MENOPUR and REKOVELLE in Women UnderGoing an assisted reproductive technology cycle
- Conditions
- Infertility in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycleTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2022-500308-23-00
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 151
Informed Consent Form signed prior to screening evaluations., In good physical and mental health as judged by the investigator, and willing and able to comply with the trial protocol., Pre-menopausal females between the ages of 18 and 40 years. The subjects must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomisation., 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 one year before randomisation for subjects =37 years or for at least 6 months for subjects =38 years (not applicable in case of tubal or severe male factor infertility)., Regular menstrual cycles of 21-35 days (both inclusive), presumed to be ovulatory., Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm, and no enlarged ovaries or ovarian cyst not due to polycystic ovarian syndrome, which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomisation. 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 randomisation).
Primary ovarian failure., Currently breast-feeding., Undiagnosed vaginal bleeding., 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., Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to randomisation) or contraindication to pregnancy.e exception of controlled thyroid function disease., Use of fertility modifiers during the last menstrual cycle before randomisation, including dehydroepiandrosterone (DHEA) or cycle programming with oral contraceptives, progestogen or estrogen preparations.ns., Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial., Previous participation in the trial., Use of any non-registered investigational drugs during the last 3 months prior to randomisation., Known endometriosis stage III-IV., Considered unsuitable for controlled ovarian stimulation with a dosing regimen corresponding to approximately 225 IU/day gonadotropin, as judged by the investigator., History of previous episode of OHSS or exuberant ovarian response to gonadotropins, and polycystic ovarian syndrome.egnancy., One or more follicles =10 mm (including cysts) observed on the transvaginal ultrasound prior to randomisation on stimulation day 1 (puncture of cysts is allowed prior to randomisation)., 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., Fibroid tumours of the uterus incompatible with pregnancy., Active arterial or venous thromboembolism.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the ovarian response after controlled ovarian stimulation with different mixed protocols of REKOVELLE and MENOPUR;Secondary Objective: To evaluate the follicular development and endocrine profile associated with different mixed protocols of REKOVELLE and MENOPUR, To describe the embryo development associated with different mixed protocols of REKOVELLE and MENOPUR To describe the treatment efficiency associated with different mixed protocols of REKOVELLE and MENOPUR To describe the safety profile associated with different mixed protocols of REKOVELLE and MENOPUR, To describe the treatment efficiency associated with different mixed protocols of REKOVELLE and MENOPUR, To describe the safety profile associated with different mixed protocols of REKOVELLE and MENOPUR;Primary end point(s): Number of fertilised (2 pronuclei [2PN]) oocytes at 19±2 hours after insemination
- Secondary Outcome Measures
Name Time Method