An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation
NCT ID: NCT06466486
Last Updated: 2025-10-02
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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TERMINATED
PHASE1
310 participants
INTERVENTIONAL
2024-06-14
2025-09-05
Brief Summary
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The trial is multicentre, randomized, partially double-blind, placebo-controlled, parallel-group investigating the effect of FE999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Placebo
Follitropin delta and FE 999302 placebo
Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
FE999302 Placebo
To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
FE999302 and Placebo Every 2nd Day Group
Follitropin delta and FE 999302 every 2nd day and FE 999302 placebo every 2nd day
Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
FE999302
To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
FE999302 Placebo
To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
FE999302 Dose Group 1
Follitropin delta and FE 999302
Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
FE999302
To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
FE999302 Dose Group 2
Follitropin delta and FE 999302
Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
FE999302
To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
Placebo Group 2
Follitropin delta and FE 999302 placebo
Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
FE999302 Placebo
To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
FE999302 Dose Group 3
Follitropin delta and FE 999302
Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
FE999302
To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
Interventions
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Follitropin delta
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
FE999302
To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
FE999302 Placebo
To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
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 15.0-35.0 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 30.0 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 or higher. Poor response is defined as \<4 oocytes retrieved, or cycle cancellation before oocyte retrieval due to inadequate follicular development.
3. Excessive ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI using a daily FSH/ human menopausal gonadotropin (hMG) dose of ≤225 IU, defined as ≥25 oocytes retrieved or cycle cancellation before oocyte retrieval due to excessive ovarian response, including risk of ovarian hyperstimulation syndrome (OHSS).
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. Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy \[excluding ectopic pregnancy\] and before week 24 of pregnancy).
6. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
7. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver, or kidney) with the exception of controlled thyroid function disease.
8. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary, or hypothalamus which would contraindicate the use of gonadotropins.
9. 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.
10. Currently breast-feeding.
11. Undiagnosed vaginal bleeding.
12. 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.
13. Pregnancy (negative urinary pregnancy tests must be documented at screening and before randomisation) or contraindication to pregnancy.
14. Use of fertility modifiers during the last menstrual cycle before start of stimulation in the trial, including dehydroepiandrosterone (DHEA) and metformin or cycle programming with oral contraceptives, progestogen, or estrogen preparations
18 Years
40 Years
FEMALE
Yes
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
Brussels, , Belgium
Ferring Investigational Site
Edegem, , Belgium
Ferring Investigational Site
Prague, Prague, Czechia
Ferring Investigational Site
Prague, , Czechia
Ferring Investigational Site
Prague, , Czechia
Ferring Investigational Site
Hvidovre, Hvidovre, Denmark
Ferring Investigational Site
Copenhagen, , Denmark
Ferring Investigational Site
Trondheim, Sor-Trondelag, Norway
Ferring Investigational Site
Bergen, , Norway
Ferring Investigational Site
Porsgrunn, , Norway
Ferring Investigational Site
Madrid, Aravaca, Spain
Ferring Investigational Site
Barcelona, , 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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2023-507630-25-00
Identifier Type: CTIS
Identifier Source: secondary_id
000426
Identifier Type: -
Identifier Source: org_study_id
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