Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality
- Registration Number
- NCT03966339
- Lead Sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 128
- 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.
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- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GH group Growth hormone Growth Hormone adding to controlled ovarian hyperstimulation
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method number of high-quality oocytes four months number of oocytes with diameter ≥18mm at triggering day
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
total amount of Gn used four months total amount of Gn used
implantation rate 28 days after embryo transplanted proportion of implanted embryos in transplanted embryos
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)
Trial Locations
- Locations (1)
Reproductive & Genetic Hospital of CITIC-XIANGYA
🇨🇳Changsha, Hunan, China