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.

Start Date15 Jul 2024

Sponsor / Collaborator

Ferring Pharmaceuticals SA

NCT06466486

/ TerminatedPhase 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.

Start Date14 Jun 2024

Sponsor / Collaborator

Ferring Pharmaceuticals SA

NCT05571111

/ WithdrawnPhase 2

A Randomised, Assessor-blind, Active-controlled, Parallel-group, Dose-finding Trial to Investigate the Efficacy and Safety of FE 999302 for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation

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.

Start Date04 Oct 2022

Sponsor / Collaborator

Ferring Pharmaceuticals A/S

100 Clinical Results associated with Choriogonadotropin beta

100 Translational Medicine associated with Choriogonadotropin beta

100 Patents (Medical) associated with Choriogonadotropin beta

Literatures (Medical) associated with Choriogonadotropin beta

30 May 2022·HUMAN REPRODUCTIONQ1 · MEDICINE

A randomized, controlled, first-in-patient trial of choriogonadotropin beta added to follitropin delta in women undergoing ovarian stimulation in a long GnRH agonist protocol

Q1 · MEDICINE

Article

Author: Christophe Blockeel ; Milan Mrazek GYNEM ; Claus Yding Andersen ; Juan Antonio Garcia Velasco ; Milan Kafka ; Andrew Drakeley ; Ales Sobek ; Per Larsson ; Petra de Sutter ; Nina La Cour Freiesleben ; Petr Uher ; Marcos Ferrando ; Merete Husth ; Hana Višnová ; Victoria Verdu ; Scott Nelson ; Marco Filicori ; Anja Pinborg ; Ursula Bentin-Ley ; Yacoub Khalaf ; Bernadette Mannaerts ; Pedro Barri ; Ernesto Bosch ; Manuel Fernández Sánchez ; Nitish Narvekar

Abstract:

STUDY QUESTION:

Does addition of choriogonadotropin beta (recombinant CG beta) to follitropin delta increase the number of good-quality blastocysts following ovarian stimulation in a long GnRH agonist protocol?

SUMMARY ANSWER:

At the doses investigated, the addition of CG beta reduced the number of intermediate follicles and related down-stream parameters including the number of oocytes and blastocysts.

WHAT IS KNOWN ALREADY:

CG beta is a novel recombinant hCG (rhCG) molecule expressed by a human cell line (PER.C6®) and has a different glycosylation profile compared to urinary hCG or rhCG derived from a Chinese Hamster Ovary (CHO) cell line. In the first-in-human trial, the CG beta pharmacokinetics were similar between men and women. In women, the AUC and the peak serum concentration (Cmax) increased approximately dose proportionally following single and multiple daily doses. In men, a single dose of CG beta provided higher exposure with a longer half-life and proportionately higher testosterone production than CHO cell-derived rhCG.

STUDY DESIGN, SIZE, DURATION:

This placebo-controlled, double-blind, randomized trial (RAINBOW) was conducted in five European countries to explore the efficacy and safety of CG beta as add-on treatment to follitropin delta in women undergoing ovarian stimulation in a long GnRH agonist protocol. Randomization was stratified by centre and age (30–37 and 38–42 years). The primary endpoint was the number of good-quality blastocysts (Grade 3 BB or higher). Subjects were randomized to receive either placebo or 1, 2, 4, 8 or 12 µg CG beta added to the daily individualized follitropin delta dose during ovarian stimulation.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

In total, 620 women (30–42 years) with anti-Müllerian hormone (AMH) levels between 5 and 35 pmol/l were randomized in equal proportions to the six treatment groups and 619 subjects started treatment. All 619 subjects were treated with an individualized dose of follitropin delta determined based on AMH (Elecsys AMH Plus Immunoassay) and body weight. Triggering with rhCG was performed when 3 follicles were ≥17 mm but no more than 25 follicles ≥12 mm were reached.

MAIN RESULTS AND THE ROLE OF CHANCE:

