Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND) (BEYOND)

December 1, 2023 updated by: Ferring Pharmaceuticals

A Randomised, Controlled, Open Label, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of Individualised FE 999049 (Follitropin Delta) Dosing, Using a Long GnRH Agonist Protocol and a GnRH Antagonist Protocol in Women Undergoing Controlled Ovarian Stimulation

To compare the efficacy and safety of FE 999049 (follitropin delta) and its personalized dosing algorithm in controlled ovarian stimulation for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) using a long gonadotropin-releasing hormone (GnRH) agonist protocol versus a short GnRH antagonist protocol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
437

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Dobl, Austria
        • Das Kinderwunsch Institut Schenk GmbH
      • Linz, Austria
        • Kepler University Hospital Linz
      • Vienna, Austria
        • Kinderwunschzentrum Goldenes Kreuz Privatklinik
  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet
  • Israel
      • Hadera, Israel
        • Hillel Yafe Medical Center
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
      • Petah tikva, Israel
        • Beilinson Hospital Rabin Medical Center
      • Tel Aviv, Israel
        • Sourasky Medical Center
  • Italy
      • Bologna, Italy
        • Dipartimento della Donna, del bambino e delle malattie urologiche
      • Roma, Italy
        • European Hospital
  • Netherlands
      • Tilburg, Netherlands
        • St. Elisabeth Ziekenhuis
      • Zwolle, Netherlands
        • Isala Fertility Center
  • Norway
      • Oslo, Norway
        • Oslo University Hospital
      • Porsgrunn, Norway
        • Sykehuset Telemark HF
      • Trondheim, Norway
        • Medicus AS
  • Switzerland
      • Zürich, Switzerland
        • Gyn-A.R.T. AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infertile women aged 18-40 undergoing their first IVF/ICSI cycle that are in good physical and mental health and that have been diagnosed with problems in the fallopian tubes, mild endometriosis or have partners with decreased sperm quality.
  • The participants must have a regular menstrual cycle, a normal uterus and 2 normal ovaries.
  • The allowed body mass index is 17.5-32 Kg/m^2.

Exclusion Criteria:

  • Women with very high ovarian reserve, strong preference for either treatment, severe endometriosis, history of repeated miscarriage, couples with known problems in the chromosomes, history or high risk of producing blood cloths, women known to have chronic diseases, women recently participating in trials with non-registered drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FE 999049 + GnRH agonist (GONAPEPTYL)
Drug: FE 999049 + GnRH agonist (GONAPEPTYL)
Pre-filled injection pen
Active Comparator: FE 999049 + GnRH antagonist (CETROTIDE)
Drug: FE 999049 + GnRH antagonist (CETROTIDE)
Powder and solvent for solution for injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Oocytes Retrieved
Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation)
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
On day of oocyte retrieval (up to 22 days after start of stimulation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response
Time Frame: At end-of-stimulation (up to 20 days)
For each participant, the reason for cycle cancellation was recorded
At end-of-stimulation (up to 20 days)
Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame: At end of transfer (up to 4 weeks)
For each participant, the reason for blastocyst transfer cancellation was recorded.
At end of transfer (up to 4 weeks)
Number of Follicles
Time Frame: On stimulation day 6 and at end-of-stimulation (up to 20 days)
The total number of follicles and the number of follicles per size category will be reported
On stimulation day 6 and at end-of-stimulation (up to 20 days)
Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation)
Grouped according to number of oocytes
On day of oocyte retrieval (up to 22 days after start of stimulation)
Number of Metaphase II Oocytes
Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation)
Only applicable for those inseminated using ICSI
On day of oocyte retrieval (up to 22 days after start of stimulation)
Fertilization Rate
Time Frame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Measured by the number of pronuclei. Fertilized oocytes with 2 pronuclei were regarded as correctly fertilized
On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Number of Embryos
Time Frame: On day 3 after oocyte retrieval (up to 25 days after start of stimulation)
The number of embryos (total and good-quality) was reported. Embryo quality is determined by combined assessment of cleavage stage (number of blastomeres/compaction status) and embryo morphology parameters
On day 3 after oocyte retrieval (up to 25 days after start of stimulation)
Number of Blastocysts
Time Frame: On day 5 after oocyte retrieval (up to 27 days after start of stimulation)
The number of blastocysts (total and good-quality) was reported. Blastocyst quality is assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring is based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells)
On day 5 after oocyte retrieval (up to 27 days after start of stimulation)
Circulating Concentrations of Follicle-stimulating Hormone (FSH)
Time Frame: On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)
Blood samples for analysis of circulating concentrations of FSH were drawn.
On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)
Circulating Concentrations of Luteinizing Hormone (LH)
Time Frame: On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)
Blood samples for analysis of circulating concentrations of LH were drawn
On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)
Circulating Concentrations of Estradiol
Time Frame: On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)
Blood samples for analysis of circulating concentrations of estradiol were drawn
On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)
Circulating Concentrations of Progesterone
Time Frame: On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)
Blood samples for analysis of circulating concentrations of progesterone were drawn
On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)
Circulating Concentrations of Inhibin B
Time Frame: On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)
Blood samples for analysis of circulating concentrations of Inhibin B were drawn
On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation)
Total Gonadotropin Dose
Time Frame: Up to 20 days
Calculated by start dates, end dates and daily dose of investigational medicinal product
Up to 20 days
Number of Stimulation Days
Time Frame: Up to 20 days
Calculated by start dates and end dates
Up to 20 days
Positive Beta Human Chorionic Gonadotropin (βhCG) Rate
Time Frame: 13-15 days after transfer (up to approximately 1.5 months after start of stimulation)
Defined as positive serum βhCG test
13-15 days after transfer (up to approximately 1.5 months after start of stimulation)
Implantation Rate
Time Frame: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
Defined as the number of gestational sacs after transfer divided by number of blastocysts transferred
5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
Clinical Pregnancy Rate
Time Frame: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
Defined as at least one gestational sac
5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
Vital Pregnancy Rate
Time Frame: 5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
Defined as at least one intrauterine gestational sac with fetal heart beat
5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation)
Ongoing Pregnancy Rate
Time Frame: 10-11 weeks after transfer (up to approximately 4 months after start of stimulation)
At least one intrauterine viable fetus
10-11 weeks after transfer (up to approximately 4 months after start of stimulation)
Ongoing Implantation Rate
Time Frame: 10-11 weeks after transfer (up to approximately 4 months after start of stimulation)
Defined as number of intrauterine viable fetuses divided by the number of blastocysts transferred
10-11 weeks after transfer (up to approximately 4 months after start of stimulation)
Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade)
Time Frame: Up to 9 days after triggering of final follicular maturation
Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.
Up to 9 days after triggering of final follicular maturation
Proportion of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade)
Time Frame: >9 days after triggering of final follicular maturation
Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.
>9 days after triggering of final follicular maturation
Frequency of Adverse Events
Time Frame: From time of signing informed consent until the end-of-trial (approximately 7 months)
Any untoward medical occurrence
From time of signing informed consent until the end-of-trial (approximately 7 months)
Intensity of Adverse Events
Time Frame: From time of signing informed consent until the end-of-trial (approximately 7 months)
Categorized as mild, moderate or severe
From time of signing informed consent until the end-of-trial (approximately 7 months)
Technical Malfunctions of the Pre-filled Injection Pen
Time Frame: Up to 20 days
Incidences of technical malfunctions of the pre-filled injection pen were recorded
Up to 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 000304
  • 2017-002783-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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