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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005682-24 | EudraCT Number | ||
| H-15021850 | Other Identifier | Ethics Committee | |
| HGH-2016-045_04513 | Other Identifier | Danish Data Protection Board |
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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Hvidovre University Hospital | OTHER |
| Holbaek Sygehus | OTHER |
| Region Capital Denmark |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactose Monohydrate | Placebo Comparator | 2 tablets of placebo are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 IU of recFSH |
|
| Letrozole 5mg | Active Comparator | 2 tablets of 2,5mg Letrozole are administered daily from stimulation start to day before hCG as adjunctive therapy to 150 IU of recFSH |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Adjuvant therapy to recFSH during ovarian stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum progesterone level | Assessed during stimulation treatment on day before hCG injection (throughout the study completion, up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Sven O. Skouby, Professor | Unit of Reproductive Medicine, Herlev/Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Reproductive Medicine, Herlev Hospital | Herlev | Capital Region | 2730 | Denmark | ||
| Department of Fertility, Juliane Marie Centeret |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37699851 | Derived | Bulow NS, Warzecha AK, Nielsen MV, Andersen CY, Holt MD, Petersen MR, Sopa N, Zedeler A, Englund AL, Pinborg A, Grondahl ML, Skouby SO, Macklon NS. Impact of letrozole co-treatment during ovarian stimulation on oocyte yield, embryo development, and live birth rate in women with normal ovarian reserve: secondary outcomes from the RIOT trial. Hum Reprod. 2023 Nov 2;38(11):2154-2165. doi: 10.1093/humrep/dead182. | |
| 34792133 |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D047072 | Aromatase Inhibitors |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| OTHER |
| Copenhagen University Hospital, Denmark | OTHER |
| Zealand University Hospital | OTHER |
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| Placebo | Drug | Adjuvant therapy to recFSH during ovarian stimulation |
|
|
| 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. |
| Copenhagen |
| Capitol Region |
| 2100 |
| Denmark |
| Clinic of Fertility, Hvidovre Hospital | Hvidovre | Capitol Region | 2650 | Denmark |
| Clinic of Fertility, Holbæk Hospital | Holbæk | Region of Zealand | 4300 | Denmark |
| Derived |
| Bulow NS, Skouby SO, Warzecha AK, Udengaard H, Andersen CY, Holt MD, Grondahl ML, Nyboe Andersen A, Sopa N, Mikkelsen ALE, Pinborg A, Macklon NS. Impact of letrozole co-treatment during ovarian stimulation with gonadotrophins for IVF: a multicentre, randomized, double-blinded placebo-controlled trial. Hum Reprod. 2022 Jan 28;37(2):309-321. doi: 10.1093/humrep/deab249. |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |