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Study on the effectiveness and safety of assisted reproductive medium such as fertilization medium and 1-step culture medium used in the in vitro fertilization-embryo transfer (IVF-ET)

Study on the effectiveness and safety of assisted reproductive medium such as fertilization medium and 1-step culture medium used in the in vitro fertilization-embryo transfer (IVF-ET)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054559
Enrollment
Unknown
Registered
2021-12-19
Start date
2022-01-17
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

Infertility

Interventions

Experimental group:Fertilization Medium, One Step Culture Medium
Control group:Fertilization Medium, Cleavage Culture Medium, Blastocyst Culture Medium

Sponsors

First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. When signing the informed consent, female subjects aged 20 to 35 years; 2. Infertile women are diagnosed with tubal infertility, unexplained infertility, grade I/II endometriosis (defined according to the ASRM classification standard revised in 1996), and plan to undergo in vitro fertilization-embryo transfer (IVF-ET). ) technicians; 3. Female subjects with a BMI of 17 kg/m2<=BMI<=30 kg/m2; 4. Both spouses use autologous germ cells for assisted reproduction; 5. Both spouses can fully understand the purpose of screening, show sufficient compliance with the research protocol, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Known past or current thromboembolic disease, such as venous thrombosis (deep vein thrombosis, portal vein thrombosis, etc.), arterial thrombosis (such as stroke and myocardial infarction, etc.); 2. According to the judgment of the investigator, the female subjects have major systemic diseases, major endocrine or metabolic abnormalities that are not suitable for participating in this study; 3. Past or current history of malignant tumors such as ovary, breast, uterus, pituitary or hypothalamus; 4. Known history of chemotherapy or radiotherapy; 5. Either one of the couple has a history of drug abuse, drug abuse, or a history of alcohol abuse within 30 days before screening (consumption of more than 14 units of alcohol per week) and other bad habits; 6. Either one of the couple is exposed to teratogenic radiation, poisons, and medicines and is in the active period; 7. Those who have experienced ectopic pregnancy or any pregnancy within 3 months before enrollment; 8. Female subjects are pregnant, breastfeeding or have contraindications to pregnancy at the time of screening; 9. Participated in clinical trials of other drugs or medical devices within 3 months before enrollment; 10. According to the investigator's judgment, there are any other circumstances that are not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Fertilization rate;Blastocyst formation rate;

Secondary

MeasureTime frame
High quality blastocyst formation rate;Clinical pregnancy rate;Ongoing pregnancy rate;

Countries

China

Contacts

Public ContactSun Yingpu

First Affiliated Hospital of Zhengzhou University

hulinli1999@16.com+86 15890619576

Outcome results

None listed

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