Poor Ovarian ReserveNCT04588844
Effect of Growth Hormone Injection on the IVF/ICSI Outcome of Patients With Poor Ovarian Reserve.
A study testing Polyethylene Glycol Recombinant Human Somatropin in people with Poor Ovarian Reserve, run by Shandong University.
Trial summary
Declined fertility and ovarian reserve in older women are associated with lower density of Growth hormone (GH) receptors and dysregulation in GH secretion. GH can regulate the expression of growth hormone receptor and strengthen the function of mitochondria, which could improve the quality of the female oocyte. Read more about this study
- Who is it for?
- Ages 35 to 40 years, women only
- Conditions the study is for
- Poor Ovarian Reserve
- What is being tested?
- Polyethylene Glycol Recombinant Human Somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 20 Mar 2023
- 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 35 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1)Married women between 35-40 years old; 2) serum AMH< 1.2ng/ml, and basal FSH<20IU/L during the screening period or within 6 months; 3) 18kg/m2≤BMI<30kg/m2; 4) Previous ART cycles <3.
Who cannot join
- 1）Gynecological diseases that affect pregnancy outcomes, such as submucous uterine myoma, intramural uterine myoma≥4cm, Ovarian cyst≥4cm, endometriosis, Uterine malformation, Tuberculosis of reproductive system; 2) Spontaneous abortion≥3 times; 3) Chromosomal abnormalities (except polymorphism) in one or both spouses; 4) Patients with well-defined and uncontrolled endocrine, metabolic, and adrenal diseases, such as diabetes, thyroid disease, Cushing's syndrome; 5) Patients with malignant tumors; 6) Previous use of somatropin products.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Polyethylene Glycol Recombinant Human Growth Hormone Injection on the IVF/ICSI Outcome of Patients With Poor Ovarian Reserve
Declined fertility and ovarian reserve in older women are associated with lower density of Growth hormone (GH) receptors and dysregulation in GH secretion. GH can regulate the expression of growth hormone receptor and strengthen the function of mitochondria, which could improve the quality of the female oocyte. In this study, a prospective randomized control will be conducted to explore the effect of GH adjuvant therapy on clinical outcome of in vitro fertilization.
Read the detailed description
Eligible subjects will be randomly assigned into either the study groups (receive somatropin co-treatment) or the control group (without sopmatropin treatment). Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) for approximately 6 weeks, i.e. from the beginning of preceding menstruation cycle until the day of ovum pickup. Both groups will receive a similar common protocol for ovarian stimulation. In vitro fertilization with or without intracytoplasmic sperm injection will be performed according to semen parameters. All embryos will undergo culture for blastocyst and the obtained blastocysts will be vitrified for deferred frozen embryo transfer. The Blastocyst formation rate will be the primary outcome measure.
- Conditions
- Poor Ovarian Reserve
- Being tested
- Polyethylene Glycol Recombinant Human Somatropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol Recombinant Human SomatropinDrug
Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) from the beginning of preceding menstruation cycle until the day of ovum pickup.
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormone group | Experimental | Growth Hormone pretreatment for 6 weeks before ovarian stimulation Receives: Drug: Polyethylene Glycol Recombinant Human Somatropin |
| Control group | No intervention | No pretreatment before ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst formation rate
the number of blastocyst/ the total number of embryos underwent blastocyst culture ×100%
Measured: One year
Live birth rate
Measured: One year
Secondary outcomes (8)
Number of retrieved oocytes
Measured: One year
Number of high-score embryos
Measured: One year
total amount of Gn used
Measured: One year
total days of Gn administration
Measured: One year
clinical pregnancy rate
Measured: One year
Ongoing pregnancy rate
Measured: One year
E2 levels on triggering day
Measured: One year
Endometrial thickness on triggering day
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion20 Mar 2022 (estimated)
- Study completion20 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Ovarian ReserveStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, The Second Hospital of Hebei Medical University
- Responsible party
- Principal investigator, Chen Zi-Jiang, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588844
- Sponsor's protocol ID
- PEG-rhGH
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and statistical analysis plan will be available online with publication. Data collected for the study, including specified data set and a data dictionary defining each field in the set, will be made available to others with publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Polyethylene Glycol Recombinant Human Growth Hormone Injection on the IVF/ICSI Outcome of Patients With Poor Ovarian Reserve
- ClinicalTrials.gov ID
- NCT04588844
- Acronym / sponsor ID
- PEG-rhGH
- Conditions
- Poor Ovarian Reserve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- RenJi Hospital, The Second Hospital of Hebei Medical University
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 19 Oct 2020 (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.
Declined fertility and ovarian reserve in older women are associated with lower density of Growth hormone (GH) receptors and dysregulation in GH secretion. GH can regulate the expression of growth hormone receptor and strengthen the function of mitochondria, which could improve the quality of the female oocyte. In this study, a prospective randomized control will be conducted to explore the effect of GH adjuvant therapy on clinical outcome of in vitro fertilization.
Detailed description
Eligible subjects will be randomly assigned into either the study groups (receive somatropin co-treatment) or the control group (without sopmatropin treatment). Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) for approximately 6 weeks, i.e. from the beginning of preceding menstruation cycle until the day of ovum pickup. Both groups will receive a similar common protocol for ovarian stimulation. In vitro fertilization with or without intracytoplasmic sperm injection will be performed according to semen parameters. All embryos will undergo culture for blastocyst and the obtained blastocysts will be vitrified for deferred frozen embryo transfer. The Blastocyst formation rate will be the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth Hormone group | Experimental | Drug: Polyethylene Glycol Recombinant Human SomatropinGrowth Hormone pretreatment for 6 weeks before ovarian stimulation |
| Control group | No intervention | –No pretreatment before ovarian stimulation |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1)Married women between 35-40 years old; 2) serum AMH< 1.2ng/ml, and basal FSH<20IU/L during the screening period or within 6 months; 3) 18kg/m2≤BMI<30kg/m2; 4) Previous ART cycles <3.
Key exclusion criteria (1 listed)
- 1）Gynecological diseases that affect pregnancy outcomes, such as submucous uterine myoma, intramural uterine myoma≥4cm, Ovarian cyst≥4cm, endometriosis, Uterine malformation, Tuberculosis of reproductive system; 2) Spontaneous abortion≥3 times; 3) Chromosomal abnormalities (except polymorphism) in one or both spouses; 4) Patients with well-defined and uncontrolled endocrine, metabolic, and adrenal diseases, such as diabetes, thyroid disease, Cushing's syndrome; 5) Patients with malignant tumors; 6) Previous use of somatropin products.
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 |
|---|---|---|
| Polyethylene Glycol Recombinant Human SomatropinPolyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) from the beginning of preceding menstruation cycle until the day of ovum pickup. | Drug | Growth Hormone group |
Primary outcome
Blastocyst formation rate
Time frame: One year
the number of blastocyst/ the total number of embryos underwent blastocyst culture ×100%
Live birth rate
Time frame: One year
8 secondary outcomes
Number of retrieved oocytes
Time frame: One year
Number of high-score embryos
Time frame: One year
total amount of Gn used
Time frame: One year
total days of Gn administration
Time frame: One year
clinical pregnancy rate
Time frame: One year
Ongoing pregnancy rate
Time frame: One year
E2 levels on triggering day
Time frame: One year
Endometrial thickness on triggering day
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: Yes. The study protocol and statistical analysis plan will be available online with publication. Data collected for the study, including specified data set and a data dictionary defining each field in the set, will be made available to others with publication.
Related trials for Poor Ovarian Reserve
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Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI
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Not yet recruiting
Impact of Day 2 Versus Day 3 Fresh Embryo Transfer on Live Birth Rate in Poor-Prognosis Patients
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Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene Glycol Recombinant Human Somatropin in people with Poor Ovarian Reserve, run by Shandong University.
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 1 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Daimin Wei (0531-85652419, sdweidaimin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastocyst formation rate (time frame: One year). 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?
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 19 Oct 2020.