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Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality

Primary Purpose

Infertility,Female

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Growth hormone
Sponsored by
Reproductive & Genetic Hospital of CITIC-Xiangya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility,Female focused on measuring Infertility,Female, Embryo Development

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Reproductive & Genetic Hospital of CITIC-XIANGYARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GH group

control group

Arm Description

Growth Hormone adding to controlled ovarian hyperstimulation

regular controlled ovarian hyperstimulation

Outcomes

Primary Outcome Measures

number of high-quality embryos at D3
number of embryos grading 6C-II and above 6C-II at 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

Secondary Outcome Measures

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
number of high-quality oocytes
number of oocytes with diameter ≥18mm at triggering day
implantation rate
proportion of implanted embryos in transplanted embryos
total amount of Gn used
total amount of Gn used
total days of Gn used
total days of Gn used
E2 levels at triggering day
E2 levels at triggering day
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)
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
IGF-I level at triggering day
IGF-I level at triggering day
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

Full Information

First Posted
May 14, 2019
Last Updated
January 10, 2022
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
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1. Study Identification

Unique Protocol Identification Number
NCT03966339
Brief Title
Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality
Official Title
Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality:a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility,Female
Keywords
Infertility,Female, Embryo Development

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GH group
Arm Type
Experimental
Arm Description
Growth Hormone adding to controlled ovarian hyperstimulation
Arm Title
control group
Arm Type
No Intervention
Arm Description
regular controlled ovarian hyperstimulation
Intervention Type
Drug
Intervention Name(s)
Growth hormone
Other Intervention Name(s)
Experimental group
Intervention Description
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 Outcome Measure Information:
Title
number of high-quality embryos at D3
Description
number of embryos grading 6C-II and above 6C-II at the third day after oocyte retrieval
Time Frame
the third day after oocyte retrieval
Title
proportion of high-quality embryos at D3
Description
proportion of embryos grading 6C-II and above 6C-II at the third day after oocyte retrieval
Time Frame
the third day after oocyte retrieval
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Description
proportion of patients with presence of a gestational sac with fetal heartbeat by transvaginal ultrasound at 28 days after ET in transplanted patients
Time Frame
28 days after embryo transplanted
Title
number of high-quality oocytes
Description
number of oocytes with diameter ≥18mm at triggering day
Time Frame
four months
Title
implantation rate
Description
proportion of implanted embryos in transplanted embryos
Time Frame
28 days after embryo transplanted
Title
total amount of Gn used
Description
total amount of Gn used
Time Frame
four months
Title
total days of Gn used
Description
total days of Gn used
Time Frame
two months
Title
E2 levels at triggering day
Description
E2 levels at triggering day
Time Frame
four months
Title
IGF-I level at the first day of injecting GH and befor injecting GH(GH group)
Description
IGF-I level at the first day of injecting GH and befor injecting GH(GH group)
Time Frame
at the first day of injecting GH and befor injecting GH(GH group)
Title
IGF-I level at the first day of injecting Gn and before injecting Gn
Description
IGF-I level at the first day of injecting Gn and before injecting Gn
Time Frame
at the first day of injecting Gn and before injecting Gn
Title
IGF-I level at triggering day
Description
IGF-I level at triggering day
Time Frame
four months
Title
number of blastocysts at the fifth,sixth or seventh day after oocyte retrieval
Description
number of blastocysts formation after culturing at the fifth,sixth or seventh day after oocyte retrieval
Time Frame
at the fifth,sixth or seventh day after oocyte retrieval

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Tang, Doctor
Phone
0731-82355100
Email
cstangyi@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Gong, Doctor
Organizational Affiliation
Reproductive & Genetic Hospital of CITIC-Xiangya
Official's Role
Study Director
Facility Information:
Facility Name
Reproductive & Genetic Hospital of CITIC-XIANGYA
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yi tang, doctor
Phone
0731-82355100

12. IPD Sharing Statement

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Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality

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