Impact of Blastocyst Morphological Development and Blastocoele Re-expansion on Pregnancy Outcome After Using REKOVELLE®
NCT ID: NCT03697031
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
362 participants
OBSERVATIONAL
2018-09-01
2020-12-31
Brief Summary
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The ovarian stimulation protocol with REKOVELLE®, a new rFSH prescribed for ovarian stimulation, is individualised with a dosing regimen that is based on two parameters: the body weight and the level of a hormone, the anti-Müllerian hormone, (AMH), a parameter used to predict how the ovaries will respond to the ovarian stimulation.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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REKOVELLE®
Follitropin Delta
Follitropin Delta
The Intervention (solution for injection) is delivered with an injection pen. For women with AMH \<15 pmol/L the daily dose is 12 micrograms, irrespective of body weight. For women with AMH ≥15 pmol/L the daily dose decreases from 0.19 to 0.10 micrograms/kg by increasing AMH concentration. The maximum daily dose for the first treatment cycle is 12 micrograms.
For subsequent treatment cycles, the daily dose of REKOVELLE® should be maintained or modified according to the patient's ovarian response in the previous cycle. Based on the ovarian hypo/hyper-response in the previous cycle, the daily dose in the subsequent cycle should be increased (by 25% or 50%) or decreased (by 20% or 33%). The maximum daily dose is 24 micrograms.
Interventions
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Follitropin Delta
The Intervention (solution for injection) is delivered with an injection pen. For women with AMH \<15 pmol/L the daily dose is 12 micrograms, irrespective of body weight. For women with AMH ≥15 pmol/L the daily dose decreases from 0.19 to 0.10 micrograms/kg by increasing AMH concentration. The maximum daily dose for the first treatment cycle is 12 micrograms.
For subsequent treatment cycles, the daily dose of REKOVELLE® should be maintained or modified according to the patient's ovarian response in the previous cycle. Based on the ovarian hypo/hyper-response in the previous cycle, the daily dose in the subsequent cycle should be increased (by 25% or 50%) or decreased (by 20% or 33%). The maximum daily dose is 24 micrograms.
Eligibility Criteria
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Inclusion Criteria
* Women are prescribed REKOVELLE® for their IVF or ICSI according to the approved label.
* Morphological measurements and clinical outcomes are available for the fresh embryos obtained from the IVF or ICSI cycle.
* Willing and able to understand Danish or English patient information.
* Willingness and ability to provide written informed consent.
Exclusion Criteria
* Patients with contraindication for undergoing assisted reproductive technologies (ART) such as an IVF or ICSI cycle.
* Oocyte donors.
18 Years
45 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Ciconia, VivaNeo (there may be other sites in this country)
Højbjerg, , Denmark
Countries
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References
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Gabrielsen A, Iversen LH, Fedder J, Eskildsen TV, Englund AL, Hansen SR, Pinton P. Pre-Vitrification and Post-Warming Variables of Vitrified-Warmed Blastocysts That Are Predictable for Implantation. J Clin Med. 2023 Oct 6;12(19):6389. doi: 10.3390/jcm12196389.
Other Identifiers
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000317
Identifier Type: -
Identifier Source: org_study_id