Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality

Study Overview
=================
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.

Official Title
-----------------
Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality：a Randomized Controlled Study

Conditions
-----------------
Infertility,Female

Intervention / Treatment
-----------------
* Drug: Growth hormone


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GH group<br>Growth Hormone adding to controlled ovarian hyperstimulation | Drug: Growth hormone<br>* 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.<br>* Other names: Experimental group;|
| No Intervention: control group<br>regular controlled ovarian hyperstimulation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of high-quality embryos at D3 | number of embryos grading 6C-II and above 6C-II at the third day after oocyte retrieval | the third day after oocyte retrieval | 
| proportion of high-quality embryos at D3 | proportion of embryos grading 6C-II and above 6C-II at the third day after oocyte retrieval | the third day after oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | proportion of patients with presence of a gestational sac with fetal heartbeat by transvaginal ultrasound at 28 days after ET in transplanted patients | 28 days after embryo transplanted | 
| number of high-quality oocytes | number of oocytes with diameter ≥18mm at triggering day | four months | 
| implantation rate | proportion of implanted embryos in transplanted embryos | 28 days after embryo transplanted | 
| total amount of Gn used | total amount of Gn used | four months | 
| total days of Gn used | total days of Gn used | two months | 
| E2 levels at triggering day | E2 levels at triggering day | four months | 
| 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 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 Gn and before injecting Gn | 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 triggering day | IGF-I level at triggering day | four months | 
| number of blastocysts 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 | at the fifth,sixth or seventh day after oocyte retrieval | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility,Female, Embryo Development