Infertility
Conditions
Interventions
Test group:Biorocks Automatic Vitrification System
Control group:Cryotop Vessel and Vitrification Media Kit from Kitazato
Sponsors
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
Female
Age
20 Years to 39 Years
Inclusion criteria
Inclusion criteria: 1. Female aged between 20 and 39 years (inclusive of 20 and 39 years). 2. Female with a Body Mass Index (BMI) between 18 and 30 kg/m². 3. Both partners meet the criteria for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI). 4. On Day 5 or Day 6 of blastocyst culture (D5 or D6), vitrification will be performed on high-quality blastocysts graded 3 or higher, with no Grade C in the inner cell mass or trophectoderm scores, according to Gardner's blastocyst evaluation criteria. 5. Both partners are willing to accept single blastocyst transfer following the thawing of a single vitrified blastocyst in a frozen-thawed cycle. 6. Both partners are willing to participate in this clinical trial, comply with the trial protocol, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Women with previous embryo transfer failures (>=3) without achieving clinical pregnancy. 2. Women with a history of recurrent miscarriage (defined as two or more consecutive pregnancy losses before 28 weeks, including biochemical pregnancy). 3. Women with confirmed uterine abnormalities, such as uterine malformations (e.g., septate uterus, unicornuate uterus, bicornuate uterus), intrauterine adhesions, scarred uterus, endometrial abnormalities (e.g., polyps, adhesions), or unexplained abnormal uterine bleeding. 4. Women with other gynecological diseases, such as unexplained vaginal bleeding, ovarian cysts >30 mm in diameter, intramural fibroids >30 mm in diameter, or abnormal cervical cytology within one year prior to enrollment. 5. Women with malignant tumors in other organs or tissues. 6. Women allergic to or intolerant of ovarian stimulation drugs or sex hormones. 7. Other than the indications for IVF-ET or ICSI, female patients who have other diseases that may affect hormone levels, such as uncontrolled thyroid disorders or pituitary diseases. 8. Women with a history of pregnancy complications, such as gestational hypertension, preeclampsia, or gestational diabetes. 9. Women with diseases that may impact pregnancy, including but not limited to severe liver or kidney dysfunction, severe cardiovascular diseases (e.g., uncontrolled hypertension, unstable angina, myocardial infarction), severe cerebrovascular diseases (e.g., cerebral aneurysm, stroke), uncontrolled diabetes, undergoing radiotherapy or chemotherapy, or a personal or family history of thrombosis. 10. Women who are already pregnant or breastfeeding. 11. Either partner has a positive serology for HIV, hepatitis C virus antibodies (HCV-Ab), or confirmed positive syphilis antibody tests. 12. Either partner has severe mental illness or acute sexually transmitted infections of the urogenital system. 13. Either partner has genetic conditions deemed unsuitable for reproduction under the Maternal and Infant Health Care Law, or conditions preventing preimplantation genetic diagnosis (PGD). 14. Either partner has serious adverse habits, such as substance abuse. 15. Either partner has been exposed to teratogenic levels of radiation, toxins, or drugs and is still within the exposure period. 16. Either partner has participated in another clinical trial involving drugs or medical devices within three months prior to this study. 17. Any medical condition deemed by the investigator to pose a risk to the patient or affect the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blastocyst survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blastocyst implantation rate;Clinical pregnancy rate;Ongoing pregnancy rate ;Early miscarriage rate;Performance of the device; | — |
Countries
China
Contacts
Public ContactHaixiang Sun
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed