Low Ovarian ReservePhase 4NCT03027843
The Effect of Growth Hormone in Assisted Reproductive Technology Clinical Outcome of Poor Responder
A Phase 4 study testing Growth Hormone in people with Low Ovarian Reserve, run by Sun Yat-sen University.
Trial summary
Assisted reproduction treatment in patients with low ovarian reserve is a big difficult clinical problem. Growth hormone (GH) is crucial in the development of follicles since preantral follicle to ovulation and can promote steroid hormones and gamete formation, increase the granular cell sensitivity,and inhibition of… Read more about this study
- Who is it for?
- Ages 30 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Ovarian Reserve
- What is being tested?
- Growth Hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Apr 2020
- Phase
- Phase 4
- 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 30 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age ≥35 years and ≤40 years.
- 2≤ AFC≤6, and AMH level ≥0.5 and≤ 1.1 ng/ml.
- Previous failed transfer cycle ≥2
- Didn't participate in other clinical subjects in three months.
- Written informed consent.
Who cannot join
- Body mass index (BMI) ≥25 kg/m2.
- Endocrine metabolic disease, such as diabetes, insulin resistance, hyperthyroidism, Cushing's syndrome, hyperprolactinemia.
- Hypertension (systolic blood pressure ≥140mmHg and diastolic blood pressure≥90mmHg.
- Autoimmune diseases was definitively diagnosed, such as systemic lupus erythematosus, Sjogren's syndrome, Hashimoto's Thyroiditis, multiple sclerosis, rheumatoid arthritis, autoimmune hemolytic anemia, recurrent miscarriage.
- Ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery.
- Complicated with adenomyosis, endometriosis confirmed by surgery, ovarian endometriosis cyst ≥2 cm by ultrasound, all kind of malignant tumors or precancerous disease.
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- Untreated hydrosalpinx.
- Eliminate or falls off Criteria:
- Withdraw drug and take appropriate treatment measures if serious adverse events happen during the trial, and subjects will be off.
- Patients that have bad compliance.
- Subjects are found breach the inclusion criteria, or in accordance with exclusion criteria during the test, excluded.
- Patients request withdrawal and exit the trial because adverse events occur during the trial.
- No record about treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Study of the Effect of Growth Hormone in Assisted Reproductive Technology Clinical Outcome of Poor Responder
Assisted reproduction treatment in patients with low ovarian reserve is a big difficult clinical problem. Growth hormone (GH) is crucial in the development of follicles since preantral follicle to ovulation and can promote steroid hormones and gamete formation, increase the granular cell sensitivity,and inhibition of follicular atresia. Latest research shows that GH can improve egg quality through regulating mitochondrial function of the oocytes and increase the rate of embryo euploid. It becomes a new argument in that promotion of clinical pregnancy rate in assisted reproduction treatment. GH applied in the field of assisted reproduction 30 years experience of applicable people, but drug dosage, drug intervention time continue to explore. 2015 China assisted reproductive stimulate ovulation medicine expert consensus recommend joint GH for poor ovarian response, repeated implantation failure patients and older patients assisted fertility treatment, but not on the specific use time limit, the daily dose of drugs and curative effect. How to maximize growth hormone potential advantage in improving the egg quality bothers the clinical doctors. We had a self-controlled retrospective analyses in growth hormone application and found that the average daily injections of GH dose 2 iu for 45 days can significantly improve the embryo quality in patients with low ovarian reaction. And now long-acting recombinant human growth hormone is available, which make it convenient for patients. A forward-looking experimental is expected to answer clinical practical problems and provide proper GH regimen for low ovarian responder.
Read the detailed description
This study is a pilot study to investigate the effect of growth hormone in assisted reproductive technology clinical outcome of poor responder.
Design: randomized controlled trial. Setting: Assisted reproductive technologies unit. Patients: patients diagnosed poor ovarian responder who is in accordance with the inclusion criteria, and not meet the exclusion criteria, who had repeated IVF treatment from Mar 2017 to Aug 2019.
Intervention: The comparison was made between GH group and the control group, both groups are conducted with the mini-dose GnRH-a long protocol for IVF treatment. GH group use Long-acting recombinant human growth hormone 14IU qw, until the day of hCG.
Main outcome measures: The primary outcome of the study is live birth rate. The secondary outcomes were clinical pregnancy rate, number of oocytes retrieved, fertility rate, normal fertilization rate, rate of transferable embryo and good quality embryo rate.
- Conditions
- Low Ovarian Reserve
- Being tested
- Growth Hormone
- Keywords
- low ovarian reserve, growth hormone, embryo quality, live birth, clinical pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth HormoneDrug
Also called somatotropin;GH;somatotrophin;somatotropic
in GH group, patients have weekly injections of GH dose 14 iu, until the day of hCG.
| Study group | Role | What they receive |
|---|---|---|
| GH group | Active comparator | patients in group mini-dose GnRH-a long protocol combine with growth hormone Receives: Drug: Growth Hormone |
| control group | No intervention | patients in group mini-dose GnRH-a long protocol without growth hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
Live birth rate(%): number of live birth/ transferred cycle.Compare the live birth rate between the two group with SPSS 20.0.
Measured: 1-2year
Secondary outcomes (6)
clinical pregnancy rate
Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred. Clinical pregnancy rate(%): number of clinical pregnancy/transferred cycle.Compare the clinical pregnancy rate between the two group with SPSS 20.0.
Measured: 1-2 year
number of oocytes retrieved
Compare the number of oocytes retrieved between the two group with SPSS 20.0.
Measured: 1-2 year
fertility rate
Fertility rate(%): number of occyte fertilized/ number of oocytes retrieved. Compare the fertility rate between the two group with SPSS 20.0.
Measured: 1-2 year
normal fertility rate
Normal fertility rate(%): number of occyte normally fertilized/ number of oocytes retrieved. Compare the normal fertility rate between the two group with SPSS 20.0.
Measured: 1-2 year
transferable embryo rate
Cleavage embryo grades 1 or 2 with at least 5 blastomeres are considered as transferrable embryo.Transferable embryo rate(%): number of transferable embryo/number of feritilized oocytes. Compare the transferable embryo rate between the two group with SPSS 20.0.
Measured: 1-2 year
good quality embryo rate
Cleavage embryo grades 1 or 2 with 6-10 blastomeres were considered good quality embryos. Good quality embryo rate(%): number of good quality embryo/number of feritilized oocytes.Compare the good quality embryo rate between the two group with SPSS 20.0.
Measured: 1-2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startMar 2017 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionApr 2020 (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 Low Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Xing Yang, M.D. & Ph.D., Study director, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027843
- Sponsor's protocol ID
- newivf20170110
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sood A, Mohiyiddeen G, Ahmad G, Fitzgerald C, Watson A, Mohiyiddeen L. Growth hormone for in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD000099. doi: 10.1002/14651858.CD000099.pub4.
PubMed 34808697
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Growth Hormone in Assisted Reproductive Technology Clinical Outcome of Poor Responder
- ClinicalTrials.gov ID
- NCT03027843
- Acronym / sponsor ID
- newivf20170110
- Conditions
- Low Ovarian Reserve
- Keywords
- low ovarian reserve, growth hormone, embryo quality, live birth, clinical pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 23 Jan 2017 (estimated)
- 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.
Assisted reproduction treatment in patients with low ovarian reserve is a big difficult clinical problem. Growth hormone (GH) is crucial in the development of follicles since preantral follicle to ovulation and can promote steroid hormones and gamete formation, increase the granular cell sensitivity,and inhibition of follicular atresia. Latest research shows that GH can improve egg quality through regulating mitochondrial function of the oocytes and increase the rate of embryo euploid. It becomes a new argument in that promotion of clinical pregnancy rate in assisted reproduction treatment. GH applied in the field of assisted reproduction 30 years experience of applicable people, but drug dosage, drug intervention time continue to explore. 2015 China assisted reproductive stimulate ovulation medicine expert consensus recommend joint GH for poor ovarian response, repeated implantation failure patients and older patients assisted fertility treatment, but not on the specific use time limit, the daily dose of drugs and curative effect. How to maximize growth hormone potential advantage in improving the egg quality bothers the clinical doctors. We had a self-controlled retrospective analyses in growth hormone application and found that the average daily injections of GH dose 2 iu for 45 days can significantly improve the embryo quality in patients with low ovarian reaction. And now long-acting recombinant human growth hormone is available, which make it convenient for patients. A forward-looking experimental is expected to answer clinical practical problems and provide proper GH regimen for low ovarian responder.
