low ovarian reserve MedDRA version: 20.0 Level: LLT Classification code 10036602 Term: Premature ovarian failure System Organ Class: 100000004872
Conditions
Interventions
Trade Name: DANATROL
Pharmaceutical Form: Capsule
INN or Proposed INN: DANAZOL
CAS Number: 17230-88-5
Other descriptive name: DANAZOL
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
IVIRMA MADRID
Eligibility
Sex/Gender
All
Inclusion criteria
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 decision to use contraception methods different to sexual hormones, such as the use of condoms, during the treatment with Danazol. -female, aged 30 to 45 years old. -In good general health as evidenced by medical history or diagnosed with body mass index between 18 and 30Kg/m2. -Women with normal (AMH value must be equal or higher than 2ng/ml) or compromised ovarian reserve (defined as AMH =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Pregnancy or 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 thromboembolic diseases. -Known allergic reactions to components of the study product (cornstarch and lactose). -Having received ovulation induction drugs within one month before the inclusion 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 inclusion in the present study that could affect its objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Define a pilot study to determine telomeric length distribution in granulosa cells to evaluate if telomerase reactivation via sexual steroids (DANAZOL), in patients with low ovarian reserve, is feasible.;Secondary Objective: -Describe telomere length and accumulation of short telomeres in blood. -Determine if there is a correlation between telomeric factors in blood and granulosa cells in order to find new biomarkers for early detection of premature low ovarian reserve. -Determination of the DNA damage inside the cell nucleus and the percentage of activation of proteins involved in senescence. -Study of the status of telomere protection by shelterins in blood and GC. -Study the beneficial effects of steroid treatment on fertilization parameters -Examination of the ovarian volume and reserve before and after treatment with sexual steroids and compared with normal ovarian reserve patients. -Analysis of the total number of oocytes retrieved (particularly MII oocytes) after induction of ovulation in all groups. -Analysis of the quality of embryos (morphology of embryos), the implantation rate and the clinical pregnancy rate . -Assessment and recording of adverse events;Primary end point(s): Reduction in the percentage of dysfunctional telomeres in Granulosa Cells.;Timepoint(s) of evaluation of this end point: After Eighth visit (36 h +/- 2h post induction) for women with low ovarian reserve and Fifth visit for woman with normal ovarian reserve | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Accumulation of short telomeres,telomerase activity,DNA damage measurements, other telomeric factors,activation of factors. 2-Ovarian reserve and volumen 3- Oocytes collection 4- Quality of the embryos obtained. 5-Pregnancy results 6- Safety assessment;Timepoint(s) of evaluation of this end point: The evaluation will be done: 1-Accumulation of short telomeres,telomerase activity,DNA damage measurements, other telomeric factors,activation of factors. After V5 and V10 for women with low ovarian reserve and V5 and V8 for woman with normal ovarian reserve. 2-Ovarian reserve and volumen. V7 for women with low ovarian reserve and V4 for woman with normal ovarian reserve. 3- Oocytes collection.V8 for women with low ovarian reserve and V5 for woman with normal ovarian reserve. 4- Quality of the embryos obtained. V9 for women with low ovarian reserve and V6 for woman with normal ovarian reserve. 5-Pregnancy results. V10 and V11 for women with low ovarian reserve and V7 and V8 for woman with normal ovarian reserve. 6- Safety assessment, during all study. | — |
Countries
Spain
Contacts
Public ContactMaría Elisa Varela Sanz
IVIRMA
Outcome results
None listed