Infertility MedDRA version: 20.0 Level: LLT Classification code 10016401 Term: Female infertility of other specified origin System Organ Class: 100000004872 MedDRA version: 20.0 Level: LLT Classification code 10025511 Term: Male infertility, unspecified System Organ Class: 100000004872 MedDRA version: 20.0 Level: LLT Classification code 10016403 Term: Female infertility of tubal origin System Organ Class: 100000004872
Conditions
Interventions
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
C
Sponsors
Sven Olaf Skouby, Professor, MD, DMSc. Unit of Reproductive Medicine, Herlev/Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Indication for IVF/ICSI treatment Eligible for IVF/ICSI treatment according to local criteria IVF/ICSI treatment with single embryo transfer Regular cycles 21-35 days (both included) Age =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any contraindication for IVF/ICSI treatment according to local criteria Previous stimulation for IVF/ICSI with < 4 oocytes obtained PCOS Undergoing IVF/ICSI for the purpose of fertility preservation Allergy towards study drug After inclusion the participants will be excluded from further participation in the trial in case of ? Withdrawal of consent ? Lack of compliance with study medication ? Medical complications arising from IVF treatment that would require the cycle to be terminated on clinical grounds ? Serious adverse event or reaction including severe allergy to study drug or developing an excessive response to ovarian hyperstimulation in the follicular phase for which termination of all medication was required. ? Specific adverse reactions to study drug: severe degree of hot flushes, severe degree of nausea/vomiting, severe degree of muscle and joint pain. Participants who are withdrawn from the study will be replaced by inclusion of new participants. Should the study participant present with ovarian cyst or inadequate endometrium thickness according to local guidelines on the initial ultrasound scan, the participant will be managed according to local clinical policies. The participant can be randomized when she is considered ready to commence ovarian stimulation according to local protocols. In case of a low response to stimulation resulting in cancellation of the cycle before oocyte retrieval, or when no embryos are available for transfer, the participant will be withdrawn from further participation. Both instances will be addressed in the report of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This project seeks to determine whether estradiol suppression achieved with adjuvant treatment with an aromatase inhibitor improves luteal phase parameters during IVF.;Secondary Objective: Oocyte fertilisation, embryo quality, implantantation, pregnancy rate;Primary end point(s): 1. Serum progesterone level on day of hCG ;Timepoint(s) of evaluation of this end point: Patient recruitment: November – August 2018 Data analysis: March 2018 – March 2019 Publication of results: December 2018 – March 2019 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Area under the curve from day 4 to day 10 post hCG administration for P and 17-hydroxyprogesterone (17-HP). 2. Serum E2, androstenedione and testosterone (T) levels on Stimulation day 5, on the day of hCG administration (or the day before), day of oocyte pick up (OPU), day 7 after hCG administration and day 10 after hCG. 3. Follicular fluid E2, androstenedione, T, 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 (viable intra-uterine pregnancy recorded at week 7-8 ultrasound). 11. Reported side effects 12. Morphometric/kinetic markers of embryo quality ;Timepoint(s) of evaluation of this end point: Patient recruitment: November 2016 – March 2018 Data analysis: March 2018 – September 2018 Publication of results: September 2018 – March 2019 | — |
Countries
Denmark
Contacts
Public ContactUnit of Reproductive Medicine
Sven Olaf Skouby, Professor, MD, DMSc. Unit of Reproductive Medicine, Herlev Hospital
Outcome results
None listed