Infertility, Female, Intracytoplasmic Sperm Injections
Conditions
Brief summary
The goal of this clinical trial is to test Piezo-ICSI on improving oocyte fertilization and embryo development in elderly infertile patients undergoing intracytoplasmic sperm injection (ICSI). The main question it aims to answer is whether Piezo-ICSI could improve oocyte fertilization and embryo development. Participants requested ICSI are asked to randomly culture equal numbers of oocyte and embryo with or without Piezo-ICSI. At the time of injection, two or more mature oocytes were split into two groups (i) conventional ICSI and (ii) Piezo-ICSI (50:50 split).
Detailed description
After being informed about the study and potential risks, all participants will write the informed contents. This study is a randomized controlled study compare different ICSI methods on the fertilization and embryo development. Sibling oocytes were randomly divided into test group (Piezo-ICSI) and control group (conventional ICSI). Specific method of randomization: all the oocytes of each subject were distributed into two dishes (dish 1 and dish 2). If the oocyte number is odd, put the extra oocyte into dish 1. Using statistical software, the two dishes were randomly treated as test group and control group. Thus, a random allocation table was generated and a separate random envelope was made for each subject. The random envelope is kept and distributed by the relevant personnel who are not involved in the screening and treatment of subjects and are authorized by the researcher. Each selected subject must open the random envelope. The subjects were subjected to routine ovulation promotion, and then the acquired oocytes and cumulus cell complexes (COCs) were obtained and fertilized in vitro. The test group oocytes were fertilized with Piezo-ICSI, while the control oocytes were fertilized with conventional ICSI. Thus, half of the oocytes from each elderly infertile patient were treated with Piezo-ICSI.
Interventions
DEVICEPiezo-ICSI
Participants had their oocytes cohort divided, where half were injected using conventional ICSI and the other half were injected using Piezo-ICSI.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
1. 35 years ≤ age ≤ 42 years; 2. Number of IVF/ICSI cycles ≤ 2
Exclusion criteria
1. Egg donor cycle 2. Chromosome abnormality; 3. Adenomyosis, hysteromyoma, thin endometrium, endometriosis and other uterine diseases; 4. Patients with repeated implantation failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fertilization rate post intracytoplasmic sperm injection | 16-18 hours post intracytoplasmic sperm injection | The primary outcome measure was the fertilization rate 16-18 hours post intracytoplasmic sperm injection |
Countries
China
Contacts
Primary ContactHaixiang Sun, MD
Backup ContactJie D Mei, MD
Outcome results
None listed