in Vitro Fertilization
Conditions
Keywords
Embryo Transfer
Brief summary
Embryo Transfer With Self-spent Culture Medium or new Culture Medium in Vitro Fertilization - Embryo Transfer Process, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two?
Detailed description
Although some metabolites are present in self-spent culture medium, there are some embryonic exocrine factors secreted by embryo.These factors may have a positive impact on embryo implantation and subsequent development. So it is necessary to compare the two ways of embryo transfer with Self-spent Culture Medium or New Culture Medium in vitro fertilization - embryo transfer process. The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two?
Interventions
PROCEDURESelf-spent Culture Medium
Replace embryo transfer solution with Self-spent culture medium in IVF-ET.
Sponsors
Bin Wu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Infertility female patients with tubal factors, * Infertile female patients with spouse factors
Exclusion criteria
* Intrauterine adhesions, * Endometriosis, * Primary ovarian insufficiency， * Infectious disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Pregnant After 4 Weeks | 4 weeks | Observe the clinical pregnancy rate under different embryo transfer methods |
| Live Birth | 40 weeks | Observe the live birth rate under different embryo transfer methods |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Self-spent Culture Medium Changing embryo transfer solution with self-spent culture medium
Self-spent Culture Medium: Replace embryo transfer solution with Self-spent culture medium in IVF-ET. | 150 |
| New Culture Medium embryo transfer with new culture medium in IVF-ET | 168 |
| Total | 318 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal embryo transfer operation | 10 | 7 |
Baseline characteristics
| Characteristic | Self-spent Culture Medium | New Culture Medium | Total |
|---|---|---|---|
| Age, Continuous | 30.31 years STANDARD_DEVIATION 4.08 | 29.72 years STANDARD_DEVIATION 4.77 | 29.99 years STANDARD_DEVIATION 4.11 |
| duration of infertility | 3.44 years STANDARD_DEVIATION 2.24 | 3.58 years STANDARD_DEVIATION 3.39 | 3.51 years STANDARD_DEVIATION 2.97 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment China | 150 Participants | 168 Participants | 318 Participants |
| Sex: Female, Male Female | 150 Participants | 168 Participants | 318 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 168 |
| other Total, other adverse events | 0 / 150 | 0 / 168 |
| serious Total, serious adverse events | 0 / 150 | 0 / 168 |
Outcome results
Primary
Live Birth
Observe the live birth rate under different embryo transfer methods
Time frame: 40 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-spent Culture Medium | Live Birth | 78 Participants |
| New Culture Medium | Live Birth | 74 Participants |
Primary
Number of Participants Pregnant After 4 Weeks
Observe the clinical pregnancy rate under different embryo transfer methods
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self-spent Culture Medium | Number of Participants Pregnant After 4 Weeks | 85 Participants |
| New Culture Medium | Number of Participants Pregnant After 4 Weeks | 82 Participants |