- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03966339
Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality
Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality:a Randomized Controlled Study
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yi Tang, Doctor
- Phone Number: 0731-82355100
- Email: cstangyi@sina.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China
- Recruiting
- Reproductive & Genetic Hospital of CITIC-Xiangya
-
Contact:
- yi tang, doctor
- Phone Number: 0731-82355100
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GH group
Growth Hormone adding to controlled ovarian hyperstimulation
|
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.
Other Names:
|
No Intervention: control group
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
Time Frame: the third day after oocyte retrieval
|
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
Time Frame: the third day after oocyte retrieval
|
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
Time Frame: 28 days after embryo transplanted
|
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
Time Frame: four months
|
number of oocytes with diameter ≥18mm at triggering day
|
four months
|
implantation rate
Time Frame: 28 days after embryo transplanted
|
proportion of implanted embryos in transplanted embryos
|
28 days after embryo transplanted
|
total amount of Gn used
Time Frame: four months
|
total amount of Gn used
|
four months
|
total days of Gn used
Time Frame: two months
|
total days of Gn used
|
two months
|
E2 levels at triggering day
Time Frame: four months
|
E2 levels at triggering day
|
four months
|
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)
|
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
Time Frame: 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
Time Frame: four months
|
IGF-I level at triggering day
|
four months
|
number of blastocysts at the fifth,sixth or seventh day after oocyte retrieval
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Study Director: Fei Gong, Doctor, Reproductive & Genetic Hospital of CITIC-Xiangya
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2019004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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