The demographic characteristics were comparable between the six treatment groups and the overall mean age, body weight and AMH were 35.6 ± 3.3 years, 65.3 ± 10.7 kg and 15.3 ± 7.0 pmol/l, respectively. The incidence of cycle cancellation (range 0–2.9%), total follitropin delta dose (mean 112 µg) and duration of stimulation (mean 10 days) were similar across the groups. At stimulation Day 6, the number and size of follicles was similar between the treatment groups, whereas at the end-of-stimulation dose-related decrease of the intermediate follicles between 12 and 17 mm was observed in comparison to the placebo group. In contrast, the number of follicles ≥17 mm was similar between the CG beta dose groups and the placebo group. A reduced number of intermediate follicles (12 to 17 mm) and fewer oocytes (mean range 9.7 to 11.2) were observed for all doses of CG beta compared to the follitropin delta only group (mean 12.5). The mean number of good-quality blastocysts was 3.3 in the follitropin delta group and ranged between 2.1 and 3.0 across the CG beta groups. The incidence of transfer cancellation was higher in the 4, 8 and 12 µg group, mostly as no blastocyst was available for transfer. In the group receiving only follitropin delta, the ongoing pregnancy rate (10–11 weeks after transfer) was 43% per started cycle versus 28–39% in CG beta groups and 49% per transfer versus 38–50% in the CG beta groups. There was no apparent effect of CG beta on the incidence of adverse events, which was 48.1% in the placebo group and 39.6–52.3% in the CG beta dose groups. In line with the number of collected oocytes, the overall ovarian hyperstimulation syndrome incidence remained lower following follitropin delta with CG beta (2.0–10.3%) compared with follitropin delta only treatment (11.5%). Regardless of the dose, CG beta was safe and well-tolerated with low risk of immunogenicity.

LIMITATIONS, REASONS FOR CAUTION:

The effect of the unique glycosylation of CG beta and its associated potency implications in women were not known prior to this trial. Further studies will be needed to evaluate optimal doses of CG beta for this and/or different indications.

WIDER IMPLICATIONS OF THE FINDINGS:

The high ongoing pregnancy rate in the follitropin delta group supports the use of individualized follitropin delta dosing in a long GnRH agonist protocol. The addition of CG beta reduced the presence of intermediate follicles with the investigated doses and negatively affected all down-stream parameters. Further clinical research will be needed to assess the optimal dose of CG beta in the optimal ratio to follitropin delta to develop this novel combination product containing both FSH and LH activity for ovarian stimulation.

STUDY FUNDING/COMPETING INTEREST(S):

The study was funded by Ferring Pharmaceuticals, Copenhagen, Denmark. B.M. and P.L. are employees of Ferring Pharmaceuticals. M.F.S., H.V., C.Y.A., M.F., C.B., A.P. and Y.K. have received institutional clinical trial fees from Ferring Pharmaceuticals. C.B. has received payments for lectures from Organon, Ferring Pharmaceuticals, Merck A/S and Abbott. M.F.S. has received payment for lectures from Ferring Pharmaceuticals. Y.K. has received payment for lectures from Merck and travel support from Gedeon Richter. H.V. has received consulting fees from Oxo and Obseva and travel support from Gedeon Richter, Ferring Pharmaceuticals and Merck. C.Y.A. has received payment for lectures from IBSA, Switzerland. M.F and C.Y.A. were reimbursed as members of the Data Monitoring Board in this trial. M.F. has an issued patent about unitary combination of FSH and hCG (EP1633389).

TRIAL REGISTRATION NUMBER:

2017-003810-13 (EudraCT Number)

TRIAL REGISTRATION DATE:

21 May 2018

DATE OF FIRST PATIENT’S ENROLMENT:

13 June 2018

01 Jul 2021·Clinical and translational scienceQ3 · MEDICINE

First‐in‐human trial assessing the pharmacokinetic‐pharmacodynamic profile of a novel recombinant human chorionic gonadotropin in healthy women and men of reproductive age

Q3 · MEDICINE

ArticleOA

Author: Larsson, Per ; Mannaerts, Bernadette ; Broksø Kyhl, Lars‐Erik ; Bruzelius, Katharina ; Hesse, Christiane

Abstract:

The purpose of this first‐in‐human trial was to examine the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of a novel recombinant human chorionic gonadotropin (rhCG; FE 999302, choriogonadotropin beta) to support its clinical development for various therapeutic indications. The single and multiple dose PK of choriogonadotropin beta (CG beta) were evaluated in women and the single dose PK and PD of CG beta were compared to those of CG alfa in men. CG beta was safe and well‐tolerated in all 84 healthy subjects. In women, the area under the curve (AUC) and the peak serum concentration (Cmax) increased approximately dose proportionally following single and multiple doses of CG beta. The apparent clearance (CL/F) was ~ 0.5 L/h, the mean terminal half‐life (t½) ~ 45 h and the apparent distribution volume (Vz/F) ~ 30 L. After single administration in men, the mean AUC was 1.5‐fold greater for CG beta than for CG alfa. Mean Cmax and Vz/F were comparable for the 2 preparations. In accordance with the differences in AUC, the CL/F was lower for CG beta (CL/F 0.5 vs. 0.8 L/h), explained by a longer t½ (47 vs. 32 h). Serum testosterone levels induced by a single dose rhCG reflected the PK profiles with a slight delay, resulting in 59% higher AUC for CG beta. The PK parameters for CG beta were comparable in men and in women. In conclusion, the PK differs between the two rhCG preparations, causing higher exposure and a higher PD response for CG beta, which may require relatively lower therapeutic doses.

01 Jul 1982·Clinical chemistryQ1 · MEDICINE

Plasma hormone concentrations and serum 17 beta-hydroxysteroid dehydrogenase activity in molar pregnancy.

Q1 · MEDICINE

Article

Author: Le Pogamp, Catherine ; Nicol, Marc ; Massart, Catherine

Abstract:

Concentrations of unconjugated 17 beta-estradiol, estrone, and estriol, and of progesterone, 17 alpha-hydroxyprogesterone, testosterone, delta 4-androstenedione, dehydroepiandrosterone sulfate (DHEAS), choriogonadotropin beta-subunit, and prolactin were measured by radioimmunoassay in plasma of six patients with molar pregnancies of seven to 15 weeks of gestation. Serum 17 beta-hydroxysteroid dehydrogenase (EC 1.1.1.6.2) activity was also determined. Estriol was not detected in any of the six women. Values for DHEAS and progesterone were normal, except for one patient who had above-normal plasma progesterone. Values for the other hormones and the enzyme were within normal limits in very early intact molar pregnancies, but were above normal limits in more advanced cases. A close correlation was seen between 17 beta-hydroxysteroid dehydrogenase activity and concentrations of estradiol, estrone, testosterone, and 17 alpha-hydroxyprogesterone; the last four also correlated significantly with beta-choriogonadotropin in molar pregnancies, whether benign or invasive. Benign trophoblastic disease showed significant correlation of progesterone with beta-choriogonadotropin and with estradiol. We conclude that the estradiol, estrone, testosterone, and 17 alpha-hydroxyprogesterone were principally derived from molar tissue.

News (Medical) associated with Choriogonadotropin beta

02 Apr 2026

·www.fiercebiotech.com

‘Portfolio assessment’ prompts Ferring to terminate 2 fertility trials

With the newly terminated trials, Ferring seems to have no ongoing clinical work in reproductive medicine save for an observational study of Rekovelle in Asian countries.\n Ferring Pharmaceuticals is halting work on two trials of a phase 1 infertility candidate that together had enrolled 416 patients. The Celestial-1 and Celestial-2 trials, testing the pairing of choriogonadotropin beta (coded as FE999302) with Ferring’s own approved fertility med Rekovelle, have been terminated as part of “a broader portfolio assessment,” according to a notice in the federal clinical trial database. The decision was not the result of any safety concerns, the notice says.The Celestial trials were testing whether FE999302 could improve pregnancy rates when combined with Rekovelle, which is a form of follicle-stimulating hormone.The decision reflects “the desire to focus on programs that can bring timely and meaningful benefit to patients,” Ferring wrote in the database.“We continuously assess and prioritize our pipeline,” a Ferring spokesperson told Fierce Biotech, noting that the terminations are not related to the Swiss pharma’s reorganization last October. Ferring laid off 500 employees, around 7% of its workforce, as part of that streamlining.The spokesperson did not respond to follow-up questions from Fierce on the status of FE999302 going forward.Those October job cuts were meant to align with Ferring’s so-called Enterprise Model to “sharpen strategic focus, improve cost efficiencies, flexibility, and free up resources for reinvestment in innovation, whilst promoting [Ferring’s] financial stability and sustainable growth,” the company said at the time.Not long after announcing the workforce reduction, Ferring revealed it was slowing down commercial efforts for Rebyota, the first fecal microbiota product to be approved by the FDA, as it explored strategic options for the drug.These decisions followed an earlier layoff round and the shuttering of a research site in 2023. With the newly terminated trials, Ferring appears to have no ongoing clinical work in reproductive medicine, save for an observational study of Rekovelle in Asian countries. Several infertility studies listed in the company’s pipeline have been completed.Additionally, a study testing Rekovelle’s ability to improve male fertility, called Adam, was scrapped in 2024 due to slow enrollment, while an investigational treatment for inadequate milk production vanished from the pipeline in 2023.When canceling Adam, Ferring said that the move “was not due to safety concerns nor changes in Ferring\'s reproductive medicine strategy or interest in developing treatments for male infertility,” according to the clinical trial database.Ferring reported record revenue of more than 2.5 billion euros in 2025, largely powered by the pharma’s flagship fertility drug Menopur.

Phase 1

100 Deals associated with Choriogonadotropin beta

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Female infertility of tubal origin	Phase 2	Spain	Ferring Pharmaceuticals A/S	04 Oct 2022
Infertility, Male	Phase 2	Spain	Ferring Pharmaceuticals A/S	04 Oct 2022
Infertility	Phase 2	Denmark	Ferring Pharmaceuticals SA	08 Apr 2018

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