Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality

NCT03966339 | Unknown

• 1 other identifier: P2019004
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility,Female

Keywords

Infertility,Female; Embryo Development

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• clinical pregnancy rate

  28 days after embryo transplanted

• number of high-quality oocytes

  four months

• implantation rate

  28 days after embryo transplanted

• total amount of Gn used

  four months

• total days of Gn used

  two months

Study Arms (2)

GH group

EXPERIMENTAL

Growth Hormone adding to controlled ovarian hyperstimulation

Drug: Growth hormone

control group

NO INTERVENTION

regular controlled ovarian hyperstimulation

Interventions

Growth hormone DRUG

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.

Also known as: Experimental group

GH group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• )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.

You may not qualify if:

• \- 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.
• )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.

Sponsors & Collaborators

• Reproductive & Genetic Hospital of CITIC-Xiangya: lead

Study Sites (1)

Reproductive & Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Fei Gong, Doctor

  Reproductive & Genetic Hospital of CITIC-Xiangya

  STUDY DIRECTOR

Central Study Contacts

Yi Tang, Doctor

CONTACT

0731-82355100; cstangyi@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 29, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

CN (1)