Detailed description
This study is a pilot study to investigate the effect of growth hormone in assisted reproductive technology clinical outcome of poor responder.
Design: randomized controlled trial. Setting: Assisted reproductive technologies unit. Patients: patients diagnosed poor ovarian responder who is in accordance with the inclusion criteria, and not meet the exclusion criteria, who had repeated IVF treatment from Mar 2017 to Aug 2019.
Intervention: The comparison was made between GH group and the control group, both groups are conducted with the mini-dose GnRH-a long protocol for IVF treatment. GH group use Long-acting recombinant human growth hormone 14IU qw, until the day of hCG.
Main outcome measures: The primary outcome of the study is live birth rate. The secondary outcomes were clinical pregnancy rate, number of oocytes retrieved, fertility rate, normal fertilization rate, rate of transferable embryo and good quality embryo rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH group | Active comparator | Drug: Growth Hormonepatients in group mini-dose GnRH-a long protocol combine with growth hormone |
| control group | No intervention | –patients in group mini-dose GnRH-a long protocol without growth hormone |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women age ≥35 years and ≤40 years.
- 2≤ AFC≤6, and AMH level ≥0.5 and≤ 1.1 ng/ml.
- Previous failed transfer cycle ≥2
- Didn't participate in other clinical subjects in three months.
- Written informed consent.
Key exclusion criteria (13 listed)
- Body mass index (BMI) ≥25 kg/m2.
- Endocrine metabolic disease, such as diabetes, insulin resistance, hyperthyroidism, Cushing's syndrome, hyperprolactinemia.
- Hypertension (systolic blood pressure ≥140mmHg and diastolic blood pressure≥90mmHg.
- Autoimmune diseases was definitively diagnosed, such as systemic lupus erythematosus, Sjogren's syndrome, Hashimoto's Thyroiditis, multiple sclerosis, rheumatoid arthritis, autoimmune hemolytic anemia, recurrent miscarriage.
- Ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery.
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: somatotropin;GH;somatotrophin;somatotropicin GH group, patients have weekly injections of GH dose 14 iu, until the day of hCG. | Drug | GH group |
Primary outcome
live birth rate
Time frame: 1-2year
Live birth rate(%): number of live birth/ transferred cycle.Compare the live birth rate between the two group with SPSS 20.0.
6 secondary outcomes
clinical pregnancy rate
Time frame: 1-2 year
number of oocytes retrieved
Time frame: 1-2 year
fertility rate
Time frame: 1-2 year
normal fertility rate
Time frame: 1-2 year
transferable embryo rate
Time frame: 1-2 year
good quality embryo rate
Time frame: 1-2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Derived from this study: PubMed 34808697Sood A, Mohiyiddeen G, Ahmad G, Fitzgerald C, Watson A, Mohiyiddeen L. Growth hormone for in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD000099. doi: 10.1002/14651858.CD000099.pub4.
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Impact of Day 2 Versus Day 3 Fresh Embryo Transfer on Live Birth Rate in Poor-Prognosis Patients
POSEIDON Category 4, Low Prognosis in Assisted Reproductive Technology
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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.
Xing Yang, M.D. & Ph.D. study director
Sixth Affiliated Hospital, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Growth Hormone in people with Low Ovarian Reserve, run by Sun Yat-sen 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 5 inclusion and 13 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 23 Jan 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xing Yang, M.D. & Ph.D. (020-38048013, yxing_8358@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: 1-2year). 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 NCT03027843, 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 23 Jan 2017.