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Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality

R

Reproductive & Genetic Hospital of CITIC-Xiangya

Status

Unknown

Conditions

Infertility,Female

Treatments

Drug: Growth hormone

Study type

Interventional

Funder types

Other

Identifiers

NCT03966339
P2019004

Details and patient eligibility

About

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.

Enrollment

128 estimated patients

Sex

Female

Ages

20 to 39 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

128 participants in 2 patient groups

GH group
Experimental group
Description:
Growth Hormone adding to controlled ovarian hyperstimulation
Treatment:
Drug: Growth hormone
control group
No Intervention group
Description:
regular controlled ovarian hyperstimulation

Trial contacts and locations

1

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Central trial contact

Yi Tang, Doctor

Data sourced from clinicaltrials.gov

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