Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality

Infertility,Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966339
• Other study ID #: P2019004
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: Yi Tang, Doctor
• Phone: 0731-82355100
• Email: cstangyi[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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-? 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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Infertility,Female

Intervention

Drug:
• Growth 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.

Locations

Country	Name	City	State
China	Reproductive & Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	number of high-quality oocytes	number of oocytes with diameter =18mm at triggering day	four months
Secondary	implantation rate	proportion of implanted embryos in transplanted embryos	28 days after embryo transplanted
Secondary	total amount of Gn used	total amount of Gn used	four months
Secondary	total days of Gn used	total days of Gn used	two months
Secondary	E2 levels at triggering day	E2 levels at triggering day	four months
Secondary	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)
Secondary	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
Secondary	IGF-I level at triggering day	IGF-I level at triggering day	four months
Secondary	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