Ovarian stimulation in oocyte donation MedDRA version: 20.0 Level: LLT Classification code 10071130 Term: Controlled ovarian stimulation System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10072100 Term: Egg donor System Organ Class: 100000004869
Conditions
Interventions
Trade Name: Letrozol "Accord"
Product Name: Letrozol
Product Code: L02BG04
Pharmaceutical Form: Tablet
INN or Proposed INN: LETROZOLE
CAS Number: 112809-51-5
Sponsors
Nicholas Stephen Macklon, Professor, MD, PhD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Meet the clinical criteria for acceptance as oocyte donors Regular ovulatory cycle of 26-30 days. Age: = 35 years (the age limit for donating eggs in Denmark) Written consent 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 26 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contraindications for ovarian stimulation or OPU according to local guidelines PCOS Allergy towards study drug Exclusion of patients after earlier inclusion in the study in case of - Patient withdrawal of consent - Lack of compliance with medication - Medical complications arising from IVF treatment that requires the cycle to be terminated - Serious adverse event (SAE) or serious adverse reaction (SAR) including severe allergy to study drug. - Specific adverse reactions to study drug: severe degree of hot flushed, severe degree of nausea/vomiting, severe diarrhea, severe degree of muscle and joint pain. In case of exclusion of a patient after earlier inclusion in the study, a new patient will be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The goal of the trial is to determine wheather co-treatment with aromatase inhibitor in ovarian stimulation in egg donors normalize the length of the unsupported luteal phase, reduce the endometrium thickness, positively modulate endocrine markers of luteal phase quality and endometrial markers of receptivity.;Secondary Objective: Not applicable;Primary end point(s): Difference in lengths (days until bleeding) of the luteal phase between interventions group and controls. ;Timepoint(s) of evaluation of this end point: Patients will start bleeding (menstruation) within two weeks after oocyte pickup. Patients will registry that date. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in established endometrial tissue and secretion markers of endometrial receptivity between intervention group and controls. Differences in the area under the curve for plasma E2, P, LH and FSH levels from day of OPU until day 14 post OPU between intervention group and controls. Difference in endometrium thickness 7 days post OPU between intervention group and controls. ;Timepoint(s) of evaluation of this end point: Difference in established endometrial tissue and secretion markers of endometrial receptivity between intervention group and controls: Endometrial secretion sample 7 days after oocyte pickup. Differences in the area under the curve for plasma E2, P, LH and FSH levels from day of OPU until day 14 post OPU between intervention group and controls: Blood Collection on day of oocyte pick up, 7 days after and 14 days after oocyte pick up. Difference in endometrium thickness 7 days post OPU between intervention group and controls: uterine ultrasound 7 days after oocyte pickup. | — |
Countries
Denmark
Contacts
Public ContactUnit of Reproductive Medicine
Nichohlas Stephen Macklon, Professor, MD, PhD. Unit of Reproductive Medicine
Outcome results
None listed