GHNCT04384744
To Explore the Effect of GH on Outcomes of IVF and Telomerase Activity of Granulosa Cells in Women With POR
An observational study of GH and Poor Ovarian Reserve Based on POSEIDON, run by Guangzhou First People's Hospital.
Trial summary
It is still a big difficult clinical problem for patients with poor ovarian reserve undergoing in vitro fertilization. The decrease in both quality and quantity of egg are the main cause for poor clinical prognosis. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- GH, Poor Ovarian Reserve Based on POSEIDON
- What is being tested?
- growth hormone
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2020to 30 Nov 2021
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population includes patients diagnosed as POR based on POSEIDON criteria and with low ovairan reserve, as well as patients with normal ovairan reserve seeking for ART help due to pelvic tubal factors.
Who may be able to join
- For patients with poor ovarian response, the criteria is based on POSEIDON criteria[1]:
- low ovarian reserve(AMH <1.2ng/ml, or AFC <5);
- younger than 40.
- For patients with normal ovarian reserve, the criteria is as follow:
- Patients who are between 20-40 years old;
- clinical diagnosis of non-functional fallopian tube;
- regular menstrual cycles.
Who cannot join
- BMI ≥28kg/m2;
- 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;
- adenomyosis or endometriosis confirmed by surgery;
- untreated abnormal intrauterine environment, such as uterine effusion, endometritis, etc;
- untreated hydrosalpinx;
- polycystic ovary syndrome.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: To Explore the Effect of Growth Hormone on Outcomes of in Vitro Fertilisation and Telomerase Activity of Granulosa Cells in Women With Poor Ovarian Response
It is still a big difficult clinical problem for patients with poor ovarian reserve undergoing in vitro fertilization. The decrease in both quality and quantity of egg are the main cause for poor clinical prognosis. Growth hormone (GH) is currently one of the main adjuvant for improving pregnancy outcomes in patients with POR, and the investigators' previous retrospective study suggested GH was effective in live birth rate in subgroup of patients with POR older than 35 years old. To further figure out the mechanism of GH effectiveness in POR patients and the effect on clinical outcomes in POR patients, the investigators designed this prospective observational cohort study.
- Conditions
- GH, Poor Ovarian Reserve Based on POSEIDON
- Being tested
- growth hormone
- Keywords
- growth hormone, POSEIDON, low ovarian reserve, prospective observational cohort study
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-POR | 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-POR | Participants diagnosed POR according to POSEIDON criteria with low reserve undergo IVF in our center with long protocol or antagonist protocol without GH adjuvant. | |
| NGH-NOR | Participants with normal ovarian 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.
clinical pregnancy rate
Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred.
Measured: 1-2 years
Secondary outcomes (2)
live birth rate
Live birth rate(%): number of live birth/ transferred cycle.
Measured: 1-2 years
number of oocytes retrieved
number of oocytes retrieved on day of OPU
Measured: 1-2 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 Nov 2021 (estimated)
- Study completion30 Nov 2021 (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
- 40 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
- NCT04384744
- Sponsor's protocol ID
- 2019001
- Status last verified
- Apr 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 Growth Hormone on Outcomes of in Vitro Fertilisation and Telomerase Activity of Granulosa Cells in Women With Poor Ovarian Response
- ClinicalTrials.gov ID
- NCT04384744
- Acronym / sponsor ID
- 2019001
- Conditions
- GH, Poor Ovarian Reserve Based on POSEIDON
- Keywords
- growth hormone, POSEIDON, low ovarian reserve, prospective observational cohort study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- 26 May 2020 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2021 (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.
It is still a big difficult clinical problem for patients with poor ovarian reserve undergoing in vitro fertilization. The decrease in both quality and quantity of egg are the main cause for poor clinical prognosis. Growth hormone (GH) is currently one of the main adjuvant for improving pregnancy outcomes in patients with POR, and the investigators' previous retrospective study suggested GH was effective in live birth rate in subgroup of patients with POR older than 35 years old. To further figure out the mechanism of GH effectiveness in POR patients and the effect on clinical outcomes in POR patients, the investigators designed this prospective observational cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GH-POR | – | Drug: growth hormoneParticipants 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-POR | – | –Participants diagnosed POR according to POSEIDON criteria with low reserve undergo IVF in our center with long protocol or antagonist protocol without GH adjuvant. |
| NGH-NOR | – | –Participants with normal ovarian reserve undergo IVF in our center with long protocol or antagonist protocol without GH adjuvant. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population includes patients diagnosed as POR based on POSEIDON criteria and with low ovairan reserve, as well as patients with normal ovairan reserve seeking for ART help due to pelvic tubal factors.
Key inclusion criteria (7 listed)
- low ovarian reserve(AMH <1.2ng/ml, or AFC <5);
- younger than 40.
- Patients who are between 20-40 years old;
- clinical diagnosis of non-functional fallopian tube;
- regular menstrual cycles.
Key exclusion criteria (7 listed)
- BMI ≥28kg/m2;
- 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;
- adenomyosis or endometriosis confirmed by surgery;
- 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-POR |
Primary outcome
clinical pregnancy rate
Time frame: 1-2 years
Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred.
2 secondary outcomes
live birth rate
Time frame: 1-2 years
number of oocytes retrieved
Time frame: 1-2 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 Poor Ovarian Reserve Based on POSEIDON, 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 7 inclusion and 7 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?
clinical pregnancy rate (time frame: 1-2 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 NCT04384744, 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.