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

Fertility Clinical Trial

— Celestial-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06466486
• Other study ID #: 000426
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 11, 2024
• Est. completion date: September 11, 2027

Study information

• Verified date: June 2024
• Source: Ferring Pharmaceuticals
• Contact: Global Clinical Compliance
• Phone: +1 862-286-5200
• Email: Disclosure[@]ferring.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: September 11, 2027
• Est. primary completion date: November 11, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 screening, including dehydroepiandrosterone (DHEA) and metformin or cycle programming with oral contraceptives, progestogen, or estrogen preparations

Related Conditions & MeSH terms

• Fertility

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and Quality of blastocysts	The number of good-quality blastocysts	Day 5 after oocyte retrieval.
Secondary	Number and size of follicles	Number of follicles by size category	On stimulation day 6 and up to 20 days
Secondary	Serum hormone concentrations	Serum hormone concentrations of progesterone, androstenedione, estradiol, inhibin B, and luteinising hormone (LH)	On stimulation day 6, up to 20 days, and up to 22 days
Secondary	Number of Stimulation days	Number of stimulation days	Up to 20 days
Secondary	Number of oocytes	Number of oocytes retrieved	Up to 22 days
Secondary	Number of metaphase II oocytes	Number of metaphase II (MII) oocytes	Up to 22 days
Secondary	Number of fertilised oocytes	Number of fertilised (2 pronuclei [2PN]) oocytes	Up to 22 days
Secondary	Number of blastocysts	Number of blastocysts	Up to 27 days
Secondary	Number of cryopreserved blastocysts	Number of cryopreserved blastocysts	Up to 28 days
Secondary	Endometrial thickness	Endometrial thickness	Up to 20 days, and up to 27 days
Secondary	Positive ßhCG	Positive ßhCG (positive serum ßhCG test )	13 to 15 days after fresh transfer
Secondary	Clinical pregnancy	Clinical pregnancy (at least one gestational sac)	5-6 weeks after fresh transfer
Secondary	Vital pregnancy	Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat)	5-6 weeks after fresh transfer
Secondary	Ongoing pregnancy	Ongoing pregnancy (at least one intrauterine viable fetus)	10-11 weeks after fresh transfer