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Comparison of domestic rFSH and uFSH in COS follicular growth and development and clinical outcome at fixed starting dose: a prospective randomized clinical study

Comparison of domestic rFSH and uFSH in COS follicular growth, development and clinical outcomes at a fixed priming dose: a prospective randomized clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063529
Enrollment
Unknown
Registered
2022-09-10
Start date
2022-09-09
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertile patients

Interventions

Experimental group:Domestic rFSH
control group:Domestic uFSH

Sponsors

The First Affiliated Hospital of USTC(Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 39 Years

Inclusion criteria

Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study: 1. Age 20<=y<40 years old, married women; 2. 1.1mg/L<AMH, basal FSH<=10 IU/ml, normal range of other endocrine functions (such as androgens, prolactin, thyrotropin, etc.); 3. 7<AFC; 4. Body mass index (BMI) 18.5kg/m^2<=BMI<25kg/m^2; 5. Suitable for patients with ART-controlled superovulation, the first IVF/intracytoplasmic sperm injection (ICSI) cycle; 6. Physiological menstrual cycle (25-35 day cycle); 7. Transvaginal ultrasonography, no pathological findings; 8. Not taking ovulation-stimulating drugs such as clomiphene citrate or gonadotropin one month before the start of the study; 9. Those who participated voluntarily and signed the informed consent.

Exclusion criteria

Exclusion criteria: Any of the following can be excluded: 1. Infertile patients with polycystic ovary syndrome (PCOS)/female chromosomal abnormalities; untreated infertile patients with positive autoimmune antibodies; 2. Gynecological related diseases: scarred uterus, reproductive tract malformations (such as unicornuate uterus/infant uterus/double cervix, etc.), abnormal uterine bleeding, untreated hydrosalpinx/uterine polyps/uterine infection and intrauterine adhesions, ? ~ Stage IV endometriosis/ovarian cyst/uterine fibroids/benign tumors in the pelvis and abdominal cavity >4cm in diameter or malignant tumors, etc.; 3. Endocrine and metabolic diseases (such as hyperprolactinemia/hyperandrogenemia/hypothyroidism, etc.), heart and brain-related diseases (such as hypertension/cerebral infarction/congenital heart disease, etc.), sexually transmitted diseases (such as syphilis/ AIDS, etc.); 4. Severe liver and kidney function damage, that is, blood alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are 2.5 times higher than the upper limit of normal, serum creatinine (Cr) and blood urea nitrogen (BUN) 2 times higher than the upper limit of normal; 5. Patients seeking preimplantation genetic testing (PGT) treatment; 6. Participate in another clinical study at the same time; 7. History of allergy to ovulation induction related drugs; 8. Patients with positive serum pregnancy test; 9. The researcher believes that it is not suitable to be selected for this researcher.

Design outcomes

Primary

MeasureTime frame
the Number of Retrieved Oocytes;

Secondary

MeasureTime frame
Average growth rate of mature follicles;Adjust the number of dose cycles;Clinical pregnancy rate of fresh embryo transfer;the estradiol levels at the day of Human chorionic gonadotrophins administration;follicle-stimulating hormone; leuteinizing hormone;Endometrial thickness and follicle distribution;Fertilization rate;Good-Quality embryo;Number of high-quality embryos;Implantation rate;Biochemical pregnancy rate;days of gonadotropin ;Total dose of gonadotropin;total patient cost;time to pregnancy;

Countries

China

Contacts

Public ContactHu Meihong

The First Affiliated Hospital of USTC(Anhui Provincial Hospital)

guyueliny@126.com+86 15955159204

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026