Skip to content

"Research on the topic of Validity and Safety Verification of Assisted Reproductive Products - Clinical Trial Protocol for Embryo Culture Medium"

"Research on the topic of Validity and Safety Verification of Assisted Reproductive Products - Clinical Trial Protocol for Embryo Culture Medium"

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082141
Enrollment
Unknown
Registered
2024-03-21
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

Infertility

Interventions

Experimental group:Experimental medical device names: Semen, Cleavage Embryo Culture Medium, Blastocyst Culture Medium Model specifications: 9340, 9310, 9312 Manufacturer: Dongyun Medical Technology (
Control group:Experimental medical device names: Semen, Cleavage Embryo Culture Medium, Blastocyst Culture Medium Model specifications: 9340, 9310, 9312 Manufacturer: Dongyun Medical Technology (Shang

Sponsors

Nanjing Medical University First Affiliated Hospital (Jiangsu Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1) Age <40 years old (with <35 years old accounting for 70% and =35 years old accounting for 30%); 2) Long protocol for ovulation induction, mild protocol for ovulation induction, or current center protocol; 3) =15 dominant follicles (diameter =14mm), =12 retrieved oocytes; 4) Infertility causes: a) Female: tubal inflammation, tubal adhesions, post-tubal ligation or chemical occlusion, and tubal developmental abnormalities; b) Male: normal semen parameters. 5) Female BMI index <25; 6) Couples using autologous reproductive cells for assisted reproduction; 7) Both couples signing an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Infertility in individuals aged =40 years; 2) Pre-implantation genetic diagnosis screening before embryo transfer; 3) Decision to freeze oocytes on the day of egg retrieval; 4) Endometrial thickness <7mm (thin endometrium); 5) Presence of endometrial or uterine cavity abnormalities that affect embryo implantation; 6) History of giving birth to a fetus with genetic defects or chromosomal abnormalities or a history of adverse pregnancy outcomes in either partner; 7) History of drug abuse in either partner; 8) Known history of chemotherapy or radiation therapy; 9) Known refusal or inability to comply with clinical visits and examinations as required by the protocol for any reason.

Design outcomes

Primary

MeasureTime frame
The utilization rate of blastocysts can be maximized.;

Secondary

MeasureTime frame
High-quality blastocyst formation rate;Fertilization rate;Cleavage rate;Implantation rate;Clinical pregnancy rate;

Countries

China

Contacts

Public ContactHu Yanqiu

Nanjing Medical University First Affiliated Hospital (Jiangsu Provincial People's Hospital)

hanlele1@126.com+86 180 5106 0567

Outcome results

None listed

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