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

Terminated

• Conditions: Controlled Ovarian Stimulation
• Interventions: Drug: Follitropin Delta

• Registration Number: NCT03697031
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-05
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 362

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
REKOVELLE®	Follitropin Delta	Follitropin Delta

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	7 weeks after each embryo transfer	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.

Secondary Outcome Measures

Name	Time	Method
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	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.
Day of REKOVELLE® stimulation start	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.
Any deviation in REKOVELLE® administration	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.
Daily dose of REKOVELLE® administered	From day 1 up to day 20 of REKOVELLE® stimulation	Daily dose of REKOVELLE® in micrograms is recorded.
Day of REKOVELLE® stimulation end	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.
Cumulative clinical pregnancy rate	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)	Up to 24 months
Number of days of treatment with REKOVELLE®	From day 1 up to day 20 of REKOVELLE® stimulation

Trial Locations

Locations (1)

Ciconia, VivaNeo (there may be other sites in this country); 🇩🇰 Højbjerg, Denmark