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Permanently terminated due to halt of recruitment due to COVID-19 pandemic
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The purpose of this observational study is to examine the development and appearance of embryos before and after freezing following a single controlled ovarian stimulation cycle using REKOVELLE® (follitropin delta) as the recombinant follicular stimulating hormone (rFSH) for controlled ovarian stimulation. The primary objective of the study is to examine how specific factors of embryo development or appearance are related to the chance of becoming pregnant.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REKOVELLE® | Follitropin Delta |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follitropin Delta | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Clinical pregnancy is defined as at least one intrauterine gestational sac with fetal heart beat at week 7, from frozen thawed blastocysts. The correlation between morphological parameters (blastocyst score, timelapse score, blastocoele re-expansion) and clinical pregnancy rate will be assessed. | 7 weeks after each embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative clinical pregnancy rate | The cumulative clinical pregnancy rate will be calculated based on all participants included in the study and all clinical pregnancies recorded from fresh and frozen-thawed blastocyst transfers as the fraction of participants with at least one positive clinical pregnancy. The cumulative pregnancy rate will be plotted versus transfer number and versus time from start of REKOVELLE® treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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The study aims to enroll between 1200 and 1500 cycles which is estimated to be sufficient for observing 616 single frozen-thawed blastocyst transfers. Patients can contribute data from one or more frozen-thawed blastocyst transfers. Further, the patient cohort will be recruited among the patient population of 8-10 public and private in vitro fertilization (IVF) clinics in Denmark.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ciconia, VivaNeo (there may be other sites in this country) | Højbjerg | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37835035 | Result | 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. |
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| ID | Term |
|---|---|
| C000620228 | follitropin delta |
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|
| Up to 24 months |
| Positive βhCG result (blood or urinary pregnancy test) | Up to 24 months |
| Use of the algorithm-based individualized dosing regimen with REKOVELLE® | Use of the Ferring developed dosing app for the daily dose calculation. The daily dose is calculated with body weight in kilograms or pounds and AMH serum level in pmoL/L or ng/ml to define the daily dose of REKOVELLE® in micrograms. | At the day of the consultation visit where the daily dose of REKOVELLE® is decided |
| Daily dose of REKOVELLE® administered | Daily dose of REKOVELLE® in micrograms is recorded. | From day 1 up to day 20 of REKOVELLE® stimulation |
| Number of days of treatment with REKOVELLE® | From day 1 up to day 20 of REKOVELLE® stimulation |
| Day of REKOVELLE® stimulation start | The time point of the start of the stimulation is decided at the discretion of the investigator. | At the day of the first REKOVELLE® injection during the ovarian stimulation treatment |
| Day of REKOVELLE® stimulation end | The time point of the end of the stimulation is decided at the discretion of the investigator. | At the day of the last REKOVELLE® injection during the ovarian stimulation treatment |
| Any deviation in REKOVELLE® administration | REKOVELLE® should be used according to the approved label, any possible deviations such as different starting dose or dose adjustment during stimulation will be recorded and analyzed. | From day 1 up to day 20 of REKOVELLE® stimulation |