Dual Trigger for Elective Fertility Preservatio
- Conditions
- This study is a randomized controlled, superiority trial comparing the number of MII oocytes following final follicle maturation with dual trigger (250 µg rhCG + 0.2mg Triptorelin) or GnRH-a trigger (0.2mg Triptorelin) in women undergoing elective fertility preservation.Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2021-002467-22-ES
- Lead Sponsor
- Fundacion Santiago Dexeus Font
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 100
•AFC < 20
•Anti-Mullerian hormone (AMH) = 3ng/ml (AMH result of up to one year will be valid)
•Age = 40 years
•BMI > 18 and < 30 kg/m2
•Willing to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Medically indicated fertility preservation
•AFC = 20
•Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria
•FSH = 20
•History of untreated autoimmune, endocrine or metabolic disorders
•Contraindication for hormonal treatment
•Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method