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Status unknownNCT03966339Updated Jan 11, 2022

Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality

An interventional study of Growth hormone in Infertility,Female, sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya. Status unknown at 1 site in China. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
20 Years to 39 Years
Sex
Female
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Study 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.

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Conditions studied

  • Infertility,Female

Keywords

  • Infertility,Female
  • Embryo Development
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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 128 is close to the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Reproductive & Genetic Hospital of CITIC-Xiangya is the lead sponsor of 26 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    GH group

    Growth Hormone adding to controlled ovarian hyperstimulation

    Drug: Growth hormone

  • No intervention
    control group

    regular controlled ovarian hyperstimulation

Interventions

  • DrugGrowth hormone

    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

06

What researchers measure

Primary outcomes

  1. number of high-quality embryos at D3

    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

  2. proportion of high-quality embryos at D3

    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 outcomes

  1. 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

    Time frame: 28 days after embryo transplanted

  2. number of high-quality oocytes

    number of oocytes with diameter ≥18mm at triggering day

    Time frame: four months

  3. implantation rate

    proportion of implanted embryos in transplanted embryos

    Time frame: 28 days after embryo transplanted

  4. total amount of Gn used

    total amount of Gn used

    Time frame: four months

  5. total days of Gn used

    total days of Gn used

    Time frame: two months

  6. E2 levels at triggering day

    E2 levels at triggering day

    Time frame: four months

  7. 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)

    Time frame: at the first day of injecting GH and befor injecting GH(GH group)

  8. 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

    Time frame: at the first day of injecting Gn and before injecting Gn

  9. IGF-I level at triggering day

    IGF-I level at triggering day

    Time frame: four months

  10. 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

    Time frame: at the fifth,sixth or seventh day after oocyte retrieval

07

Study locations

1 of 1 sites recruiting
  • Reproductive & Genetic Hospital of CITIC-XIANGYA
    Changsha, Hunan, China
    • yi tang, doctor · Contact · 0731-82355100
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03966339
Lead sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Responsible party
Sponsor
First posted
May 29, 2019
Start date
Aug 1, 2019
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jan 11, 2022

Study contacts

Yi Tang, Doctor
Contact
cstangyi@sina.com
0731-82355100
Fei Gong, Doctor
study director · Reproductive & Genetic Hospital of CITIC-Xiangya

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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