GHNCT04384783
To Explore the Effect of GH Pretreatment on Clinical Outcomes in Patients With Low Ovarian Reserve
An observational study of GH and Low Ovarian Reserve, run by Guangzhou First People's Hospital.
Trial summary
Growth hormone (GH) has been used in the field of assisted reproduction technology for over 30 years. Studies for GH have been exploring in the applicable population, drug dosage, starting time and time limitation. In previous clinical applications, it worked as an adjuvant drug for improving ovarian reactivity. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- GH, Low Ovarian Reserve
- What is being tested?
- growth hormone
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2020to 30 Apr 2022
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients enroll for study are based on POSEIDON criteria[1], and with informed consent.
Who may be able to join
- low ovarian reserve(AMH <1.2ng/ml, or AFC <5);
- patients who have not participated in any clinical trials within the three months;
- patients who voluntarily signed informed consent.
Who cannot join
- patients with BMI ≥30kg/m2;
- patients with medical diseases such as endocrine and metabolic diseases, autoimmune disease, etc;
- ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery;
- complicated with adenomyosis, endometriosis confirmed by surgery;
- patients with untreated abnormal intrauterine environment, such as uterine effusion, endometritis, etc;
- untreated hydrosalpinx.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: To Explore the Effect of Low-dose Long Term Growth Hormone Pretreatment on Clinical Pregnancy Outcomes in Patients With Low Ovarian Reserve
Growth hormone (GH) has been used in the field of assisted reproduction technology for over 30 years. Studies for GH have been exploring in the applicable population, drug dosage, starting time and time limitation. In previous clinical applications, it worked as an adjuvant drug for improving ovarian reactivity. With the development of basic research and clinical applications, the improvement effect on egg quality is gradually recognized. However, which protocol of GH may work well and maximize the clinical effect remains mystery. The investigators' previous self-controlled retrospective research about 380 cases treated with GH found that the average daily injection of GH dose of 2IU for about 6 weeks can significantly improve embryo quality and clinical pregnancy outcomes of the patients with low ovarian response. The new POSEIDON standard clearly groups people with low prognosis and better classifies heterogeneous people, which may help classifying the specific subgroup that benefit most from GH of poor ovarian response (POR). The investigators design a prospective cohort study to explore whether GH low-dose long-term pretreatment can improve the outcome of assisted pregnancy and its possible mechanism in people with low ovarian reserve.
- Conditions
- GH, Low Ovarian Reserve
- Being tested
- growth hormone
- Keywords
- GH, low ovarian reserve, POSEIDON
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
growth hormoneDrug
growth hormone was adjuvanted 2IU/d from previous menstrual period for about six weeks.
| Study group | Role | What they receive |
|---|---|---|
| GH group | GH group: Participants diagnosed POR according to POSEIDON criteria with low ovarian reserve undergo IVF in our center with long protocol or antagonist protocol and is adjuvant with GH 2IU/d from previous menstrual period for about six weeks. Receives: Drug: growth hormone | |
| NGH group | NGH (non-GH) group: Participants diagnosed POR according to POSEIDON criteria with low reserve undergo IVF in our center with long protocol or antagonist protocol without GH adjuvant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of good quality embryos
the number of good quality embryos divide by the number of transferrable embryos
Measured: 2 years
Secondary outcomes (4)
number of oocytes retrieved
number of oocytes retrieved
Measured: 2 years
fertilization rate
the fertilized oocytes divided by the number of oocytes retrieved
Measured: 2 years
clinical pregnancy rate
the patients confirmed clinical pregnancy divided by the patients undergoing fresh embryo transferred.
Measured: 2 years
live birth rate
the patients have a live birth divided by the patients undergoing fresh embryo transferred.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start26 May 2020 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 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 GHStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- meihong Cai, master, Study director, Guangzhou First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384783
- Sponsor's protocol ID
- 20201A011002
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.
PubMed 26921622
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Effect of Low-dose Long Term Growth Hormone Pretreatment on Clinical Pregnancy Outcomes in Patients With Low Ovarian Reserve
- ClinicalTrials.gov ID
- NCT04384783
- Acronym / sponsor ID
- 20201A011002
- Conditions
- GH, Low Ovarian Reserve
- Keywords
- GH, low ovarian reserve, POSEIDON
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- 26 May 2020 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 12 May 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.
Growth hormone (GH) has been used in the field of assisted reproduction technology for over 30 years. Studies for GH have been exploring in the applicable population, drug dosage, starting time and time limitation. In previous clinical applications, it worked as an adjuvant drug for improving ovarian reactivity. With the development of basic research and clinical applications, the improvement effect on egg quality is gradually recognized. However, which protocol of GH may work well and maximize the clinical effect remains mystery. The investigators' previous self-controlled retrospective research about 380 cases treated with GH found that the average daily injection of GH dose of 2IU for about 6 weeks can significantly improve embryo quality and clinical pregnancy outcomes of the patients with low ovarian response. The new POSEIDON standard clearly groups people with low prognosis and better classifies heterogeneous people, which may help classifying the specific subgroup that benefit most from GH of poor ovarian response (POR). The investigators design a prospective cohort study to explore whether GH low-dose long-term pretreatment can improve the outcome of assisted pregnancy and its possible mechanism in people with low ovarian reserve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH group | – | Drug: growth hormoneGH group: Participants diagnosed POR according to POSEIDON criteria with low ovarian reserve undergo IVF in our center with long protocol or antagonist protocol and is adjuvant with GH 2IU/d from previous menstrual period for about six weeks. |
| NGH group | – | –NGH (non-GH) group: Participants diagnosed POR according to POSEIDON criteria with low reserve undergo IVF in our center with long protocol or antagonist protocol without GH adjuvant. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients enroll for study are based on POSEIDON criteria[1], and with informed consent.
Key inclusion criteria (3 listed)
- low ovarian reserve(AMH <1.2ng/ml, or AFC <5);
- patients who have not participated in any clinical trials within the three months;
- patients who voluntarily signed informed consent.
Key exclusion criteria (6 listed)
- patients with BMI ≥30kg/m2;
- patients with medical diseases such as endocrine and metabolic diseases, autoimmune disease, etc;
- ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery;
- complicated with adenomyosis, endometriosis confirmed by surgery;
- patients with untreated abnormal intrauterine environment, such as uterine effusion, endometritis, etc;
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 hormonegrowth hormone was adjuvanted 2IU/d from previous menstrual period for about six weeks. | Drug | GH group |
Primary outcome
rate of good quality embryos
Time frame: 2 years
the number of good quality embryos divide by the number of transferrable embryos
4 secondary outcomes
number of oocytes retrieved
Time frame: 2 years
fertilization rate
Time frame: 2 years
clinical pregnancy rate
Time frame: 2 years
live birth rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Results publication: PubMed 26921622Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.
- Individual participant dataSharing planned: No
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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.
meihong Cai, master study director
Guangzhou First People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of GH and Low Ovarian Reserve, run by Guangzhou First People's Hospital.
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 3 inclusion and 6 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 21 May 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 meihong Cai, master (15889936054, caimhong@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of good quality embryos (time frame: 2 years). 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 NCT04384783, 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 21 May 2020.