Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality

• Growth hormone (Drug), also known as Experimental group: 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.

Primary outcomes

• 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 outcomes

• 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
• number of high-quality oocytes [four months]: number of oocytes with diameter ≥18mm at triggering day
• 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
• 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)
• 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

Sex: Female, ages: 20 Years to 39 Years

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.

• Results publication: Tang Y, Li X, Hu C, Guan R, Wang Z, Zhang S, Tao G, Qu J, Gong F. Exploring the potential benefits of growth hormone co-treatment on embryo quality in IVF: a randomized controlled open-label trial. Reprod Biol Endocrinol. 2025 Mar 15;23(1):42. doi: 10.1186/s12958-025-01374-3. PMID 40089744

• Fei Gong, Doctor, Study director, Reproductive & Genetic Hospital of CITIC-Xiangya