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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Reproductive & Genetic Hospital of CITIC-Xiangya
        • Contact:
          • yi tang, doctor
          • Phone Number: 0731-82355100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Experimental group
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Fei Gong, Doctor, Reproductive & Genetic Hospital of CITIC-Xiangya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

May 14, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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