Clinical trial
The Impact of Frozen - Thawed Blastocyst Morphological Development and Blastocoele Re-expansion on Clinical Pregnancy Outcome After One Controlled Ovarian Stimulation Cycle Using REKOVELLE®
Name
000317
Description
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.
Trial arms
Trial start
2018-09-01
Estimated PCD
2020-12-31
Trial end
2020-12-31
Status
Terminated
Treatment
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.
Arms:
REKOVELLE®
Size
362
Primary endpoint
Clinical pregnancy rate
7 weeks after each embryo transfer
Eligibility criteria
Inclusion Criteria:
* Patients undergoing elective single embryo transfer (e-SET) in a frozen embryo replacement (FER) treatment where the frozen blastocyst was obtained from an IVF or intracytoplasmic sperm injection (ICSI) cycle following controlled ovarian stimulation with REKOVELLE® .
* 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 any contraindication for treatment with REKOVELLE® for controlled ovarian stimulation.
* Patients with contraindication for undergoing assisted reproductive technologies (ART) such as an IVF or ICSI cycle.
* Oocyte donors.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 362, 'type': 'ACTUAL'}}
Updated at
2023-12-12
1 organization
Organization
Ferring Pharmaceuticals