Effect of Addition of Aromatase Inhibitor to Ovarian Stimulation Therapy in IVF Treatment
- Registration Number
- NCT02946684
- Lead Sponsor
- Sven O. Skouby
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 129
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lactose Monohydrate Placebo 2 tablets of placebo are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 IU of recFSH Letrozole 5mg Letrozole 2 tablets of 2,5mg Letrozole are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 IU of recFSH
- Primary Outcome Measures
Name Time Method Serum progesterone level Assessed during stimulation treatment on day before hCG injection (throughout the study completion, up to 3 years)
- Secondary Outcome Measures
Name Time Method Endometrial thickness in millimeters Assessed throughout the study completion, up to 3 years Clinical pregnancy rate 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. Total IU of Follicle Stimulating Hormone used per cycle. Assessed throughout study completion, up to 3 years Oocyte fertilization rate Assessed during stimulation treatment (throughout the study completion, up to 3 years Number and quality of embryos obtained, including rate of blastocyst formation. Assessed during stimulation treatment (throughout the study completion, up to 3 years Serum estradiol, testosterone and androstenedione levels 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. Number of follicles > 12 mm 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. 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 Biochemical pregnancy rate Assessed 2 weeks after embryo transfer following stimulation (throughout study completion, up to 3 years) Reported side effects 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. P and 17-hydroxyprogesterone (17-HP) Area Under the Curve. Assessed during stimulation treatment throughout the study completion, up to 3 years. Follicular fluid concentration of estradiol, testosterone, inhibin B and AMH levels Assessed during stimulation treatment (throughout the study completion, up to 3 years Proportion of oocytes resulting in top quality day 2, day 3 embryos or day 5/6 embryos according to validated morphological criteria. Assessed at day 2-3 after oocyte pick up following stimulation (throughout study completion, up to 3 years) Implantation rate Assessed during stimulation treatment (throughout the study completion, up to 3 years Morphokinetic parameters of embryo quality as measured using a Time Lapse analysis in centers employing this technology. Assessed from time of oocyte pick-up to embryo transfer following stimulation (throughout study completion, up to 3 years)
Trial Locations
- Locations (4)
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
Unit of Reproductive Medicine, Herlev Hospital
🇩🇰Herlev, Capital Region, Denmark