Women diagnosed with tubal infertility or unexplained infertility or endometriosis stage I/II or having partners diagnosed with male factor infertility, eligible for IVF and/or ICSI. MedDRA version: 20.1 Level: LLT Classification code 10021940 Term: Infertility, female, of unspecified origin System Organ Class: 100000004872 MedDRA version: 21.0 Level: LLT Classification code 10016403 Term: Female infertility of tubal origin System Organ Class: 100000004872 MedDRA version: 21.1 Level: LLT Cla
Conditions
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent documents signed prior to screening evaluations. 2. In good physical and mental health as judged by the investigator. 3. Anti-Müllerian hormone (AMH) levels at screening of 5.0-35.0 pmol/L (as measured by Elecsys® AMH Plus Immunoassay [Roche Diagnostics] at central laboratory). 4. Pre-menopausal women between the ages of 30 and 42 years. The subjects must be at least 30 years (including the 30th birthday) and no more than 42 years (up to the day before the 43rd birthday) when they sign the informed consent. 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known polycystic ovary syndrome (PCOS) associated with anovulation or known endometriosis stage III-IV (defined by the revised American Society for Reproductive Medicine [ASRM] classification, 1996). 4. One or more follicles =10 mm (including cysts) observed on the transvaginal ultrasound after down-regulation prior to randomisation on stimulation day 1 (puncture of cysts is allowed prior to randomisation). 20. Pregnancy (negative pregnancy tests must be documented at screening and prior to start of down-regulation) or contraindication to pregnancy. For further exclusion criteria refer to protocol v 2.0 dated 15Dec2017
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of FE 999302 on parameters influencing pregnancy rates in women undergoing COS with follitropin delta in a long GnRH agonist protocol;Secondary Objective: - To investigate the safety of FE 999302 in women undergoing COS with follitropin delta in a long GnRH agonist protocol - To investigate the potential immunogenicity of FE 999302 in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol - To estimate the impact of body weight on FE 999302 exposure in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol;Primary end point(s): Number of good-quality blastocysts on day 5 after oocyte retrieval (grade 3BB or higher);Timepoint(s) of evaluation of this end point: day 5 after oocyte retrieval | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number and quality of embryos on day 3 after oocyte retrieval - Number and quality of blastocysts on day 5 after oocyte retrieval - Changes in serum hormone levels from stimulation day 1 to stimulation day 6, stimulation day 8, end-of-stimulation (progesterone, 17-OH-progesterone, androstenedione, testosterone, estradiol, inhibin A, inhibin B, FSH, and LH), and oocyte retrieval (progesterone, 17-OH-progesterone, androstenedione, testosterone, estradiol) - Positive ßhCG (positive serum ßhCG test 13-15 days after transfer) -Clinical pregnancy (at least one gestational sac 5-6 weeks after transfer) - Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer) - Ongoing pregnancy (at least one intrauterine viable fetus 10-11 weeks after transfer) - Number of oocytes retrieved - Number of metaphase II oocytes - Number of fertilised (2PN) oocytes - Incidence of ovarian hyperstimulation syndrome (early or late, any grade) - Incidence and intensity of adverse events;Timepoint(s) of evaluation of this end point: Timepoint is included in the relevant endpoint | — |
Countries
Belgium, Czech Republic, Denmark, Spain, United Kingdom
Contacts
Public ContactGlobal Clinical R&D
Ferring Pharmaceuticals A/S
Outcome results
None listed