InfertilityNCT05585177
Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve
A study testing Growth hormone in people with Infertility, run by Nanjing University at 1 site in China.
Trial summary
This study was a prospective randomized controlled trial. Patients aged <35 years with decreased clinical reserve function (AFC<5, Follicle stimulating hormone > 10miu/ml, Anti-mullerian hormone < 1.1μg/L) and receiving IVF/ICSI assisted ovulation induction in our hospital were included in this study. Read more about this study
- Who is it for?
- Ages 20 to 34 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Growth hormone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 30 Oct 2025
- 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 34 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age < 35 years;
- AFC≤5
- Follicle stimulating hormone > 10miu/ml;
- Anti-mullerian hormone < 1.1μg/L
- (2 out of 2-4 items can be met)
Who cannot join
- Severe male factors: spermatozoa collected by testicular sperm aspiration (TESA) or percutaneous epididymal sperm aspiration (PESA) was used for intracytoplasmic sperm injection (ICSI) cycle of single spermatozoa;
- Patients with severe adenomyosis, endometriosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
- Diabetes mellitus, insulin resistance;
- chromosomal karyotype abnormality in either spouse;
- Any pregnancy or contraindications of assisted reproductive technology;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Haixiang Sun, 025-83107188, stevensunz@163.com
About this study
Official title: A Randomized Controlled Trial of Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve
This study was a prospective randomized controlled trial. Patients aged <35 years with decreased clinical reserve function (AFC<5, Follicle stimulating hormone > 10miu/ml, Anti-mullerian hormone < 1.1μg/L) and receiving IVF/ICSI assisted ovulation induction in our hospital were included in this study. After randomization using Excel(Microsoft Corporation, Albuquerque, USA), these patients were divided into two groups. Group A was the experimental group, which was treated with growth hormone for 3 months (2 units per day) before IVF/ICSI. Group B was the control group, which was directly assisted by IVF/ICSI.
- Conditions
- Infertility
- Being tested
- Growth hormone
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormoneDrug
Also called IVF/ICSI
3 months of growth hormone treatment (2 units daily)
| Study group | Role | What they receive |
|---|---|---|
| Growth hormone pretreatment+IVF/ICSI | Experimental | After 3 months of Growth hormone treatment (2 units daily), IVF/ICSI was performed Receives: Drug: Growth hormone |
| IVF/ICSI | No intervention | IVF/ICSI was performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of embryos
When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of embryos formed after three days of combined sperm and egg culture in vitro was recorded.
Measured: 4 months
Secondary outcomes (2)
The number of oocytes retrieved
When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of oocytes retrieved was recorded.
Measured: 4 months
Clinical pregnancy rate
Clinical pregnancy was defined as diagnosed by increasing serum concentration of beta-Human chorionic gonadotropin 14 days after embryo transfer, and the subsequent demonstration of an intrauterine gestational sac by ultrasonography on 30 days after embryo transfer
Measured: 5-8months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-jun Ding, Nanjing University
- Investigators
- Haixiang Sun, PHD, Study director, The affiliated Drum Towel Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585177
- Sponsor's protocol ID
- SZ-2022-GH
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve
- ClinicalTrials.gov ID
- NCT05585177
- Acronym / sponsor ID
- SZ-2022-GH
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanjing UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 18 Oct 2022 (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.
This study was a prospective randomized controlled trial. Patients aged <35 years with decreased clinical reserve function (AFC<5, Follicle stimulating hormone > 10miu/ml, Anti-mullerian hormone < 1.1μg/L) and receiving IVF/ICSI assisted ovulation induction in our hospital were included in this study. After randomization using Excel(Microsoft Corporation, Albuquerque, USA), these patients were divided into two groups. Group A was the experimental group, which was treated with growth hormone for 3 months (2 units per day) before IVF/ICSI. Group B was the control group, which was directly assisted by IVF/ICSI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth hormone pretreatment+IVF/ICSI | Experimental | Drug: Growth hormoneAfter 3 months of Growth hormone treatment (2 units daily), IVF/ICSI was performed |
| IVF/ICSI | No intervention | –IVF/ICSI was performed |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age < 35 years;
- AFC≤5
- Follicle stimulating hormone > 10miu/ml;
- Anti-mullerian hormone < 1.1μg/L
- (2 out of 2-4 items can be met)
Key exclusion criteria (5 listed)
- Severe male factors: spermatozoa collected by testicular sperm aspiration (TESA) or percutaneous epididymal sperm aspiration (PESA) was used for intracytoplasmic sperm injection (ICSI) cycle of single spermatozoa;
- Patients with severe adenomyosis, endometriosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
- Diabetes mellitus, insulin resistance;
- chromosomal karyotype abnormality in either spouse;
- Any pregnancy or contraindications of assisted reproductive technology;
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: IVF/ICSI3 months of growth hormone treatment (2 units daily) | Drug | Growth hormone pretreatment+IVF/ICSI |
Primary outcome
Number of embryos
Time frame: 4 months
When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of embryos formed after three days of combined sperm and egg culture in vitro was recorded.
2 secondary outcomes
The number of oocytes retrieved
Time frame: 4 months
Clinical pregnancy rate
Time frame: 5-8months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
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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.
Haixiang Sun, PHD study director
The affiliated Drum Towel Hospital of Nanjing University Medical School
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, run by Nanjing University 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 5 inclusion and 5 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 24 Oct 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 Qingqing Shi, PHD (025-83106666, qqshnju@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of embryos (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2022.