Impact of Blastocyst Morphological Development and Blastocoele Re-expansion on Pregnancy Outcome After Using REKOVELLE®

• Cumulative clinical pregnancy rate[ Time Frame: Up to 24 months ]
  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.
• Positive βhCG result (blood or urinary pregnancy test)[ Time Frame: Up to 24 months ]
• Use of the algorithm-based individualized dosing regimen with REKOVELLE®[ Time Frame: At the day of the consultation visit where the daily dose of REKOVELLE® is decided ]
  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.
• Daily dose of REKOVELLE® administered[ Time Frame: From day 1 up to day 20 of REKOVELLE® stimulation ]
  Daily dose of REKOVELLE® in micrograms is recorded.
• Number of days of treatment with REKOVELLE®[ Time Frame: From day 1 up to day 20 of REKOVELLE® stimulation ]
• Day of REKOVELLE® stimulation start[ Time Frame: At the day of the first REKOVELLE® injection during the ovarian stimulation treatment ]
  The time point of the start of the stimulation is decided at the discretion of the investigator.
• Day of REKOVELLE® stimulation end[ Time Frame: At the day of the last REKOVELLE® injection during the ovarian stimulation treatment ]
  The time point of the end of the stimulation is decided at the discretion of the investigator.
• Any deviation in REKOVELLE® administration[ Time Frame: From day 1 up to day 20 of REKOVELLE® stimulation ]
  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.

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.

• Drug: 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.

• : REKOVELLE®
  Follitropin Delta