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Effect of Addition of Aromatase Inhibitor to Ovarian Stimulation Therapy in IVF Treatment (RIOT-A)

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ClinicalTrials.gov Identifier: NCT02946684
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : February 6, 2019
Sponsor:
Collaborators:
Rigshospitalet, Denmark
Hvidovre University Hospital
Holbaek Sygehus
Region Capital Denmark
Copenhagen University Hospital, Denmark
Zealand University Hospital
Information provided by (Responsible Party):
Sven O. Skouby, Herlev Hospital

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
Infertility Drug: Letrozole Drug: Placebo 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:

  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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing the Impact of Ovarian Stimulation - The RIOT Project. Study RIOT-A: The Role of Aromatase Inhibitor in Reducing the Detrimental Effects of Ovarian Stimulation to Optimize Outcomes in Fresh Embryo Transfer Cycles
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

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 Name: Lactose Monohydrate

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 Name: Aromatase Inhibitor




Primary Outcome Measures :
  1. Serum progesterone level [ Time Frame: Assessed during stimulation treatment on day before hCG injection (throughout the study completion, up to 3 years) ]

Secondary Outcome Measures :
  1. 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. ]
  2. P and 17-hydroxyprogesterone (17-HP) Area Under the Curve. [ Time Frame: Assessed during stimulation treatment throughout the study completion, up to 3 years. ]
  3. 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 ]
  4. Total IU of Follicle Stimulating Hormone used per cycle. [ Time Frame: Assessed throughout study completion, up to 3 years ]
  5. 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 ]
  6. 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 ]
  7. 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) ]
  8. Oocyte fertilization rate [ Time Frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years ]
  9. 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 ]
  10. Endometrial thickness in millimeters [ Time Frame: Assessed throughout the study completion, up to 3 years ]
  11. Implantation rate [ Time Frame: Assessed during stimulation treatment (throughout the study completion, up to 3 years ]
  12. Biochemical pregnancy rate [ Time Frame: Assessed 2 weeks after embryo transfer following stimulation (throughout study completion, up to 3 years) ]
  13. 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. ]
  14. 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) ]
  15. 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. ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946684


Locations
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Denmark
Unit of Reproductive Medicine, Herlev Hospital
Herlev, Capital Region, Denmark, 2730
Department of Fertility, Juliane Marie Centeret
Copenhagen, Capitol Region, Denmark, 2100
Clinic of Fertility, Hvidovre Hospital
Hvidovre, Capitol Region, Denmark, 2650
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
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Principal Investigator: Sven O. Skouby, Professor Unit of Reproductive Medicine, Herlev/Gentofte Hospital

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Responsible Party: Sven O. Skouby, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02946684     History of Changes
Other Study ID Numbers: RIOTA2015
2015-005682-24 ( EudraCT Number )
H-15021850 ( Other Identifier: Ethics Committee )
HGH-2016-045_04513 ( Other Identifier: Danish Data Protection Board )
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Letrozole
Aromatase Inhibitors
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs