RIOT-A: Effect of Addition of Aromatase Inhibitor to Ovarian Stimulation Therapy in IVF Treatment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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:
-
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?
-
Does co-treatment with aromatase inhibitors 'normalize' the endocrinology of the midluteal phase
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Lactose Monohydrate 2 tablets of placebo are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 IU of recFSH |
Drug: Placebo
Adjuvant therapy to recFSH during ovarian stimulation
Other Names:
|
| Active Comparator: Letrozole 5mg 2 tablets of 2,5mg Letrozole are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 IU of recFSH |
Drug: Letrozole
Adjuvant therapy to recFSH during ovarian stimulation
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Serum progesterone level [Assessed during stimulation treatment on day before hCG injection (throughout the study completion, up to 3 years)]
Secondary Outcome Measures
- 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.]
- 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]
- Total IU of Follicle Stimulating Hormone used per cycle. [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]
- 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)]
- 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]
- Endometrial thickness in millimeters [Assessed throughout the study completion, up to 3 years]
- Implantation rate [Assessed during stimulation treatment (throughout the study completion, up to 3 years]
- Biochemical pregnancy rate [Assessed 2 weeks after embryo transfer following stimulation (throughout 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.]
- 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)]
- 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.]
Eligibility Criteria
Criteria
INCLUSION CRITERIA
-
Indication for IVF/ICSI treatment
-
Eligible for IVF/ICSI treatment according to local criteria
-
Regular cycles 21-35 days (both included)
-
Age < 40
-
AMH 8- 32 (both included)
-
Written consent
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Unit of Reproductive Medicine, Herlev Hospital | Herlev | Capital Region | Denmark | 2730 |
| 2 | Department of Fertility, Juliane Marie Centeret | Copenhagen | Capitol Region | Denmark | 2100 |
| 3 | Clinic of Fertility, Hvidovre Hospital | Hvidovre | Capitol Region | Denmark | 2650 |
| 4 | Clinic of Fertility, Holbæk Hospital | Holbæk | Region Of Zealand | Denmark | 4300 |
Sponsors and Collaborators
- Sven O. Skouby
- Rigshospitalet, Denmark
- Hvidovre University Hospital
- Holbaek Sygehus
- Region Capital Denmark
- Copenhagen University Hospital, Denmark
- Zealand University Hospital
Investigators
- Principal Investigator: Sven O. Skouby, Professor, Unit of Reproductive Medicine, Herlev/Gentofte Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RIOTA2015
- 2015-005682-24
- H-15021850
- HGH-2016-045_04513