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NCT Number: NCT06921395

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).

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.

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Key information

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

The first affiliated hospital of Zhengzhou University

Zhengzhou, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Fang Le Shu (Follitrope)

Drug

rFSH 150 IU, 225 IU, 300 IU per syringe

Guo Na Fen (Gonal-F)

Drug

rFSH 450 IU per pen

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

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Study Lead

CONTACT

[email protected]

+82-2-6987-4147

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study title

A Phase IV, Prospective, Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Evaluate Efficacy and Safety of Fang Le Shu (Recombinant FSH) Versus Guo Na Fen Used for Controlled Ovarian Stimulation in Infertile Women Undergoing In Vitro Fertilization-Embryo Transfer.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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