infertility
Conditions
Interventions
experiment group:recombinant human follicle-stimulating hormone -CTP fusion protein injection +Recombinant Human Follitropin Alfa Solution for Injection
control group:Recombinant Human Follitropin Alfa Solution for Injection
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily signed an informed consent form (ICF); 2. Those who plan to carry out ART techniques such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) and need COH; The age is 20-35 years old (excluding 35 years old, calculated according to the date of signing ICF MINUS the birthday of the subject); 3. Body weight >= 45.0 kg, BMI 18.5~28.0 kg/m2 (including boundary value); 4. Regular menstrual cycle (25 ~ 34 days) in the first 3 months before signing ICF; 5. At the time of screening, FSH, E2, progesterone (P), luteinizing hormone (LH), prolactin (PRL), total testosterone (T) and thyroid-stimulating hormone (TSH) were within the normal range of clinical laboratory, or abnormal but the researchers thought they had no clinical significance.
Exclusion criteria
Exclusion criteria: 1. In the past, the number of oocyte retrieval cycles by ART technique was >= 2; 2. Patients with recurrent abortion have had spontaneous abortion >= 3 times in the past; 3. The researcher judges that there is a high risk of OHSS (such as those with moderate to severe OHSS in COH, polycystic ovary syndrome (PCOS), and those who cancel the cycle due to OHSS in the past); 4. Those with low ovarian function showed at least one of the following: poor ovarian response in the past (the number of oocyte obtained by conventional enough Gn stimulation program in the past was 4 cm, bilateral or one ovary unable to take eggs) or abnormal accessories (such as hydrosalpinx) when entering the group; 12. It is known that abnormal cervical cytology with clinical significance has been observed within one year before randomization (unless the clinical significance has been resolved). 13. Patients with unexplained abnormal uterine bleeding; 14. Have a history of malignant tumors such as ovary, breast, uterus, hypothalamus and pituitary gland; 15. Known past or present thromboembolic diseases; 16. Those who suffer from known severe mental illness or cannot understand the purpose and method of this clinical trial, and do not comply with the research procedures; 17. those who have contraindications or have a history of allergy to recombinant human follicle stimulating hormone -CTP fusion protein injection, GnRH-ant, rhFSH, recombinant human chorionic gonadotropin (rhCG) and progesterone drugs; 18. Those who have bad habits of alcoholism, tobacco addiction, drug abuse and drug abuse; 19. Exposure to teratogenic rays, poisons, and drugs is in the action period; 20. The blood alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are higher than the upper limit of normal value by 2 times; 21. The serum creatinine (Cr) is higher than the upper limit of normal value; 22. Positive for HIV or syphilis; Patients with hepatitis B, hepatitis C and tuberculosis, after standardized treatment, the researchers believe that those who meet the ART requirements can join the group; 23 serum pregnancy test was positive; 24. The subject needs testicular sperm for sperm donation, su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of oocytes retrieved;Safety evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Estradiol;FSH;inhibin b;Follicle development;High-quality embryo rate;Biochemical pregnancy rate;Implantation rate;The clinical pregnancy rate;Survival pregnancy rate;The ongoing pregnancy rate;Population pharmacokinetic evaluation; | — |
Countries
China
Contacts
Public ContactZhu Zhen
Suzhou Centergene Pharmaceuticals Co.,Ltd.
Outcome results
None listed