Comparison of two different drug protocols for ovarian stimulation in women with low egg reserve undergoing first attempt of in vitro fertilizatio
- Conditions
- response to ovarian stimulation in women with reduced ovarian reserve undergoing first cycle of in vitro fertilisaion.MedDRA version: 17.0Level: PTClassification code 10056204Term: In vitro fertilisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2012-004824-39-GB
- Lead Sponsor
- IVERSITY HOSPITALS OF LEICESTER NHS TRUST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 4
• Women 23-39 years, with body mass index (BMI) of 19-30 Kg/m2, who are ready to start their first IVF treatment cycle with or without intracytoplasmic sperm injection (ICSI) and who have AMH between 3.08-21.97 pmol/L and day 2-4 serum FSH <15 IU/L. (These AMH levels are compatible with reduced ovarian reserve on Gen II assay results).
• All women will have 2 ovaries identified on a previous scan.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
• Previous controlled ovarian stimulation for IVF
• Day 2-4 serum FSH levels = 15 iu/L
• AMH > 21.97 or < 3.08 pmol/L
• Known allergies to study medications
• Recognised endocrine abnormalities of the hypothalamic pituitary axis such as hypogonadism and hyperprolactinaemia
• Unsuitable for IVF/ICSI on welfare of the child assessment
• Concurrent participation in another drug trial
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