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).

Официальное название

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.

Обзор

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.

Вмешательства

• Препарат Fang Le Shu (Follitrope)
  rFSH 150 IU, 225 IU, 300 IU per syringe
• Препарат Guo Na Fen (Gonal-F)
  rFSH 450 IU per pen

Первичные конечные точки

• Number of oocytes retrieved [Срок оценки: 36 ± 3 hours after HGC trigger]

Вторичные конечные точки (6)

• High quality embryo rate [Срок оценки: 3 days after oocyte retrieval]
• Biochemical pregnancy rate [Срок оценки: 14 days after embryo transfer]
• Clinical pregnancy rate [Срок оценки: 5 weeks after embryo transfer]
• Ongoing pregnancy rate [Срок оценки: 10 weeks after embryo transfer]
• Miscarriage rate [Срок оценки: 28 weeks of gestation]
• Live birth rate [Срок оценки: 40 weeks of gestation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The first affiliated hospital of Zhengzhou University — Чжэнчжоу

Идентификаторы

NCT: NCT06921395 · LG-FSCL006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