BridgeMD
Compares treatment options for Female Infertility
Official title 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).
ClinicalTrials.gov ID: NCT06921395
What this study is testing
What is Fang Le Shu (Follitrope)?
Fang Le Shu (Follitrope) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for female infertility.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 39, women only
You may be able to join if
- 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, people with confirmed diagnosis of infertility are eligible...
You likely can't join if
- Has any known clinically significant major systemic disease, or endocrine or metabolic abnormalities with the exception of controlled thyroid...
- 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...
- Has history of severe ovarian hyperstimulation syndrome (OHSS) defined as Grade 4 or higher.
- Poor ovarian reponder according to Bologna criteria
See the full eligibility 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, people with confirmed diagnosis of infertility are eligible without fulfilling the 1-year requirement.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.