An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation.

NCT06511791 | Terminated Phase 1

• 2 other identifiers: 0004272023-508149-42-00
• Study Type: interventional
• Target: 106
• Locations: 5 countries
• Sites: 15

Brief Summary

This is a phase 1b clinical trial with Choriogonadotropin beta (FE999302) and Follitropin delta (Rekovelle). The trial is a randomised, double blind, placebo controlled, parallel group, exploratory trial, investigating the effect of FE 999302 when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a antagonist protocol.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Number of good-quality blastocysts

  Number of good-quality blastocysts on day 5 after oocyte retrieval

  Day 5

Secondary Outcomes (13)

• Number and Size of Follicles

  Day 5 and up to 20 days

• Serum hormone concentrations

  Day 5, up to 20 days, and up to 22 days

• Number of Stimulation Days

  Up to 20 days

• Number of Oocytes

  Up to 22 days

• Number of metaphase II oocytes

  Up to 22 days

Study Arms (4)

Placebo Group

PLACEBO COMPARATOR

Placebo from day 1 to end of stimulation

Drug: Follitropin delta; Drug: Placebo FE 999302

FE 999302 Group

ACTIVE COMPARATOR

FE 999302 from stimulation day 1 to end-of-stimulation

Drug: FE 999302; Drug: Follitropin delta

FE 999302 and Placebo Group

ACTIVE COMPARATOR

FE 999302 from stimulation day 1 to stimulation day 5, and placebo stimulation day 6 to end-of-stimulation

Drug: FE 999302; Drug: Follitropin delta; Drug: Placebo FE 999302

Placebo and FE 999302

ACTIVE COMPARATOR

Placebo from stimulation day 1 to stimulation 5, FE 999302 from stimulation day 6 to end-of-stimulation.

Drug: FE 999302; Drug: Follitropin delta; Drug: Placebo FE 999302

Interventions

FE 999302 DRUG

Effect on parameters influencing pregnancy rates when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol

FE 999302 Group; FE 999302 and Placebo Group; Placebo and FE 999302

Follitropin delta DRUG

The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.

Also known as: REKOVELLE

FE 999302 Group; FE 999302 and Placebo Group; Placebo Group; Placebo and FE 999302

Placebo FE 999302 DRUG

No active ingredient, subcutaneous injection.

FE 999302 and Placebo Group; Placebo Group; Placebo and FE 999302

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject informed consent form signed before any trial-related activities.
• In good physical and mental health as judged by the investigator.
• Serum anti-Müllerian hormone (AMH) levels of \>35.0 pmol/L at screening (measured at central laboratory).
• Pre-menopausal women between the ages of 18 and 40 years. The subjects must be at least 18 years (including the 18th birthday) and no more than 40 years (up to the day before the 41st birthday) when they sign the informed consent(s).
• 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.
• Early follicular phase (cycle day 2-5) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (measured at central laboratory).
• Body mass index (BMI) between 18.0 and 32.0 kg/m2 (both inclusive) at screening.
• Known polycystic ovary syndrome (PCOS) or known endometriosis stage III-IV (American Society for Reproductive Medicine, 2012).
• Poor response in a previous controlled ovarian stimulation cycle using a gonadotropin starting dose of 150 IU/day (corresponding to 10 µg follitropin delta) or higher. Poor response is defined as \<4 oocytes retrieved, or cycle cancellation before oocyte retrieval due to inadequate follicular development.
• Severe ovarian hyperstimulation syndrome (OHSS; grade 4 or 5) in a previous controlled ovarian stimulation cycle, as judged by the investigator.
• One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound before randomisation on stimulation day 1 (puncture of cysts is allowed before randomisation).
• Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
• Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver, or kidney) with the exception of controlled thyroid function disease.
• Known tumours of the ovary, breast, uterus, adrenal gland, pituitary, or hypothalamus which would contraindicate the use of gonadotropins.
• 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.
• Currently breast-feeding.
• Undiagnosed vaginal bleeding.
• 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.
• Pregnancy (negative urinary pregnancy tests must be documented at screening and before randomisation) or contraindication to pregnancy.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (15)

Ferring Investigational Site

Brussels, 1090, Belgium

Location

Ferring Investigational Site

Edegem, 2650, Belgium

Location

Ferring Investigational Site

Prague, 150 00, Czechia

Location

Ferring Investigational Site

Prague, 16000, Czechia

Location

Ferring Investigational Site

Prague, 184 00, Czechia

Location

Ferring Investigational Site

Copenhagen, 2100, Denmark

Location

Ferring Investigational Site

Hvidovre, 2650, Denmark

Location

Ferring Investigational Site

Bergen, 5006, Norway

Location

Ferring Investigational Site

Porsgrunn, 3913, Norway

Location

Ferring Investigational Site

Trondheim, 7042, Norway

Location

Ferring Investigational Site

Barcelona, 08028, Spain

Location

Ferring Investigational Site

Madrid, 28010, Spain

Location

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

follitropin delta

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Ferring Pharmaceuticals

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 22, 2024
• Study Start: July 15, 2024
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3); DK (2); ES (5); NO (3); BE (2)