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

NCT05571111 | Withdrawn Phase 2 DMC

• 1 other identifier: 000298
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Number of metaphase II (MII) oocytes

  On the day of oocyte retrieval (2 days after triggering)

Secondary Outcomes (22)

• Number of oocytes retrieved

  On the day of oocyte retrieval (2 days after triggering)

• Number of fertilised (2 pronuclei) oocytes

  On day 1 insemination (3 days after triggering)

• Number and quality of embryos on day 3 after oocyte retrieval

  Day 3 after insemination (5 days after triggering)

• Number and quality of blastocysts on day 5 after oocyte retrieval

  Day 5 after insemination (7 days after triggering)

• Serum hormone concentrations of progesterone

  Blood samples for analysis of circulating concentrations of progesterone will be drawn at several visits from day of triggering up to 22 days after triggering

Study Arms (5)

Dose 1 of FE 999302

EXPERIMENTAL

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

Drug: FE 999302

Dose 2 of FE 999302

EXPERIMENTAL

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

Drug: FE 999302

Dose 3 of FE 999302

EXPERIMENTAL

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

Drug: FE 999302

250 μg OVITRELLE

ACTIVE COMPARATOR

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

Drug: Ovitrelle

10,000 IU NOVAREL

ACTIVE COMPARATOR

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

Drug: Novarel

Interventions

FE 999302 DRUG

Subcutaneous injection as a single dose. 3 different doses

Also known as: recombinant hCG

Dose 1 of FE 999302; Dose 2 of FE 999302; Dose 3 of FE 999302

Ovitrelle DRUG

Subcutaneous injection as a single dose. 250 µg (0.5 mL)

250 μg OVITRELLE

Novarel DRUG

Subcutaneous injection as a single dose. 10,000 IU (1 mL)

10,000 IU NOVAREL

Eligibility Criteria

• Age: 18 Years - 42 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (3)

Ferring Investigational Site

Madrid, 28023, Spain

Location

Ferring Investigational Site

Seville, 41092, Spain

Location

Ferring Investigational Site

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 7, 2022
• Study Start: October 4, 2022
• Primary Completion: March 25, 2024
• Study Completion: June 25, 2024
• Last Updated: January 9, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)