An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation.
NCT ID: NCT06511791
Last Updated: 2025-10-02
Study Results
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Basic Information
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TERMINATED
PHASE1
106 participants
INTERVENTIONAL
2024-07-15
2025-09-05
Brief Summary
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Detailed Description
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The primary endpoint is the number of good-quality blastocysts on day 5 after oocyte retrieval. Secondary endpoints are number of follicles by size category and serum concentration of different hormones on stimulation day 6 and end-of stimulation, the number of stimulation days and oocytes retrieved, the number of metaphase II oocytes and fertilised oocytes, number of blastocysts on day 5, number of cryopreserved blastocysts, endometrial thickness at eos, positive bhcg rate, clinical pregnancy, vital pregnancy and ongoing pregnancy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo Group
Placebo from day 1 to end of stimulation
Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
Placebo FE 999302
No active ingredient, subcutaneous injection.
FE 999302 Group
FE 999302 from stimulation day 1 to end-of-stimulation
FE 999302
Effect on parameters influencing pregnancy rates when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
FE 999302 and Placebo Group
FE 999302 from stimulation day 1 to stimulation day 5, and placebo stimulation day 6 to end-of-stimulation
FE 999302
Effect on parameters influencing pregnancy rates when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
Placebo FE 999302
No active ingredient, subcutaneous injection.
Placebo and FE 999302
Placebo from stimulation day 1 to stimulation 5, FE 999302 from stimulation day 6 to end-of-stimulation.
FE 999302
Effect on parameters influencing pregnancy rates when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
Placebo FE 999302
No active ingredient, subcutaneous injection.
Interventions
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FE 999302
Effect on parameters influencing pregnancy rates when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
Placebo FE 999302
No active ingredient, subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. In good physical and mental health as judged by the investigator.
3. Serum anti-Müllerian hormone (AMH) levels of \>35.0 pmol/L at screening (measured at central laboratory).
4. Pre-menopausal women between the ages of 18 and 40 years. The subjects must be at least 18 years (including the 18th birthday) and no more than 40 years (up to the day before the 41st birthday) when they sign the informed consent(s).
5. 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.
6. 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
9. Early follicular phase (cycle day 2-5) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (measured at central laboratory).
10. Body mass index (BMI) between 18.0 and 32.0 kg/m2 (both inclusive) at screening.
1. Known polycystic ovary syndrome (PCOS) or known endometriosis stage III-IV (American Society for Reproductive Medicine, 2012).
2. Poor response in a previous controlled ovarian stimulation cycle using a gonadotropin starting dose of 150 IU/day (corresponding to 10 µg follitropin delta) or higher. Poor response is defined as \<4 oocytes retrieved, or cycle cancellation before oocyte retrieval due to inadequate follicular development.
3. Severe ovarian hyperstimulation syndrome (OHSS; grade 4 or 5) in a previous controlled ovarian stimulation cycle, as judged by the investigator.
4. One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound before randomisation on stimulation day 1 (puncture of cysts is allowed before randomisation).
5. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
6. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver, or kidney) with the exception of controlled thyroid function disease.
7. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary, or hypothalamus which would contraindicate the use of gonadotropins.
8. Any abnormal finding of clinical chemistry and haematology at screening or vital signs at randomisation, which is judged clinically relevant by the investigator and/or requires intervention.
9. Currently breast-feeding.
10. Undiagnosed vaginal bleeding.
11. Findings at the gynaecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device.
12. Pregnancy (negative urinary pregnancy tests must be documented at screening and before randomisation) or contraindication to pregnancy.
13. Use of fertility modifiers during the last menstrual cycle before screening, including dehydroepiandrosterone (DHEA) and metformin or cycle programming with oral contraceptives, progestogen, or estrogen preparations.
18 Years
40 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Ferring Pharmaceuticals
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Ferring Investigational Site
Brussels, , Belgium
Ferring Investigational Site
Edegem, , Belgium
Ferring Investigational Site
Prague, , Czechia
Ferring Investigational Site
Prague, , Czechia
Ferring Investigational Site
Prague, , Czechia
Ferring Investigational Site
Copenhagen, , Denmark
Ferring Investigational Site
Hvidovre, , Denmark
Ferring Investigational Site
Bergen, , Norway
Ferring Investigational Site
Porsgrunn, , Norway
Ferring Investigational Site
Trondheim, , Norway
Ferring Investigational Site
Barcelona, , Spain
Ferring Investigational Site
Madrid, , Spain
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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2023-508149-42-00
Identifier Type: CTIS
Identifier Source: secondary_id
000427
Identifier Type: -
Identifier Source: org_study_id
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