Clinical trial NCT03697031: Impact of Blastocyst Morphological Development and Blastocoele Re-expansion on Pregnancy Outcome After Using REKOVELLE®
Official title: The Impact of Frozen - Thawed Blastocyst Morphological Development and Blastocoele Re-expansion on Clinical Pregnancy Outcome After One Controlled Ovarian Stimulation Cycle Using REKOVELLE®
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Controlled Ovarian Stimulation
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-10-05
Enrollment: 362
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


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.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 7 weeks after each embryo transfer
Secondary outcomes:
measure: Cumulative clinical pregnancy rate
timeFrame: Up to 24 months
measure: Positive βhCG result (blood or urinary pregnancy test)
timeFrame: Up to 24 months
measure: Use of the algorithm-based individualized dosing regimen with REKOVELLE®
timeFrame: At the day of the consultation visit where the daily dose of REKOVELLE® is decided
measure: Daily dose of REKOVELLE® administered
timeFrame: From day 1 up to day 20 of REKOVELLE® stimulation
measure: Number of days of treatment with REKOVELLE®
timeFrame: From day 1 up to day 20 of REKOVELLE® stimulation
measure: Day of REKOVELLE® stimulation start
timeFrame: At the day of the first REKOVELLE® injection during the ovarian stimulation treatment
measure: Day of REKOVELLE® stimulation end
timeFrame: At the day of the last REKOVELLE® injection during the ovarian stimulation treatment
measure: Any deviation in REKOVELLE® administration
timeFrame: From day 1 up to day 20 of REKOVELLE® stimulation
Other outcomes:
Locations:
city: Højbjerg
country: Denmark
facility: Ciconia, VivaNeo (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
citation: 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.