Clinical research study to learn about the effect and safety of different doses of FE 999302 when given as a single dose for final development of the eggs after ovarian stimulatio

Phase 1

• Conditions: Infertility; MedDRA version: 20.1Level: LLTClassification code 10016398Term: Female infertilitySystem Organ Class: 100000004872; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2022-000753-80-DK
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-04
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

1. Subject informed consent form signed prior to any trial-related activities.
2. Parental informed consent form signed prior to start of stimulation in the trial.
3. In good physical and mental health as judged by the investigator.
4. Pre-menopausal women between the ages of 18 and 42 years. The subjects must be at least 18 years (including the 18th 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 <35 years or for at least 6 months for subjects =35 years (not applicable in case of tubal or severe male factor infertility).
7 No more than two controlled ovarian stimulation cycles initiated, regardless outcome (taking exclusion criteria 3, 4, and 5 into account).
8. Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
9. Hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps, and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to start of stimulation in the trial.
10. Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to start of stimulation in the trial. Both ovaries must be accessible for oocyte retrieval.
11. Early follicular phase (cycle day 2-4) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (results obtained within 3 months prior to start of stimulation in the trial).
12. Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within 1 year prior to start of stimulation in the trial.
13. Follicular development with =3 follicles with a diameter =17 mm and <20 follicles with a diameter =12 mm observed on transvaginal ultrasound at the end of stimulation in the trial cycle.
14. Willing to accept ICSI regardless the cause of infertility.
15. Willing to accept transfer of a single good-quality blastocyst (double blastocyst transfer is allowed if no good-quality blastocyst is available).
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 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Known polycystic ovary syndrome (PCOS) associated with anovulation or known endometriosis stage III-IV
2. Considered unsuitable for controlled ovarian stimulation with a starting dose of 150 or 225 IU/day highly purified human menopausal gonadotropin (HP-hMG), as judged by the investigator.
3. 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 prior to oocyte retrieval due to inadequate follicular development.
4. Excessive ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI using a daily FSH/hMG dose of <225 IU, defined as =25 oocytes retrieved or cycle cancellation prior to oocyte retrieval due to excessive ovarian response, including risk of ovarian hyperstimulation syndrome (OHSS).
5. Severe OHSS in a previous controlled ovarian stimulation cycle.
6. One or more follicles =10 mm (including cysts) observed on the transvaginal ultrasound prior to start of ovarian stimulation on stimulation day 1 (puncture of cysts is allowed prior to start of stimulation).
7. Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy and before week 24 of pregnancy, excluding ectopic pregnancy).
8. Known abnormal karyotype of subject or of her partner/sperm donor, as applicable, depending on source of sperm used for insemination in this trial. In case partner sperm will be used and the sperm production is severely impaired (concentration <1 million/mL), normal karyotype, including no Y-chromosome microdeletion, must be documented.
9. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
10. Known inherited or acquired thrombophilia disease.
11. Known active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
12. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver, or kidney) with the exception of controlled thyroid function disease.
13. Known presence of anti-hCG antibodies (based on the information available in the subject’s medical records; i.e. not based on the anti-hCG antibody analyses conducted in the trial).
14. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary, or hypothalamus which would contraindicate the use of gonadotropins.
15. Known impairment of renal or hepatic function.
16. 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.
17. Currently breast-feeding.
18. Undiagnosed vaginal bleeding.
19. Known abnormal cervical cytology of clinical significance observed within 3 years prior to start of stimulation in the trial (unless the clinical significance has been resolved).
20. 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.
21. Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to start of stimulation) or contraindication to pregnancy.
22. Known current active pelvic inflammatory disease.
23. Use of fertility modifiers during the last menstrual cycle before start of stimulation in the trial, including dehydroepiandrosterone (DHEA) or cycle progra

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified