A trial to compare the ovarian response of REKOVELLE and GONAL-F in conventional dosing in women undergoing controlled ovarian stimulatio
- Conditions
- Infertility in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycleMedDRA version: 20.0Level: PTClassification code 10021928Term: Infertility femaleSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2021-001785-38-AT
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 300
1. Informed Consent Form signed prior to screening evaluations.
2. In good physical and mental health.
3. 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.
4. 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.
5. 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).
6. Regular menstrual cycles of 21-35 days (both inclusive), presumed to be ovulatory.
7. 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.
8. 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Primary ovarian failure.
2. Known endometriosis stage III-IV.
3. Considered unsuitable for controlled ovarian stimulation with a dosing regimen corresponding to approximately 225 IU/day gonadotropin, as judged by the investigator.
4. History of previous episode of OHSS or exuberant ovarian response to gonadotropins, and polycystic ovarian syndrome.
5. 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).
6. 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.
7. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
8. Fibroid tumours of the uterus incompatible with pregnancy.
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 prior to randomisation) or contraindication to pregnancy.
13. Use of fertility modifiers during the last menstrual cycle before randomisation, including dehydroepiandrosterone (DHEA) or cycle programming with oral contraceptives, progestogen or estrogen preparations.
14. Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial.
15. Previous participation in the trial.
16. Use of any non-registered investigational drugs during the last 3 months prior to randomisation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare a starting dose of 15 µg REKOVELLE to a starting dose of 225 IU GONAL F in conventional regimens with respect to ovarian response in women undergoing controlled ovarian stimulation;Secondary Objective: • To compare the follicular development, endocrine profile and embryo development associated with conventional dosing of REKOVELLE and GONAL-F<br>• To compare the treatment efficiency associated with conventional dosing of REKOVELLE and GONAL-F<br>• To compare the safety profile associated with conventional dosing of REKOVELLE and GONAL-F<br>;Primary end point(s): Number of oocytes retrieved ;Timepoint(s) of evaluation of this end point: Oocyte retrieval will take place 36h (±2h) after triggering of final follicular maturation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Number of follicles (total and by size category) at end-of-stimulation<br>• Serum concentrations of estradiol and progesterone at end-of-stimulation<br>• Number of fertilised oocytes and fertilisation rate<br>• Number of blastocysts (total and by quality) <br>• Total gonadotropin dose and number of stimulation days<br>• Early OHSS (overall and by grade) and/or preventive interventions for early OHSS<br>;Timepoint(s) of evaluation of this end point: Timepoint is included in the relevant endpoint