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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 14, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

September 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical pregnancy rate[ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

The Impact of Frozen - Thawed Blastocyst Morphological Development and Blastocoele Re-expansion on Clinical Pregnancy Outcome After One Controlled Ovarian Stimulation Cycle Using REKOVELLE®

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

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

: REKOVELLE®
Follitropin Delta

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1500

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 2020

Estimated Primary Completion Date

September 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Denmark

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Ferring Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Clinical Development Support Ferring Pharmaceuticals

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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