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Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03228680
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation

Condition or disease Intervention/treatment Phase
Infertility Drug: Follitropin delta Drug: Follitropin beta Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme
Actual Study Start Date : July 29, 2017
Actual Primary Completion Date : June 10, 2019
Actual Study Completion Date : July 8, 2019

Arm Intervention/treatment
Experimental: Follitropin delta Drug: Follitropin delta
Subcutaneous administration through pre-filled injection
Other Names:
  • FE 999049
  • Rekovelle

Active Comparator: Follitropin beta Drug: Follitropin beta
Single daily subcutaneous injection in the abdomen.
Other Name: Follistim




Primary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: 36h (± 2h) after triggering of final follicular maturation ]

Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 5-6 weeks after transfer ]
    Pregnancy defined as at least one gestational sac

  2. Positive βhCG rate [ Time Frame: 13-15 days after transfer ]
    Measured by positive serum βhCG test

  3. Vital pregnancy [ Time Frame: 5-6 weeks after transfer ]
    Rated as at least one intrauterine gestational sac with fetal heart beat

  4. Implantation rate [ Time Frame: 5-6 weeks after transfer ]
    Number of gestational sacs divided by number of blastocysts transferred

  5. Proportion of subjects with cycle cancellation due to poor or excessive ovarian response or blastocyst transfer cancellation due to excessive ovarian response / OHSS risk [ Time Frame: End of stimulations visit or transfer visit =up to 4 weeks ]
    For each subject, the reason for each cycle cancellation will be recorded

  6. Proportion of subjects with <4, 4-7, 8-14, 15-19 and ≥20 oocytes retrieved [ Time Frame: On the day of oocyte retrieval ]
    Grouped according to number of oocytes

  7. Proportion of subjects with extreme ovarian responses [ Time Frame: On the day of oocyte retrieval ]
    Defined as <4, ≥15 or ≥20 oocytes retrieved

  8. Proportion of subjects with preventive interventions for early ovarian hyperstimulation syndrome (OHSS) [ Time Frame: Up to 20 stimulation days ]
    Measured as cycle cancellation due to excessive ovarian response or GnRH agonist triggering

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

  10. Proportions 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

  11. Number of follicles [ Time Frame: Up to 20 stimulation days ]
    Counted for the right and left ovary via ultrasound

  12. Size of follicles [ Time Frame: Up to 20 stimulation days ]
    Measured for the right and left ovary via ultrasound

  13. Fertilisation rate [ Time Frame: Day 1 after oocyte retrieval ]
    Measured by number of pronuclei

  14. Number and quality of embryos [ Time Frame: Day 3 after oocyte retrieval ]
    Combined assesment of number of blastomeres/compaction status and embryo morphology parameters

  15. Number and quality of blastocysts [ Time Frame: Day 5 after oocyte retrieval ]
    Assessed as a score combining three parameters (blastocyst expansion and hatching status, inner cell mass and trophectoderm)

  16. Circulating levels of endocrine parameters [ Time Frame: At stimulation day 6 and end-of-stimulation (up to 20 stimulation days) ]
    Measured by follicle-stimulating hormone (FSH), luteinising hormone (LH), estradiol, progesterone, inhibin A and inhibin B

  17. Total gonadotropin dose [ Time Frame: Up to 20 stimulation days ]
    Calculated by start dates, end dates and daily dose of investigational medicinal product (IMP)

  18. Number of stimulation days [ Time Frame: Up to 20 stimulation days ]
    Calculated by start dates, end dates and daily dose of IMP

  19. Frequency of adverse events [ Time Frame: From signed informed consent up to 5-6 weeks after transfer ]
    Recorded for FE 999049 and FOLLISTIM

  20. Intensity of adverse events [ Time Frame: From signed informed consent up to 5-6 weeks after transfer ]
    Recorded for FE 999049 and FOLLISTIM

  21. Changes in circulating levels of clinical chemistry compared to baseline [ Time Frame: End-of-stimulation and up to 5-6 weeks after transfer ]
    Measured by CHEM-20

  22. Changes in haematology parameters compared to baseline [ Time Frame: End-of-stimulation and up to 5-6 weeks after transfer ]
    Measured by complete blood count

  23. Frequency of injection site reactions [ Time Frame: Up to 20 stimulation days ]
    Assessed by subjects during the stimulation period

  24. Intensity of injection site reactions [ Time Frame: Up to 20 stimulation days ]
    Assessed by subjects during the stimulation period

  25. Technical malfunctions [ Time Frame: Up to 20 stimulation days ]
    Of the administration pens



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent Documents signed prior to any trial-related procedures.
  • In good physical and mental health.
  • Japanese females between the ages of 20 and 40 years.
  • Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II (defined by the revised American Society for Reproductive Medicine (ASRM) classification) or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) treatment using ejaculated sperm from male partner.
  • Infertility for at least 1 year before randomisation (not applicable in case of tubal or severe male factor infertility).
  • The trial cycle will be the subject's first controlled ovarian stimulation cycle for IVF/ICSI.
  • Hysterosalpingography, hysteroscopy, saline infusion sonography or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to screening. This also includes women who have been diagnosed with any of the above medical conditions but have had them surgically corrected within 1 year prior to screening.
  • Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm or enlarged ovaries which would contraindicate the use of gonadotropins) and fallopian tubes and surrounding tissue without evidence of significant abnormality (e.g. no hydrosalpinx) within 1 year prior to screening. Both ovaries must be accessible for oocyte retrieval.
  • Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to screening).
  • Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.

Exclusion Criteria:

  • Known endometriosis stage III-IV (defined by the revised ASRM classification).
  • One or more follicles >10 mm (including cysts) observed on the transvaginal ultrasound prior to start of stimulation on stimulation day 1 (puncture of cysts prior randomisation is allowed).
  • Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy).
  • Known abnormal karyotype of subject or of her partner. In case the sperm production is severely impaired (concentration <1 million/mL), normal karyotype, including no Y chromosome microdeletion, must be documented.
  • Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
  • Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
  • Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease.
  • Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.

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): NCT03228680


Locations
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Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Global Clinical Compliance Ferring Pharmaceuticals
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03228680    
Other Study ID Numbers: 000273
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs