Infertility,FemaleNCT03966339
Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality
A study testing Growth hormone in people with Infertility,Female, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Infertility,Female
- What is being tested?
- Growth hormone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan
yi tang, doctor, 0731-82355100
About this study
Official title: 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.
- Conditions
- Infertility,Female
- Being tested
- Growth hormone
- Keywords
- Infertility,Female, Embryo Development
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormoneDrug
Also called Experimental group
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.
| Study group | Role | What they receive |
|---|---|---|
| GH group | Experimental | Growth Hormone adding to controlled ovarian hyperstimulation Receives: Drug: Growth hormone |
| control group | No intervention | regular controlled ovarian hyperstimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of high-quality embryos at D3
number of embryos grading 6C-II and above 6C-II at the third day after oocyte retrieval
Measured: 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
Measured: the third day after oocyte retrieval
Secondary outcomes (10)
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
Measured: 28 days after embryo transplanted
number of high-quality oocytes
number of oocytes with diameter ≥18mm at triggering day
Measured: four months
implantation rate
proportion of implanted embryos in transplanted embryos
Measured: 28 days after embryo transplanted
total amount of Gn used
total amount of Gn used
Measured: four months
total days of Gn used
total days of Gn used
Measured: two months
E2 levels at triggering day
E2 levels at triggering day
Measured: four months
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)
Measured: 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
Measured: at the first day of injecting Gn and before injecting Gn
IGF-I level at triggering day
IGF-I level at triggering day
Measured: four months
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
Measured: at the fifth,sixth or seventh day after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility,FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Gong, Doctor, Study director, Reproductive & Genetic Hospital of CITIC-Xiangya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966339
- Sponsor's protocol ID
- P2019004
- Status last verified
- Jan 2022
- First submitted
- 14 May 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40089744
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality：a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03966339
- Acronym / sponsor ID
- P2019004
- Conditions
- Infertility,Female
- Keywords
- Infertility,Female, Embryo Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH group | Experimental | Drug: Growth hormoneGrowth Hormone adding to controlled ovarian hyperstimulation |
| control group | No intervention | –regular controlled ovarian hyperstimulation |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth hormoneAlso: Experimental groupGH 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. | Drug | GH group |
Primary outcome
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
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
10 secondary outcomes
clinical pregnancy rate
Time frame: 28 days after embryo transplanted
number of high-quality oocytes
Time frame: four months
implantation rate
Time frame: 28 days after embryo transplanted
total amount of Gn used
Time frame: four months
total days of Gn used
Time frame: two months
E2 levels at triggering day
Time frame: 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 Gn and before injecting Gn
Time frame: at the first day of injecting Gn and before injecting Gn
IGF-I level at triggering day
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 40089744Tang 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.
Related trials for Infertility,Female
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Gong, Doctor study director
Reproductive & Genetic Hospital of CITIC-Xiangya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth hormone in people with Infertility,Female, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Tang, Doctor (0731-82355100, cstangyi@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of high-quality embryos at D3 (time frame: the third day after oocyte retrieval). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03966339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.