Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03809429
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: FE 999049 + GnRH agonist (GONAPEPTYL) Drug: FE 999049 + GnRH antagonist (CETROTIDE) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 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 : November 13, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FE 999049 + GnRH agonist (GONAPEPTYL) Drug: FE 999049 + GnRH agonist (GONAPEPTYL)
FE 999049 + GnRH agonist (GONAPEPTYL)

Experimental: FE 999049 + GnRH antagonist (CETROTIDE) Drug: FE 999049 + GnRH antagonist (CETROTIDE)
FE 999049 + GnRH antagonist (CETROTIDE)




Primary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation) ]

Secondary Outcome Measures :
  1. 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 subject, the reason for cycle cancellation will be recorded

  2. 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 subject, the reason for blastocyst transfer cancellation will be recorded

  3. 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

  4. 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

  5. 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

  6. 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 will be regarded as correctly fertilized

  7. 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) will be reported. Embryo quality is determined by combined assesment of cleavage stage (number of blastomeres/compaction status) and embryo morphology parameters

  8. 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) will be 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)

  9. Circulating concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone and 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) ]
  10. Total gonadotropin dose [ Time Frame: Up to 20 days ]
    Calculated by start dates, end dates and daily dose of investigational medicinal product

  11. Number of stimulation days [ Time Frame: Up to 20 days ]
    Calculated by start dates and end dates

  12. 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. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. Proportion of subjects with early OHSS (including OHSS of moderate/severe grade) [ Time Frame: Up to 9 days after triggering of final follicular maturation ]
    Measured as mild, moderate or severe

  19. Proportion of subjects with late OHSS (including OHSS of moderate/severe grade) [ Time Frame: >9 days after triggering of final follicular maturation ]
    Measured as mild, moderate or severe

  20. Frequency of adverse events [ Time Frame: From time of signing informed consent until the end-of-trial (approximately 7 months) ]
    Any untoward medical occurrence

  21. 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

  22. Technical malfunctions of the pre-filled injection pen [ Time Frame: Up to 20 days ]
    Incidences of technical malfunctions of the pre-filled injection pen will be recorded



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809429


Contacts
Layout table for location contacts
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

Locations
Layout table for location information
Austria
Das Kinderwunsch Institut Schenk GmbH Not yet recruiting
Dobl, Austria
Kepler University Hospital Linz Not yet recruiting
Linz, Austria
AKH Wien Not yet recruiting
Vienna, Austria
Kinderwunschzentrum Goldenes Kreuz Privatklinik Not yet recruiting
Vienna, Austria
Denmark
Rigshospitalet Not yet recruiting
Copenhagen, Denmark
Israel
Hillel Yafe Medical Center Not yet recruiting
Hadera, Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Beilinson Hospital Rabin Medical Center Not yet recruiting
Petah tikva, Israel
Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Italy
Dipartimento della Donna, del bambino e delle malattie urologiche Not yet recruiting
Bologna, Italy
European Hospital Not yet recruiting
Roma, Italy
Humanitas Research Hospital Not yet recruiting
Rozzano, Italy
Netherlands
St. Elisabeth Ziekenhuis Not yet recruiting
Tilburg, Netherlands
Isala Fertility Center Not yet recruiting
Zwolle, Netherlands
Norway
Oslo University Hospital Not yet recruiting
Oslo, Norway
Sykehuset Telemark HF Not yet recruiting
Porsgrunn, Norway
Medicus AS Recruiting
Trondheim, Norway
Switzerland
Gyn-A.R.T. AG Not yet recruiting
Zürich, Switzerland
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Global Clinical Compliance Ferring Pharmaceuticals

Layout table for additonal information
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03809429     History of Changes
Other Study ID Numbers: 000304
2017-002783-40 ( EudraCT Number )
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Prolactin Release-Inhibiting Factors
Follicle Stimulating Hormone
Deslorelin
Triptorelin Pamoate
Cetrorelix
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Hormone Antagonists