Growth HormonePhase 3NCT05574894
Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study
A Phase 3 study testing Growth hormone and GnRH antagonist in people with Growth Hormone and Advanced Maternal Age, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
Trial summary
This retrospective cohort study aims to investigate the effects of recombinant human growth hormone (rh-GH) on the euploid status of preimplantation blastocysts in AMA patients. Infertile patients aged 38-46 years old were recruited for study if they fulfill the inclusion criteria and do not have the exclusion… Read more about this study
- Who is it for?
- Ages 38 to 46 years, women only
- Conditions the study is for
- Growth Hormone, Advanced Maternal Age, PGT-A
- What is being tested?
- Growth hormone and GnRH antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 692 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Sep 2022
- Phase
- Phase 3
- 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 38 to 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 38-46; BMI 18.5-24.0kg/m2; intended to undergo PGT-A; GnRH Antagonist protocol for ovarian stimulation; normal semen analysis for the male partner
Who cannot join
- Endometriosis grade 3 or higher, untreat hydrosalpinx;
- Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex);
- Untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)
- Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease;
- Women who received other supplement drugs during ovarian stimulation
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai JIAI Genetics and IVF Institute
Shanghai, Shanghai Municipality, 200011
About this study
This retrospective cohort study aims to investigate the effects of recombinant human growth hormone (rh-GH) on the euploid status of preimplantation blastocysts in AMA patients.
Infertile patients aged 38-46 years old were recruited for study if they fulfill the inclusion criteria and do not have the exclusion criteria.
Treatment group: Women received growth hormone (GH) supplement during antagonist protocol for ovarian stimulation.
Control group: Women received antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts per stimulation cycle and per testing cycle.
- Conditions
- Growth Hormone, Advanced Maternal Age, PGT-A
- Being tested
- Growth hormone, GnRH antagonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormoneDrug
Growth hormone is supplemented during the ovarian stimulation till the day of trigger
GnRH antagonistDrug
GnRH antagonist protocol for ovarian stimulation
| Study group | Role | What they receive |
|---|---|---|
| GH group | Experimental | Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation Receives: Drug: Growth hormone; Drug: GnRH antagonist |
| Control group | Active comparator | No Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation Receives: Drug: GnRH antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cycles which obtained euploid blastocysts
Number of cycles with at least 1 euploid blastocyst divided by the total number of stimulation cycles in a cohort
Measured: 1 month after oocyte retrieval
Secondary outcomes (2)
Euploid blastocyst rate per cohort
Total number of euploid blastocyst in a cohort/total number of biopsied embryos in the same cohort
Measured: 1 month after oocyte retrieval
Euploidy rate per cycle
Euploidy rate of blastocysts, calculated per stimulation cycle and per testing cycle
Measured: 1 month after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Sep 2022
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 Growth HormoneStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoxi Sun, PhD, Study director, Shanghai JIAI Genetics and IVF Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574894
- Sponsor's protocol ID
- JIAI E2022-022
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sui Y, Xiao M, Fu J, Li L, Xu Y, Lei C, Sun X. Growth hormone supplementation during ovarian stimulation in women with advanced maternal age undergoing preimplantation genetic testing for Aneuploidy. J Ovarian Res. 2023 Oct 19;16(1):204. doi: 10.1186/s13048-023-01279-y.
PubMed 37858247
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05574894
- Acronym / sponsor ID
- JIAI E2022-022
- Conditions
- Growth Hormone, Advanced Maternal Age, PGT-A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 692 participants (actual)
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF InstituteUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 12 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 retrospective cohort study aims to investigate the effects of recombinant human growth hormone (rh-GH) on the euploid status of preimplantation blastocysts in AMA patients.
Infertile patients aged 38-46 years old were recruited for study if they fulfill the inclusion criteria and do not have the exclusion criteria.
Treatment group: Women received growth hormone (GH) supplement during antagonist protocol for ovarian stimulation.
Control group: Women received antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts per stimulation cycle and per testing cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GH group | Experimental | Drug: Growth hormone, Drug: GnRH antagonistGrowth Hormone supplement, GnRH antagonist protocol for ovarian stimulation |
| Control group | Active comparator | Drug: GnRH antagonistNo Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation |
Who may qualify
- Ages
- 38 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 38-46; BMI 18.5-24.0kg/m2; intended to undergo PGT-A; GnRH Antagonist protocol for ovarian stimulation; normal semen analysis for the male partner
Key exclusion criteria (5 listed)
- Endometriosis grade 3 or higher, untreat hydrosalpinx;
- Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex);
- Untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)
- Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease;
- Women who received other supplement drugs during ovarian stimulation
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 is supplemented during the ovarian stimulation till the day of trigger | Drug | GH group |
| GnRH antagonistGnRH antagonist protocol for ovarian stimulation | Drug | Control group, GH group |
Primary outcome
Proportion of cycles which obtained euploid blastocysts
Time frame: 1 month after oocyte retrieval
Number of cycles with at least 1 euploid blastocyst divided by the total number of stimulation cycles in a cohort
2 secondary outcomes
Euploid blastocyst rate per cohort
Time frame: 1 month after oocyte retrieval
Euploidy rate per cycle
Time frame: 1 month after oocyte retrieval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 37858247Sui Y, Xiao M, Fu J, Li L, Xu Y, Lei C, Sun X. Growth hormone supplementation during ovarian stimulation in women with advanced maternal age undergoing preimplantation genetic testing for Aneuploidy. J Ovarian Res. 2023 Oct 19;16(1):204. doi: 10.1186/s13048-023-01279-y.
- 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.
Xiaoxi Sun, PhD study director
Shanghai JIAI Genetics and IVF Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Growth hormone and GnRH antagonist in people with Growth Hormone and Advanced Maternal Age, run by ShangHai Ji Ai Genetics & IVF Institute 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 1 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: finished, as of the sponsor's last update on 21 Feb 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cycles which obtained euploid blastocysts (time frame: 1 month after oocyte retrieval). 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 NCT05574894, 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 Feb 2023.