Condition or disease | Intervention/treatment | Phase |
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Infertility, Female | Drug: FE 999049 + GnRH agonist (GONAPEPTYL) Drug: FE 999049 + GnRH antagonist (CETROTIDE) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 415 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | April 29, 2019 |
Estimated Primary Completion Date : | December 15, 2021 |
Estimated Study Completion Date : | September 30, 2022 |
Arm | Intervention/treatment |
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Experimental: FE 999049 + GnRH agonist (GONAPEPTYL) |
Drug: FE 999049 + GnRH agonist (GONAPEPTYL)
FE 999049 + GnRH agonist (GONAPEPTYL)
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Experimental: FE 999049 + GnRH antagonist (CETROTIDE) |
Drug: FE 999049 + GnRH antagonist (CETROTIDE)
FE 999049 + GnRH antagonist (CETROTIDE)
|
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Women undergoing their first IVF/ICSI cycle and aged 18-40 years will be included. |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Global Clinical Compliance | +1 833-548-1402 (US/Canada) | DK0-Disclosure@ferring.com | |
Contact: Global Clinical Compliance | +1 862-286-5200 (outside US) | DK0-Disclosure@ferring.com |
Study Director: | Global Clinical Compliance | Ferring Pharmaceuticals |
Tracking Information | |||||||||
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First Submitted Date ICMJE | January 7, 2019 | ||||||||
First Posted Date ICMJE | January 18, 2019 | ||||||||
Last Update Posted Date | June 1, 2021 | ||||||||
Actual Study Start Date ICMJE | April 29, 2019 | ||||||||
Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Number of oocytes retrieved [ Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation) ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND) | ||||||||
Official Title ICMJE | 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 | ||||||||
Brief Summary | 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. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Infertility, Female | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
415 | ||||||||
Original Estimated Enrollment ICMJE |
400 | ||||||||
Estimated Study Completion Date ICMJE | September 30, 2022 | ||||||||
Estimated Primary Completion Date | December 15, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 40 Years (Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Austria, Denmark, Israel, Italy, Netherlands, Norway, Switzerland | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03809429 | ||||||||
Other Study ID Numbers ICMJE | 000304 2017-002783-40 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Ferring Pharmaceuticals | ||||||||
Study Sponsor ICMJE | Ferring Pharmaceuticals | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Ferring Pharmaceuticals | ||||||||
Verification Date | April 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |