2. - Women with normal (AMH valued must be equal or higher tan 2ng/ml) or compromised ovarian reserve (defined as AMH < 2 ng/ml) - Not having had any steroid hormones for one month. Exclusion Criteria: - Pregnancy o lactation. - Taking other sexual hormones. - Women with diseases in heart, liver or kidney or tumors which depend on male sexual hormones or hormone-dependent tumour. - Women taking anticonvulsants, medicaments for diabetes, anticoagulants and anti-hypertension: ciclosporin and tacrolimus and other steroids and statins. - Women suffering irregular genital bleeding or with thrombus or thromboembolicdiseases. - Known allergic reactions to components of the study product (cornstarch and lactose). - Having received ovulation induction drugs within one month before the inclusión in the study. - Anything that would place the individual at increased risk or preclude the individual´s full compliance with or completion of the study. - Simultaneous participation in another clinical trial or previous participation in this study. - Participation in another clinical study 2 months before inclusión in the present study that could affect its objectives. |
Country | Name | City | State |
---|---|---|---|
Spain | Ivirma Madrid | Madrid |
Lead Sponsor | Collaborator |
---|---|
IVI Madrid |
Spain,
Armanios MY, Chen JJ, Cogan JD, Alder JK, Ingersoll RG, Markin C, Lawson WE, Xie M, Vulto I, Phillips JA 3rd, Lansdorp PM, Greider CW, Loyd JE. Telomerase mutations in families with idiopathic pulmonary fibrosis. N Engl J Med. 2007 Mar 29;356(13):1317-26. — View Citation
Bernardes de Jesus B, Vera E, Schneeberger K, Tejera AM, Ayuso E, Bosch F, Blasco MA. Telomerase gene therapy in adult and old mice delays aging and increases longevity without increasing cancer. EMBO Mol Med. 2012 Aug;4(8):691-704. doi: 10.1002/emmm.201200245. Epub 2012 May 15. — View Citation
Blasco MA, Lee HW, Hande MP, Samper E, Lansdorp PM, DePinho RA, Greider CW. Telomere shortening and tumor formation by mouse cells lacking telomerase RNA. Cell. 1997 Oct 3;91(1):25-34. — View Citation
Blasco MA. Telomeres and human disease: ageing, cancer and beyond. Nat Rev Genet. 2005 Aug;6(8):611-22. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Telomere length in granulosa cells | Measured in arbitrary units of fluorescence (a.u.) from 0 to 255 gray intensity (8bit) or Kb (continuous variable). Below 3 kb are considered critically short telomeres in humans. | The evaluation of the main assessment criterion will be done both after eighth visit (36 hours post induction) for women with low ovarian reserve and fifth visit for woman with normal ovarian reserve | |
Secondary | Accumulation of short telomeres | Measured in arbitrary units of fluorescence (a.u.) from 0 to 255 gray intensity (8bit) or Kb (continuous variable). Below 3 kb are considered critically short telomeres in humans. | Through study completion, an average of 1 year | |
Secondary | Telomerase activity | Product of PCR amplification, run in acrylamide gels and quantified as band intensity (continuous variable) | Through study completion, an average of 1 year | |
Secondary | DNA damage measurement | If damage is positive, then different foci should be apparent in the nucleus of the cell. The number of foci present in the nuclei of at least 100 cells will be counted. If there is DNA damage at telomeres, then yH2AX or 53BPI foci will colocalize with telomeres (labelled with anti TRF1 antibody). Spots will be counted (continuous variable). | Through study completion, an average of 1 year | |
Secondary | Other telomeric factors. | The mRNA expression levels of the telomerase gene and the shelterins, which are involved in telomere lengthening and protection, will be measured by qPCR. (continuous variable). | Through study completion, an average of 1 year |
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