REDUCING THE IMPACT OF OVARIAN STIMULATION - THE RIOT PROJECT

INTERVENTION: Trade Name: Letrozol "Accord" Product Name: Letrozol Pharmaceutical Form: Capsule INN or Proposed INN: LETROZOLE CAS Number: 112809‐51‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Gastroenteral use CONDITION: Infertility ; MedDRA version: 18.1 Level: LLT Classification code 10016401 Term: Female infertility of other specified origin System Organ Class: 100000004872 ; MedDRA version: 18.1 Level: LLT Classification code 10025511 Term: Male infertility, unspecified System Organ Class: 100000004872 ; MedDRA version: 18.1 Level: LLT Classification code 10016403 Term: Female infertility of tubal origin System Organ Class: 100000004872 Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: This project seeks to determine whether estradiol suppression achieved with adjuvant treatment with an aromatase inhibitor improves luteal phase parameters during IVF. Primary end point(s): 1. Serum progesterone level on day of hCG; ; Secondary Objective: Oocyte fertilisation, embryo quality, implantantation, pregnancy rate Timepoint(s) of evaluation of this end point: Patient recruitment: March 2016 – March 2018; Data analysis: March 2018 – September 2018; Publication of results: September 2018 – March 2019; SECONDARY OUTCOME: Secondary end point(s): 1. 1. Serum E2, and testosterone (Tst) levels on Stimulation day 5, on the day of hCG administration (or the day before), day 7 after hCG administration and day 10 after hCG. ; ; 2. Area under the curve from day 4 to day 10 post hCG administration for, P and 17‐hydroxyprogesterone (17‐HP). ; ; ; 3. Follicular fluid E2, Tst, inhibin B and AMH levels ; ; 4. Total IU of FSH used per cycle. ; ; 5. Number of follicles > 12 mm on day of hCG (or the day before) and oocytes obtained. ; ; 6. Proportion of oocytes resulting in top quality day 2 (or day 3) embryos according to validated morphological criteria. ; ; 7. Oocyte fertilization rate ; ; 8. Number and quality of embryos obtained, including rate of blastocyst formation. ; ; 9. Endometrial thickness on day of hCG (or the day before) and day of embryo transfer. ; ; 10. Implantation rate, biochemical and ongoing pregnancy rate. ; ; 11. Reported side effects ; ; 12. Morphokinetic parameters of embryo quality as measured using a Time Lapse analysis in centers employing this technology. ; ; 13. Clinical pregnancy rate ; Timepoint(s) of evaluation of this end point: Patient recruitment: March 2016 – March 2018 ; Data analysis: March 2018 – September 2018 ; Publication of results: September 2018 – March 2019 ; INCLUSION CRITERIA: Medical indication for IVF treatment Antral follicle count (AFC) between 10 and 25 both included Age < 40 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 128 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range