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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2026-02-12

Study results available
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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

Interventions

DRUG

FE 999049

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.

DRUG

GONAL-F

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.

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-29
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06173869 on ClinicalTrials.gov