A trial to investigate the efficacy and safety of FE 999302 as add-on treatment to follitropin delta (REKOVELLE) in women undergoing controlled ovarian stimulatio

Phase 1

• Conditions: Women diagnosed with tubal infertility or unexplained infertility orendometriosis stage I/II or having partners diagnosed with male factor infertility, eligible for IVF and/or ICSI.; MedDRA version: 21.0Level: LLTClassification code 10014784Term: Endometriosis of ovarySystem Organ Class: 100000004872; MedDRA version: 20.1Level: LLTClassification code 10021940Term: Infertility, female, of unspecified originSystem Organ Class: 100000004872; MedDRA version: 21.0Level: LLTClassification code 10016403Term: Female infertility of tubal originSystem Organ Class: 100000004872; MedDRA version: 21.1Level: LLTClassification code 10025511Term: Male infertility, unspecifiedSystem Organ Class: 100000004872; MedDRA version: 21.0Level: LLTClassification code 10014787Term: Endometriosis of uterusSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-003810-13-CZ
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-12
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 620

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 <35 years or for at least
6 months for subjects =35 years (not applicable in case of tubal or severe male factor
infertility).

For further inclusion criteria refer to protocol v 2.0 dated 15Dec2017
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 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

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