1.Women with anovulation (including polycystic ovary syndrome [PCOS]) who are unresponsive to clomiphene citrate treatment. 2.Women undergoing controlled ovarian hyperstimulation in assisted reproductive technology (ART) such as in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), and zygote intrafallopian transfer (ZIFT) to stimulate the development of multiple follicles. Patients with severe deficiency of luteinizing hormone (LH) and follicle-stimulating hormone (FSH).
Conditions
Interventions
Experimental group:Recombinant Human Follicle-Stimulating Hormone Injection
Control group:Gonal-f
Sponsors
The first affiliated hospital of Anhui medical university/Peking university third hospita
Eligibility
Sex/Gender
Female
Age
20 Years to 38 Years
Inclusion criteria
Inclusion criteria: In order to be eligible for participation in this study, subjects must meet all of the following inclusion criteria: 1)Couples voluntarily participating in the clinical trial, meeting the requirements of relevant national regulations for assisted reproductive technology, and signing an informed consent form (ICF). 2)Female infertility patients aged 20 to 38 years (including the boundary values). 3)Regular natural menstrual cycles within the range of 24 to 35 days (including the boundary values). 4)Body mass index (BMI), calculated as BMI = weight (kg)/height^2 (m^2), within the range of 18.5 to 28.0 kg/m^2 (including the boundary values). 5)Diagnosed with tubal infertility, unexplained infertility, or male factor infertility in females. 6)The examination results conducted within the 60 days prior to randomization confirmed the following: a.Serum levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), estradiol (E2), progesterone (P), and testosterone (T) on the 2nd to 3rd day of menstruation were within the normal range of the clinical laboratory or, if deemed abnormal by the investigator, were without clinical significance. b.Serum FSH levels were within the range of 1-10 IU/L, and serum E2 levels were =80 pg/ml. c.Serum anti-Mullerian hormone (AMH) levels were =1.2 ng/ml. d.Thyroid-stimulating hormone (TSH) levels were within the normal range of the clinical laboratory or, if deemed abnormal by the investigator, were without clinical significance, or TSH levels were within the normal range after exogenous thyroid hormone treatment. 7)During the early follicular phase, the total number of antral follicles (diameter 2-10mm) in both ovaries is >6 and <24 (as determined during the screening period). 8)Within the past year before screening, one of the following examinations (hysterosalpingography, hysteroscopy, or transvaginal ultrasound) confirmed normal uterine morphology. 9)Within the 60 days prior to screening, transvaginal ultrasound confirmed the presence of both ovaries and uterus and showed sufficient evidence without significant abnormalities. 10)No fertility-regulating agents (e.g., oral contraceptives) were used during the last menstrual cycle prior to screening. 11)Willing to undergo a maximum of two fresh embryo transfers during the study. 12)Willing to use adequate barrier contraceptive methods for contraception or to avoid sexual intercourse during the study period.
Exclusion criteria
Exclusion criteria: Participants who have any of the following conditions are exclusion in this study: 1)History of poor ovarian response or severe/critical ovarian hyperstimulation syndrome (OHSS) during previous controlled ovarian stimulation cycles for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). 2)Known allergy to FSH, hCG, progesterone, or gonadotropin-releasing hormone (GnRH) analogs, or individuals with a known allergic constitution. 3)As determined by the investigator, presence of uterine abnormalities that may affect the results of the study, such as submucosal uterine fibroids >4cm or those =4cm but affecting the uterine cavity morphology, intramural uterine fibroids, pelvic or abdominal benign tumors >4cm, untreated endometrial polyps, uterine adhesions, uterine malformation, and American Society for Reproductive Medicine (ASRM) stage III-IV endometriosis, as well as abnormalities in the uterine appendages, including polycystic ovaries, ovarian cysts >3.5cm, and inability to retrieve eggs from both ovaries or one ovary, and these abnormalities have clinical significance. Additionally, patients with pituitary tumors, malignant tumors in various tissues and organs, or a history of recurrent miscarriage (defined as at least two consecutive spontaneous miscarriages occurring after confirmation of pregnancy by ultrasound and before 24 weeks of gestation) are excluded from the study. 4)Patients assessed by the investigator to have clinically significant tubal hydrosalpinx (evaluated based on previous hysterosalpingography, ultrasound tubal patency testing, or laparoscopy, showing tubal hydrosalpinx that affects oocyte retrieval or embryo transfer) are excluded from the study. 5)Presence of clinically significant abnormal cervical examination results (cervical cytology, human papillomavirus [HPV]) within the 3 months prior to screening. 6)Either partner of the couple undergoing preimplantation genetic screening/diagnosis (PGS/PGD). 7)Positive hepatitis C virus antibodies, positive human immunodeficiency virus antibodies, positive syphilis-specific antibodies, or positive hepatitis B surface antigen with hepatitis B virus DNA > upper limit of normal (ULN). 8)Known history or current diagnosis of venous thrombosis or thromboembolism, including venous thromboembolism (such as deep vein thrombosis and portal vein thrombosis), and active or recent arterial thromboembolism (such as stroke and myocardial infarction) within the past 1 year prior to screening. 9)Any known endocrine or metabolic abnormalities or systemic diseases (e.g., pituitary, adrenal, pancreatic, hepatic, or renal disorders) that would interfere with the participant's involvement in the study, except for controllable thyroid dysfunction. 10)Having undergone 3 or more controlled ovarian stimulation cycles for IVF/ICSI without achieving clinical pregnancy prior to screening. 11)Previous IVF or ART failures due to sperm/fertilization issues, with no improvement in the relevant medical conditions. 12)Any previous pregnancies within the 3 months prior to screening. 13)Use of any gonadotropin preparations or ovulation-inducing drugs (such as FSH, LH, hCG, clomiphene citrate) within the 1 month prior to screening. 14)Receipt of systemic hormone therapy within the 1 month prior to screening, except for thyroid hormone replacement therapy. 15)Vaccination within the 2 weeks prior to screening or planned receipt of any live vaccines during the study period. 16)Participati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the number of oocytes retrieved in two groups. Note: Follicles with a diameter =10 mm must be punctured. Total oocyte count: Defined as the average number of oocytes obtained per subject 36±2 hours after trigger administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total dosage of experimental drug;Duration of experimental drug stimulation in the trial (number of days);Hormone levels (LH, E2, P) and their changes after experimental drug administration in the trial.;Serum E2 level on the trigger day;The levels and changes of hormones [luteinizing hormone (LH), estradiol (E2), progesterone (P) measured in the central laboratory] after administration of experimental drugs;The percentage of follicles with a diameter =10mm on the 6th day of ovarian stimulation (number of follicles with a diameter =10mm divided by the total number of follicles).;The percentage of follicles with a diameter =14mm on trigger day (number of follicles with a diameter =14mm divided by the total number of follicles).;The proportion of MII (metaphase II) oocytes to the total number of oocytes retrieved on the day of egg retrieval, specifically for intracytoplasmic sperm injection (ICSI) only.;The normal fertilization rate refers to the percentage of embryos showing both pronuclei (PN) and polar bodies (PB) after in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).;The usable embryo rate on the 3rd day after egg retrieval ;The embryo transfer rate (on the 3rd to 5th day after egg retrieval);The serum hCG/ß-hCG positive rate (12-14 days after embryo transfer);The clinical pregnancy rate (4-7 weeks after embryo transfer) ; | — |
Countries
China
Contacts
Public ContactCao Yunxia; Qiao Jie
The first affiliated hospital of Anhui medical university/Peking university third hospita
Outcome results
None listed