This project seeks to determine whether estradiol suppression achieved with adjuvant treatment with an aromatase inhibitor improves end-follicular and midluteal phase parameters during IVF. 128 patients will be randomized to either placebo or active treatment.
The aim of the study is to investigate whether the detrimental effects of ovarian stimulation on outcomes in fresh embryo transfer cycles be ameliorated by co-treatment with aromatase inhibitors? The research questions are: 1. Can the impact of ovarian stimulation on late follicular phase sex steroid levels (and hence endometrial receptivity) be mitigated by co-treatment with aromatase inhibitors during ovarian stimulation? 2. Does co-treatment with aromatase inhibitors 'normalize' the endocrinology of the midluteal phase
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
129
Unit of Reproductive Medicine, Herlev Hospital
Herlev, Capital Region, Denmark
Department of Fertility, Juliane Marie Centeret
Copenhagen, Capitol Region, Denmark
Clinic of Fertility, Hvidovre Hospital
Hvidovre, Capitol Region, Denmark
Clinic of Fertility, Holbæk Hospital
Holbæk, Region of Zealand, Denmark
Serum progesterone level
Time frame: Assessed during stimulation treatment on day before hCG injection (throughout the study completion, up to 3 years)
Serum estradiol, testosterone and androstenedione levels
Time frame: Assessed on stimulation day 5, day of hCG administration (or the day before), day 7 and 10 after hCG administration. Assessed throughout study completion, up to 3 years.
P and 17-hydroxyprogesterone (17-HP) Area Under the Curve.
Time frame: Assessed during stimulation treatment throughout the study completion, up to 3 years.
Follicular fluid concentration of estradiol, testosterone, inhibin B and AMH levels
Time frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years
Total IU of Follicle Stimulating Hormone used per cycle.
Time frame: Assessed throughout study completion, up to 3 years
Number of follicles > 12 mm
Time frame: Assessed in stimulated cycle on day of hCG administration or the day before (throughout the study completion), up to 3 years. Cycle length is between 21 and 35 days
Number of oocytes obtained oocytes obtained.
Time frame: Assessed in stimulated cycle at time of oocyte pick up after follicle aspiration (throughout the study completion, up to 3 years).Cycle length is between 21 and 35 days
Proportion of oocytes resulting in top quality day 2, day 3 embryos or day 5/6 embryos according to validated morphological criteria.
Time frame: Assessed at day 2-3 after oocyte pick up following stimulation (throughout study completion, up to 3 years)
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Oocyte fertilization rate
Time frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years
Number and quality of embryos obtained, including rate of blastocyst formation.
Time frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years
Endometrial thickness in millimeters
Time frame: Assessed throughout the study completion, up to 3 years
Implantation rate
Time frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years
Biochemical pregnancy rate
Time frame: Assessed 2 weeks after embryo transfer following stimulation (throughout study completion, up to 3 years)
Clinical pregnancy rate
Time frame: Pregnancy scan at gestational age week 7-8 (3-4 weeks after the positive hCG in serum). Assessed throughout study completion, up to 3 years.
Morphokinetic parameters of embryo quality as measured using a Time Lapse analysis in centers employing this technology.
Time frame: Assessed from time of oocyte pick-up to embryo transfer following stimulation (throughout study completion, up to 3 years)
Reported side effects
Time frame: From start of stimulation and administration of study medication to pregnancy scan week gestational age 7-8. Assessed throughout study completion, up to 3 years.