Infertility,Female
Conditions
Keywords
Infertility,Female, Embryo Development
Brief summary
GH plays an important role in the synthesis of ovarian steroid hormone and follicular development as a paracrine hormone.GH can regulate the growth hormone receptor and strengthen the function of mitochondria to improve the quality of the female oocyte.In this study, a prospective randomized control was used to explore the effect of GH adjuvant therapy on embryo quality.
Interventions
DRUGGrowth hormone
GH has been considered as a cogonadotropin, which plays an important role in the synthesis of ovarian steroid hormone and follicular development as a paracrine hormone.GH can regulate the growth hormone receptor and strengthen the function of mitochondria to improve the quality of the female oocyte.
Sponsors
Reproductive & Genetic Hospital of CITIC-Xiangya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* 1)infertility women whose age ≥20 and ≤39 years old; 2)women has done IVF/ICSI assisted treatment ≥1 times； 3)number of IVF/ICSI assisted treatment cylces with ≥6 oocytes retrieved ≥1； 4)number of IVF/ICSI assisted treatment cylces with ≥50% fertilization rate ≥1 ; 5)historical assisted reproduction cycles without ≥6C-Ⅱ level embryos at the third day after oocytes retrieval or without blastocyst formation after blastocyst culturing.
Exclusion criteria
\- 1) Diseases related to IVF treatment outcome, such as untreated hydrosalpinx, uterine fibroids affecting uterine cavity, myometriosis, endometrial lesions, obvious uterine abnormalities,etc; 2)Severe acute or chronic liver or kidney diseases, such as cirrhosis, acute or chronic renal failure, hepatitis B virus activity period,etc.;in patients with abnormal liver and kidney function, the AST or ALT detection value was 2.5 times higher than the upper limit of normal, and the serum creatinine was 2 times higher than the upper limit of normal. 3)Endocrine and metabolic diseases and adrenal diseases, such as diabetes, Cushing's syndrome,etc.; 4)People has allergy history of growth hormone product; 5)Participating in other clinical research; 6)Other conditions that researchers determined not fit to be enrolled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of high-quality embryos at D3 | the third day after oocyte retrieval | number of embryos grading 6C-II and above 6C-II at the third day after oocyte retrieval |
| proportion of high-quality embryos at D3 | the third day after oocyte retrieval | proportion of embryos grading 6C-II and above 6C-II at the third day after oocyte retrieval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| implantation rate | 28 days after embryo transplanted | proportion of implanted embryos in transplanted embryos |
| total amount of Gn used | four months | total amount of Gn used |
| total days of Gn used | two months | total days of Gn used |
| E2 levels at triggering day | four months | E2 levels at triggering day |
| clinical pregnancy rate | 28 days after embryo transplanted | proportion of patients with presence of a gestational sac with fetal heartbeat by transvaginal ultrasound at 28 days after ET in transplanted patients |
| IGF-I level at the first day of injecting Gn and before injecting Gn | at the first day of injecting Gn and before injecting Gn | IGF-I level at the first day of injecting Gn and before injecting Gn |
| IGF-I level at triggering day | four months | IGF-I level at triggering day |
| number of blastocysts at the fifth,sixth or seventh day after oocyte retrieval | at the fifth,sixth or seventh day after oocyte retrieval | number of blastocysts formation after culturing at the fifth,sixth or seventh day after oocyte retrieval |
| IGF-I level at the first day of injecting GH and befor injecting GH(GH group) | at the first day of injecting GH and befor injecting GH(GH group) | IGF-I level at the first day of injecting GH and befor injecting GH(GH group) |
| number of high-quality oocytes | four months | number of oocytes with diameter ≥18mm at triggering day |
Countries
China
Contacts
Primary ContactYi Tang, Doctor
Outcome results
None listed