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 Stimulation (TIFFANY)

Ferring

Status and phase: Withdrawn; Phase 2

Conditions: Infertility

Treatments: Drug: FE 999302; Drug: Ovitrelle; Drug: Novarel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05571111

000298

Details and patient eligibility

About

The primary purpose of this trial is to compare three different doses of FE 999302 with 250 µg OVITRELLE and 10,000 IU NOVAREL on oocyte maturity when administered as a single dose for final development of the oocytes in women undergoing controlled ovarian stimulation.

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• 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 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).
• No more than two controlled ovarian stimulation cycles initiated, regardless outcome (taking exclusion criteria 3, 4, and 5 into account).
• Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.

Exclusion criteria

• Known polycystic ovary syndrome (PCOS) associated with anovulation or known endometriosis stage III-IV (American Society for Reproductive Medicine, 2012).
• 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.
• 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.
• 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).
• Severe OHSS in a previous controlled ovarian stimulation cycle.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 5 patient groups

Dose 1 of FE 999302

Experimental group

Description:

Subcutaneous injection of Dose 1 of FE 999302 as a single dose.

Treatment:

Drug: FE 999302

Dose 2 of FE 999302

Experimental group

Description:

Subcutaneous injection of Dose 2 of FE 999302 as a single dose.

Treatment:

Drug: FE 999302

Dose 3 of FE 999302

Experimental group

Description:

Subcutaneous injection of Dose 3 of FE 999302 as a single dose.

Treatment:

Drug: FE 999302

250 μg OVITRELLE

Active Comparator group

Description:

Subcutaneous injection of 250 μg of OVITRELLE. 0.5 mL as a single dose.

Treatment:

Drug: Ovitrelle

10,000 IU NOVAREL

Active Comparator group

Description:

Subcutaneous injection of 10,000 IU NOVAREL. 1 mL as a single dose.

Treatment:

Drug: Novarel