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

NCT03697031 | Terminated

• 1 other identifier: 000317
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 1

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.

Conditions

Controlled Ovarian Stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Cumulative clinical pregnancy rate

  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®

  At the day of the consultation visit where the daily dose of REKOVELLE® is decided

• Daily dose of REKOVELLE® administered

  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

Study Arms (1)

REKOVELLE®

Follitropin Delta

Drug: Follitropin Delta

Interventions

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.

REKOVELLE®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Ciconia, VivaNeo (there may be other sites in this country)

Højbjerg, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37835035 RESULT

MeSH Terms

Interventions

follitropin delta

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: October 5, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 12, 2023

Record last verified: 2021-10

Locations

DK (1)