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To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference

NCT06091436 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2024-12-03

No results posted yet for this study

Summary

To investigate the efficacy and safety of a single injection of GenSci094 to induce multi-follicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of GenSci094 is non-inferior to daily treatment with recFSH in initiating multi-follicular growth.

Conditions

Interventions

DRUG

GenSci094

On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection of 150 μg or 100μg (0.5 mL) GenSci094 was administered in the abdominal wall.

DRUG

Placebo RecFSH / follitropin alfa

powder-injection, but without the active ingedient, SC injection . Daily SC injections were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

BIOLOGICAL

Biological: RecFSH / Follitropin alfa (Days 1 to 7)

Daily SC injections with 150IU or 225IU recFSH were started on Stimulation Day 1 and continued up to and including Stimulation Day 7.

DRUG

Placebo GenSci094

Pre-filled syringe containing an identical solution when compared to GenSci094. On the morning of day 2 or 3 of the menstrual cycle (Stimulation Day 1), a single SC injection was administered in the abdominal wall.

BIOLOGICAL

RecFSH / Follitropin alfa (Days 8 to hCG)

From Stimulation Day 8 onwards a daily SC dose 75IU～300 IU recFSH was administered up to and including the Day of hCG.

DRUG

Ganirelix

On Stimulation Day 5 a daily SC injection of 0.25 mg was started, which continued up to and including the day of hCG

BIOLOGICAL

hCG

When 3 follicles \>= 17 mm were observed by USS, a single dose of 10,000 IU/USP hCG was administered; or, for those at risk for Ovarian Hyperstimulation Syndrome (OHSS), a lower dose of 5,000 IU/USP

DRUG

Progesterone

On the day of OPU, luteal phase support was started by administering micronized progesterone of at least 400 mg/day vaginally, and 40mg/d oral, which continued for at least 6 weeks, or up to menses.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • xiaoyan liang, doctor · The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong Gastrointestinal Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2023-12-25
Completion
2024-01-29

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT06091436 on ClinicalTrials.gov