An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation. (Celestial-2)

A Randomised, Double-blind, Placebo-controlled, Parallel-group Exploratory Trial to Investigate 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 Gonadotropin-releasing Hormone Antagonist Protocol.

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.

Study Overview

• Status: Terminated
• Conditions: Infertility
• Intervention / Treatment: Drug: Follitropin delta; Drug: Placebo FE 999302; Drug: FE 999302

Detailed Description

The trial is multicentre, randomized, partially double-blind, placebo-controlled, parallel-group investigating the effect of FE999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.

The primary endpoint is the number of good-quality blastocysts on day 5 after oocyte retrieval. Secondary endpoints are number of follicles by size category and serum concentration of different hormones on stimulation day 6 and end-of stimulation, the number of stimulation days and oocytes retrieved, the number of metaphase II oocytes and fertilised oocytes, number of blastocysts on day 5, number of cryopreserved blastocysts, endometrial thickness at eos, positive bhcg rate, clinical pregnancy, vital pregnancy and ongoing pregnancy.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Ferring Investigational Site
  • Edegem, Belgium, 2650
    • Ferring Investigational Site
• Czechia
  • Prague, Czechia, 150 00
    • Ferring Investigational Site
  • Prague, Czechia, 16000
    • Ferring Investigational Site
  • Prague, Czechia, 184 00
    • Ferring Investigational Site
• Denmark
  • Copenhagen, Denmark, 2100
    • Ferring Investigational Site
  • Hvidovre, Denmark, 2650
    • Ferring Investigational Site
• Norway
  • Bergen, Norway, 5006
    • Ferring Investigational Site
  • Porsgrunn, Norway, 3913
    • Ferring Investigational Site
  • Trondheim, Norway, 7042
    • Ferring Investigational Site
• Spain
  • Barcelona, Spain, 08028
    • Ferring Investigational Site
  • Madrid, Spain, 28023
    • Ferring Investigational Site
  • Madrid, Spain, 28010
    • Ferring Investigational Site
  • Seville, Spain, 41092
    • Ferring Investigational Site
  • Valencia, Spain, 46015
    • Ferring Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject informed consent form signed before any trial-related activities.
2. In good physical and mental health as judged by the investigator.
3. Serum anti-Müllerian hormone (AMH) levels of >35.0 pmol/L at screening (measured at central laboratory).
4. 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).
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 of outcome (taking exclusion criteria 2 and 3 into account) and the subject must be suitable for treatment with 10 or 15 µg/day follitropin delta (corresponding to 150 or 225 IU).
8. Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
9. Early follicular phase (cycle day 2-5) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (measured at central laboratory).
10. Body mass index (BMI) between 18.0 and 32.0 kg/m2 (both inclusive) at screening.

Exclusion Criteria:

1. Known polycystic ovary syndrome (PCOS) or known endometriosis stage III-IV (American Society for Reproductive Medicine, 2012).
2. 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.
3. Severe ovarian hyperstimulation syndrome (OHSS; grade 4 or 5) in a previous controlled ovarian stimulation cycle, as judged by the investigator.
4. 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).
5. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
6. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver, or kidney) with the exception of controlled thyroid function disease.
7. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary, or hypothalamus which would contraindicate the use of gonadotropins.
8. 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.
9. Currently breast-feeding.
10. Undiagnosed vaginal bleeding.
11. 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.
12. Pregnancy (negative urinary pregnancy tests must be documented at screening and before randomisation) or contraindication to pregnancy.
13. Use of fertility modifiers during the last menstrual cycle before screening, including dehydroepiandrosterone (DHEA) and metformin or cycle programming with oral contraceptives, progestogen, or estrogen preparations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; Placebo from day 1 to end of stimulation	Drug: Follitropin delta; The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.; Other Names: REKOVELLE; Drug: Placebo FE 999302; No active ingredient, subcutaneous injection.
Active Comparator: FE 999302 Group; FE 999302 from stimulation day 1 to end-of-stimulation	Drug: Follitropin delta; The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.; Other Names: REKOVELLE; Drug: FE 999302; 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
Active Comparator: FE 999302 and Placebo Group; FE 999302 from stimulation day 1 to stimulation day 5, and placebo stimulation day 6 to end-of-stimulation	Drug: Follitropin delta; The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.; Other Names: REKOVELLE; Drug: Placebo FE 999302; No active ingredient, subcutaneous injection.; Drug: FE 999302; 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
Active Comparator: Placebo and FE 999302; Placebo from stimulation day 1 to stimulation 5, FE 999302 from stimulation day 6 to end-of-stimulation.	Drug: Follitropin delta; The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.; Other Names: REKOVELLE; Drug: Placebo FE 999302; No active ingredient, subcutaneous injection.; Drug: FE 999302; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of good-quality blastocysts	Number of good-quality blastocysts on day 5 after oocyte retrieval	Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of metaphase II oocytes	Number of metaphase II (MII) oocytes	Up to 22 days
Number of fertilised oocytes	Number of fertilised (2 pronuclei [2PN]) oocytes	Up to 22 days
Number of blastocysts	Number of blastocysts	Up to 27 days
Number of cryopreserved blastocysts	Number of cryopreserved blastocysts	Up to 28 days
Number and Size of Follicles	Number of follicles by size category on stimulation day 5 and at end-of-stimulation	Day 5 and up to 20 days
Serum hormone concentrations	Serum hormone concentrations of progesterone, androstenedione, estradiol, inhibin B, and luteinising hormone (LH).	Day 5, up to 20 days, and up to 22 days
Number of Stimulation Days	Number of stimulation days	Up to 20 days
Number of Oocytes	Number of oocytes retrieved	Up to 22 days
Endometrial thickness	Endometrial thickness	Up to 20 days and up to 27 days
Positive βhCG	Positive βhCG	13-15 days after fresh transfer
Clinical pregnancy	Clinical pregnancy measured by at least one gestational sac 5-6 weeks after fresh transfer	5-6 weeks after fresh transfer
Vital pregnancy	Vital pregnancy measured by at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after fresh transfer	5-6 weeks after fresh transfer
Ongoing pregnancy	Ongoing pregnancy measured by at least one intrauterine viable fetus 10-11 weeks after fresh transfer	10-11 weeks after fresh transfer

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Ferring Pharmaceuticals, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): October 16, 2025
• Study Completion (Actual): October 16, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; follitropin delta
• Other Study ID Numbers: 000427; 2023-508149-42-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No