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Active, not recruitingNCT06921395Updated Sep 2, 2026

Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulation in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer (IVF-ET).

A Phase 4 interventional study of Fang Le Shu (Follitrope) and Guo Na Fen (Gonal-F) in Female Infertility, sponsored by LG Chem. Active, not recruiting at 1 site in China. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by LG Chem · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
248
Allocation
Randomized
Ages
20 Years to 39 Years
Sex
Female
01

Study summary

The aim of this randomized, open-label, active-controlled, parallel-group, multicenter, phase IV study is to assess the efficacy and safety of Fang Le Shu versus Guo Na Fen used for controlled ovarian stimulation in infertile women undergoing In Vitro Fertilization-Embryo Transfer.

02

Conditions studied

  • Female Infertility

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03

In context

Infertility, Female

540 studies on the registry are indexed under Infertility, Female; 138 are open to participants now.

This study's planned enrollment of 248 is above the median of 100 across 371 interventional studies indexed under Infertility, Female.

Browse Infertility, Female studies →

Lead sponsor

LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Is pre-menopausal female aged ≥20 to \<40 years.
  • Has regular menstrual cycles of ≥25 to ≤35 days.
  • Has Normal baseline serum FSH, LH, E2, P4.
  • Is able to voluntarily sign the informed consent form (ICF).
  • Has history of infertility for at least 1 year before the day of randomization; however, subjects with confirmed diagnosis of infertility are eligible without fulfilling the 1-year requirement.

Exclusion criteria

Exclusion Criteria:

  • Has any known clinically significant major systemic disease, or endocrine or metabolic abnormalities with the exception of controlled thyroid function disease.
  • Has body mass index (BMI) of >30 kg/m2.
  • Has clinically significant abnormalities of the uterus, ovary, or appendix prior to the day of randomization
  • Has history of surgeries that may affect oocyte retrieval or pregnancy outcome, such as surgical resection of uterine mediastinum, fibroids, or cysts (however, patients who received polypectomy are allowed to enroll).
  • Has history of severe ovarian hyperstimulation syndrome (OHSS) defined as Grade 4 or higher.
  • Poor ovarian reponder according to Bologna criteria
  • Has plans to donate oocyte or recieve embryo from another women or undergo preimplantation genetic testing(PGT)
  • Has history of three or more failures in previous IVF cycles
  • Has history of recurrent miscarriage
  • Has known current active pelvic inflammatory disease.
  • Is currently breastfeeding.
  • Has a contraindication to pregnancy that would preclude participation in the trial.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
248 participants (estimated)

Study arms

  • Experimental
    Fang Le Shu

    Fang Le Shu

    Drug: Fang Le Shu (Follitrope)

  • Active comparator
    Guo Na Fen

    Guo Na Fen

    Drug: Guo Na Fen (Gonal-F)

Interventions

  • DrugFang Le Shu (Follitrope)

    rFSH 150 IU, 225 IU, 300 IU per syringe

  • DrugGuo Na Fen (Gonal-F)

    rFSH 450 IU per pen

06

What researchers measure

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: 36 ± 3 hours after HGC trigger

Secondary outcomes

  1. High quality embryo rate

    Time frame: 3 days after oocyte retrieval

  2. Biochemical pregnancy rate

    Time frame: 14 days after embryo transfer

  3. Clinical pregnancy rate

    Time frame: 5 weeks after embryo transfer

  4. Ongoing pregnancy rate

    Time frame: 10 weeks after embryo transfer

  5. Miscarriage rate

    Time frame: 28 weeks of gestation

  6. Live birth rate

    Time frame: 40 weeks of gestation

07

Study locations

1 site
  • The first affiliated hospital of Zhengzhou University
    Zhengzhou, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06921395
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
Apr 10, 2025
Start date
Feb 15, 2025
Primary completion
Dec 26, 2025
Completion
Oct 2026 (estimated)
Last update
Sep 2, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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