Clinical trial NCT03966339: Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality
Official title: Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality：a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility,Female
Keywords: Infertility,Female
Embryo Development
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 128
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: number of high-quality embryos at D3
timeFrame: the third day after oocyte retrieval
measure: proportion of high-quality embryos at D3
timeFrame: the third day after oocyte retrieval
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 28 days after embryo transplanted
measure: number of high-quality oocytes
timeFrame: four months
measure: implantation rate
timeFrame: 28 days after embryo transplanted
measure: total amount of Gn used
timeFrame: four months
measure: total days of Gn used
timeFrame: two months
measure: E2 levels at triggering day
timeFrame: four months
measure: IGF-I level at the first day of injecting GH and befor injecting GH(GH group)
timeFrame: at the first day of injecting GH and befor injecting GH(GH group)
measure: IGF-I level at the first day of injecting Gn and before injecting Gn
timeFrame: at the first day of injecting Gn and before injecting Gn
measure: IGF-I level at triggering day
timeFrame: four months
measure: number of blastocysts at the fifth,sixth or seventh day after oocyte retrieval
timeFrame: at the fifth,sixth or seventh day after oocyte retrieval
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
Study officials:
affiliation: Reproductive & Genetic Hospital of CITIC-Xiangya
name: Fei Gong, Doctor
role: STUDY_DIRECTOR
References: