Clinical Research Study to Learn About the Effect and Safety of Different Doses of FE 999302 When Given as a Single Dose for Final Development of the Eggs After Ovarian Stimulation
NCT ID: NCT05571111
Last Updated: 2023-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2022-10-04
2024-06-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dose 1 of FE 999302
Subcutaneous injection of Dose 1 of FE 999302 as a single dose.
FE 999302
Subcutaneous injection as a single dose. 3 different doses
Dose 2 of FE 999302
Subcutaneous injection of Dose 2 of FE 999302 as a single dose.
FE 999302
Subcutaneous injection as a single dose. 3 different doses
Dose 3 of FE 999302
Subcutaneous injection of Dose 3 of FE 999302 as a single dose.
FE 999302
Subcutaneous injection as a single dose. 3 different doses
250 μg OVITRELLE
Subcutaneous injection of 250 μg of OVITRELLE. 0.5 mL as a single dose.
Ovitrelle
Subcutaneous injection as a single dose. 250 µg (0.5 mL)
10,000 IU NOVAREL
Subcutaneous injection of 10,000 IU NOVAREL.
1 mL as a single dose.
Novarel
Subcutaneous injection as a single dose. 10,000 IU (1 mL)
Interventions
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FE 999302
Subcutaneous injection as a single dose. 3 different doses
Ovitrelle
Subcutaneous injection as a single dose. 250 µg (0.5 mL)
Novarel
Subcutaneous injection as a single dose. 10,000 IU (1 mL)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
* Infertility for at least 1 year before screening for subjects \<35 years or for at least 6 months for subjects ≥35 years (not applicable in case of tubal or severe male factor infertility).
Exclusion Criteria
* Known polycystic ovary syndrome (PCOS) associated with anovulation or known endometriosis stage III-IV (American Society for Reproductive Medicine, 2012).
* Considered unsuitable for controlled ovarian stimulation with a starting dose of 150 or 225 IU/day highly purified human menopausal gonadotropin (HP-hMG), as judged by the investigator.
* Poor response in a previous controlled ovarian stimulation cycle using a gonadotropin starting dose of 150 IU/day or higher. Poor response is defined as \<4 oocytes retrieved, or cycle cancellation prior to oocyte retrieval due to inadequate follicular development.
* Excessive ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI using a daily FSH/hMG dose of ≤225 IU, defined as ≥25 oocytes retrieved or cycle cancellation prior to oocyte retrieval due to excessive ovarian response, including risk of ovarian hyperstimulation syndrome (OHSS).
* Severe OHSS in a previous controlled ovarian stimulation cycle.
18 Years
42 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Ferring Investigational Site
Madrid, , Spain
Ferring Investigational Site
Seville, , Spain
Ferring Investigational Site
Valencia, , Spain
Countries
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Other Identifiers
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000298
Identifier Type: -
Identifier Source: org_study_id
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