A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China

NCT06173869 | Completed Phase 3 Results

• 1 other identifier: 000413
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 11

Brief Summary

This is a phase 3b clinical trial with follitropin delta (FE 999049) and Gonal-F. The trial is a randomised, controlled, assessor-blind, parallel groups, multicentre trial comparing the ovarian response of a starting dose of either 10mg or 15 mg follitropin delta to a starting dose of either 150 IU or 225 IU Gonal-F in a long GnRH agonist protocol in women undergoing an assisted reproductive technology programme in China.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• Number of Oocytes Retrieved

  On day of oocyte retrieval (up to 22 days after start of stimulation)

Secondary Outcomes (15)

• Number of Follicles on Stimulation Day 6 and End-of-stimulation

  Stimulation day 6 and end-of-stimulation (maximum stimulation day 20)

• Serum Concentrations of Estradiol on Stimulation Day 6 and End-of-stimulation

  stimulation day 6 and end-of-stimulation (maximum stimulation day 20)

• Serum Concentrations of Progesterone on Stimulation Day 6 and End-of-stimulation

  stimulation day 6 and end-of-stimulation (maximum stimulation day 20)

• Number of Fertilised Oocytes

  On day 1 after oocyte retrieval (up to 23 days after start of stimulation)

• Fertilisation Rate

  On day 1 after oocyte retrieval (up to 23 days after start of stimulation)

Study Arms (2)

FE 999049

EXPERIMENTAL

The participants receive either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg

Drug: FE 999049

GONAL-F

ACTIVE COMPARATOR

The participants receive either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU.

Drug: GONAL-F

Interventions

FE 999049 DRUG

FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose could be increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants could be treated for a maximum of 20 days.

Also known as: Rekovelle, Follitropin Delta

FE 999049

GONAL-F DRUG

GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose could be increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants could be treated for a maximum of 20 days. Coasting was not allowed.

GONAL-F

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated Informed Consent Form for participation in the trial, obtained before any trial-related procedures.
• In good physical and mental health in the judgement of the investigator.
• Chinese pre-menopausal female between the ages of 20 and 40 years; at least 20 years (including the 20th birthday) when signing the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomisation.
• Eligible for ovarian stimulation with a dose equivalent to 150 IU GONAL-F or 225 IU GONAL-F, as judged by the investigator.
• Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.
• 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) or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor
• Infertility for at least one year before randomisation for subjects \<35 years or for at least 6 months for subjects ≥35 years (criteria not applicable in case of tubal or severe male factor infertility).
• Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
• Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality. Both ovaries must be accessible for oocyte retrieval.
• Early follicular phase (cycle day 2-4) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (results obtained within 3 months prior to randomisation).
• Serum anti-Müllerian hormone (AMH) concentration of ≤35 pmol/L at screening.

You may not qualify if:

• Primary ovarian failure.
• More than three previous controlled ovarian stimulation cycles initiated, regardless of outcome.
• History of previous episode of OHSS, exuberant ovarian response to gonadotropins, or polycystic ovarian syndrome.
• Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial 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.
• Fibroid tumours of the uterus incompatible with pregnancy.
• Currently breast-feeding.
• Known inherited or acquired thrombophilia disease.
• Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
• Known porphyria.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (11)

Ferring Investigational Site

Shushan, Anhui, 230032, China

Location

Ferring Investigational Site

Yuzhong, Chongqing Municipality, 401147, China

Location

Ferring Investigational Site

Guangzhou, Guandong, 510120, China

Location

Ferring Investigational Site

Guangzhou, Guangdong, 510000, China

Location

Ferring Investigational Site

Zhengzhou, Henan, China

Location

Ferring Investigational Site

Nanchang, Jiangxi, 330038, China

Location

Ferring Investigational Site

Shengyang, Liaoling, 110004, China

Location

Ferring Investigational Site

Shanghai, Shanghai Municipality, 201204, China

Location

Ferring Investigational Site

Chengdu, Sichuang, 610041, China

Location

Ferring Investigational Site

Tianjin, Tianjin Municipality, 300052, China

Location

Ferring Investigational Site

Xiaobailou, Tianjin Municipality, 300052, China

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

FE 999049; follitropin delta; follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

disclosure@ferring.com

+1 833-548-1402

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 18, 2023
• Study Start: March 29, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)