An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation (Celestial-1)

A Randomised, Partially Double-blind, Placebo-controlled, Parallel-group Exploratory Trial to Investigate the Effect of FE999302 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 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 Overview

• Status: Terminated
• Conditions: Fertility
• Intervention / Treatment: Drug: Follitropin delta; Drug: FE999302 Placebo; Drug: FE999302

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Ferring Investigational Site
  • Edegem, Belgium, 2650
    • Ferring Investigational Site
• Czechia
  • Prague, Czechia, 184 00
    • Ferring Investigational Site
  • Prague, Czechia, 160 00
    • Ferring Investigational Site
  • Prague
    • Prague, Prague, Czechia, 150 00
      • Ferring Investigational Site
• Denmark
  • Copenhagen, Denmark, 2100
    • Ferring Investigational Site
  • Hvidovre
    • Hvidovre, Hvidovre, Denmark, 2650
      • Ferring Investigational Site
• Norway
  • Bergen, Norway, 5006
    • Ferring Investigational Site
  • Porsgrunn, Norway, 3913
    • Ferring Investigational Site
  • Sor-Trondelag
    • Trondheim, Sor-Trondelag, Norway, 7042
      • Ferring Investigational Site
• Spain
  • Barcelona, Spain, 08028
    • Ferring Investigational Site
  • Madrid, Spain, 28010
    • Ferring Investigational Site
  • Seville, Spain, 41092
    • Ferring Investigational Site
  • Valencia, Spain, 46015
    • Ferring Investigational Site
  • Aravaca
    • Madrid, Aravaca, Spain, 28023
      • Ferring Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

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 15.0-35.0 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 30.0 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 or higher. Poor response is defined as <4 oocytes retrieved, or cycle cancellation before oocyte retrieval due to inadequate follicular development.
3. Excessive ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI using a daily FSH/ human menopausal gonadotropin (hMG) dose of ≤225 IU, defined as ≥25 oocytes retrieved or cycle cancellation before oocyte retrieval due to excessive ovarian response, including risk of ovarian hyperstimulation syndrome (OHSS).
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. Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24 of pregnancy).
6. Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
7. Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver, or kidney) with the exception of controlled thyroid function disease.
8. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary, or hypothalamus which would contraindicate the use of gonadotropins.
9. 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.
10. Currently breast-feeding.
11. Undiagnosed vaginal bleeding.
12. 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.
13. Pregnancy (negative urinary pregnancy tests must be documented at screening and before randomisation) or contraindication to pregnancy.
14. Use of fertility modifiers during the last menstrual cycle before start of stimulation in the trial, 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: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Follitropin delta and FE 999302 placebo	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: FE999302 Placebo; To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
Active Comparator: FE999302 and Placebo Every 2nd Day Group; Follitropin delta and FE 999302 every 2nd day and FE 999302 placebo every 2nd day	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: FE999302 Placebo; To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol; Drug: FE999302; To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
Active Comparator: FE999302 Dose Group 1; Follitropin delta and FE 999302	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: FE999302; To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
Active Comparator: FE999302 Dose Group 2; Follitropin delta and FE 999302	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: FE999302; To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
Placebo Comparator: Placebo Group 2; Follitropin delta and FE 999302 placebo	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: FE999302 Placebo; To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
Active Comparator: FE999302 Dose Group 3; Follitropin delta and FE 999302	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: FE999302; To investigate the effect of FE 999302 on parameters influencing pregnancy rates 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	The number of good-quality blastocysts	Day 5 after oocyte retrieval.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and size of follicles	Number of follicles by size category	On stimulation day 6 and up to 20 days
Number of Stimulation days	Number of stimulation days	Up to 20 days
Number of oocytes	Number of oocytes retrieved	Up to 22 days
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
Endometrial thickness	Endometrial thickness	Up to 20 days, and up to 27 days
Positive βhCG	Positive βhCG (positive serum βhCG test )	13 to 15 days after fresh transfer
Clinical pregnancy	Clinical pregnancy (at least one gestational sac)	5-6 weeks after fresh transfer
Vital pregnancy	Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat)	5-6 weeks after fresh transfer
Ongoing pregnancy	Ongoing pregnancy (at least one intrauterine viable fetus)	10-11 weeks after fresh transfer
Serum hormone concentrations	Serum hormone concentrations of progesterone, 17-OH-progesterone, androstenedione, testosterone, estradiol, inhibin B, and luteinising hormone (LH) on stimulation day 6 and at end of stimulation.	On stimulation day 6, and up to 20 days
Serum hormone concentrations	Serum hormone concentrations of progesterone, 17-OH-progesterone, androstenedione, testosterone, and estradiol at oocyte retrieval	Up to 22 days

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2024
• Primary Completion (Actual): December 3, 2025
• Study Completion (Actual): December 3, 2025

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 20, 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: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; follitropin delta
• Other Study ID Numbers: 000426; 2023-507630-25-00 (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