Infertility
Conditions
Interventions
Experimental Group:Subcutaneous injection of Fangleshu
Comparator group:Subcutaneous injection of Gonafine
Sponsors
The first affiliated hospital of zhengzhou university
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Premenopausal women aged between 20 and 40. 2. The menstrual cycle is regular, ranging from 25 days to 35 days. 3. The baseline serum levels of follicle-stimulating hormone (FSH < 10 mIU/mL), luteinizing hormone (LH), estradiol (E2), and progesterone (P4) were normal. 4. Have indications for in vitro fertilization-embryo transfer (IVF-ET) and meet any of the following conditions: a. Tubal infertility; b. Unexplained infertility; c. The partner has been diagnosed with male infertility. 5. Be able to voluntarily sign the Informed Consent Form (ICF). 6. At least one year of infertility history prior to the randomization date; However, subjects who have been diagnosed with infertility do not have to meet the one-year requirement.
Exclusion criteria
Exclusion criteria: 1. Suffering from any major systemic disease or endocrine or metabolic disorder of known clinical significance, excluding controlled thyroid dysfunction. 2. Body mass Index (BMI) > 30 kg/m^2. 3. Before randomization, there were clinically significant abnormalities in the uterus (with a diameter of >=2 cm or uterine fibroids affecting the endometrium; endometrial polyps; intrauterine adhesions; uterine malformations), ovaries (ovarian cysts or polycystic ovary syndrome [PCOS]), or adnexa (hydrosalpinx). 4. Surgical history that may affect oocyte retrieval or pregnancy outcomes, such as history of uterine septum, fibroid and cyst resection (but patients with a history of polyp resection can be included). 5. Have a history of severe ovarian hyperstimulation syndrome (OHSS) of grade 4 or above. 6. Previous gonadotropin treatment for low ovarian response (POR), with evidence of at least two of the following conditions: a. Elderly women (aged 40 or above) or any other risk factors for POR; b. There has been a history of POR (the number of oocytes obtained using conventional stimulation protocols is less than or equal to 3); c. Abnormal ovarian reserve test, that is, bilateral antral follicle count (AFC) <=4 or anti-Mullerian hormone (AMH) <=0.5 ng/mL. 7. There is abnormal uterine bleeding of unknown cause. 8. Plan to donate oocytes or accept embryos from other women, or undergo preimplantation genetic testing (PGT). 9. The test results for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or syphilis are positive. HCV test results within six months are acceptable. 10. There is past or current evidence indicating that the subject has any mental disorder that affects their ability to understand the purpose of the study and agree to comply with the requirements of the study assessment/procedures. 11. There is evidence of habitual drinking, drug abuse or heavy smoking. 12. There is contraindication or a known history of allergy to Fangleshu, Gonafin or other recombinant follicle-stimulating hormone (rFSH) preparations and/or excipients in their formulations. 13. Those who plan to participate in the trials of other investigational drugs or devices after being enrolled in this study, or have participated in the trials within three months prior to the date of randomization. 14. Known to have malignant or benign tumors of the ovary, uterus, breast, pituitary gland or hypothalamus. 15. Have a history of three or more failed IVF cycles. 16. Ovulation-inducing drugs such as clomiphene, letrozole or gonadotropins were used in the menstrual cycle prior to the IVF cycle in this study, or it is planned to use the above-mentioned non-study drugs during the study period. 17. A history of recurrent miscarriage is known and defined as three consecutive miscarriages from the time of pregnancy confirmed by ultrasound (excluding ectopic pregnancy) to before 24 weeks of pregnancy. 18. The subject's medical history indicates the known presence of anti-FSH antibodies. Anti-fsh antibody detection was not conducted in this study. 19. It is known that the current patient has active pelvic inflammatory disease. 20. Currently in the lactation period. 21. There are contraindications for pregnancy that prevent participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of oocytes retrieved; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of metaphase II oocytes (only applicable for those undergoing intracytoplasmic sperm injection);Total rFSH dose (IU) and duration of stimulation (days);Number of follicles with diameter >=14 mm on the hCG day;Circulating concentration of estradiol (E2) on the hCG day;Circulating concentration of progesterone (P4) on the hCG day;High quality embryo rate;Endometrial thickness (in mm) on the hCG day;Fertilization rate;Number of embryos transferred;Implantation rate;Biochemical pregnancy rate;Clinical pregnancy rate;Ongoing pregnancy rate;Miscarriage rate;Live birth rate;Adverse events (AEs);Ovarian hyperstimulation syndrome (OHSS); | — |
Countries
China
Contacts
Public ContactYingpu Sun
The first affiliated hospital of zhengzhou university
Outcome results
None listed