AzTrials
AzTrials

Preimplantation Genetic TestingPhase 3NCT05447208

Effect of GH on the Blastocyst Euploid Rate in AMA Patients

A Phase 3 study testing Growth Hormone and GnRH antagonist in people with Preimplantation Genetic Testing and Growth Hormone, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This randomized trial aims to compare the euploid rate of blastocysts in AMA patients undergoing PGT-A (preimplantation genetic testing for aneuploidy) with or without growth hormone supplement. Read more about this study

Who is it for?
Ages 38 years and older, women only
What is being tested?
Growth Hormone and GnRH antagonist
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteChina
Study dates
1 Aug 2022to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥38; intended to undergo PGT-A
  • BMI in the normal range (18.50-24.0kg/m2)
  • 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
  • History of endocrine disorder, autoimmune diseases or diagnosed thrombophilia
  • History of GH supplementation in the previous IVF treatment or taking other supplementary drugs used during stimulation; patients with absolute or relative contraindications to GH treatment, including active malignancy or history of cancer, diabetic retinopathy, diabetes mellitus, and chronic kidney disease.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

YILUN SUI, MD contact

86-13661553127

08301010255@fudan.edu.cn

XIAOXI SUN, PhD contact

China1 site, 1 recruiting

  • Shanghai JIAI Genetics and IVF Institute

    Shanghai, Shanghai Municipality, 200011

    Xiaoxi Sun, PhD, 63459977, xiaoxi__sun@163.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized Control Trial to Investigate the Effect of Growth Hormone on the Euploid Rate of Blastocyst in Patients With Advanced Maternal Age

This randomized trial aims to compare the euploid rate of blastocysts in AMA patients undergoing PGT-A (preimplantation genetic testing for aneuploidy) with or without growth hormone supplement.

Infertile patients ≥38 years old will be recruited for study after informed consent if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups:

Treatment group: Women will receive growth hormone (GH) supplement before and during antagonist protocol for ovarian stimulation.

Control group: Women will receive antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts.

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 before and during the ovarian stimulation till the day of oocyte retrieval

  • GnRH antagonistDrug

    GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger

Study groups in NCT05447208
Study groupRoleWhat they receive
Treatment groupExperimentalGH is supplemented during ovarian stimulation
Receives: Drug: Growth Hormone; Drug: GnRH antagonist
Control groupActive comparatorGH is not supplemented during ovarian stimulation.
Receives: Drug: GnRH antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. euploidy rate

    euploidy rate of blastocysts

    Measured: 1 month after oocyte retrieval

Secondary outcomes (7)

  1. live birth rate

    deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer

    Measured: 1 year after embryo transfer

  2. cumulative live birth rate

    cumulative live birth within 6 months of randomization

    Measured: 1 year after embryo transfer

  3. ongoing pregnancy

    a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer

    Measured: 12 weeks' gestation

  4. clinical pregnancy rate

    the presence of intrauterine gestational sac by transvaginal ultrasound at 6 gestational weeks of the first frozen embryo transfer

    Measured: 6 weeks after embryo transfer

  5. number of euploid blastocysts in an OS cycle

    the number of blastocysts acquired in an ovarian stimulation cycle that are identified as euploid by PGT-A

    Measured: 1 month after oocyte retrieval

  6. the probability of obtaining euploid blastocysts in an OS cycle

    If the ovarian stimulation cycle produces euploid blastocysts, the result is 1; if not, it's 0. Mean values will be calculated for the two groups.

    Measured: 1 month after oocyte retrieval

  7. KIDScore of euploid embryos

    an AI-driven embryo score generated through the EmbryoViewer software relying on kinetic parameters and associated with embryo implantation potential

    Measured: 6 days after oocyte retrieval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start1 Aug 2022
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05447208
Sponsor's protocol ID
2022JIAI-10
Status last verified
Feb 2025
First submitted
3 Jul 2022
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Demko ZP, Simon AL, McCoy RC, Petrov DA, Rabinowitz M. Effects of maternal age on euploidy rates in a large cohort of embryos analyzed with 24-chromosome single-nucleotide polymorphism-based preimplantation genetic screening. Fertil Steril. 2016 May;105(5):1307-1313. doi: 10.1016/j.fertnstert.2016.01.025. Epub 2016 Feb 8.

    PubMed 26868992

  • Weall BM, Al-Samerria S, Conceicao J, Yovich JL, Almahbobi G. A direct action for GH in improvement of oocyte quality in poor-responder patients. Reproduction. 2015 Feb;149(2):147-54. doi: 10.1530/REP-14-0494. Epub 2014 Nov 5.

    PubMed 25376626

  • Gong Y, Luo S, Fan P, Jin S, Zhu H, Deng T, Quan Y, Huang W. Growth hormone alleviates oxidative stress and improves oocyte quality in Chinese women with polycystic ovary syndrome: a randomized controlled trial. Sci Rep. 2020 Oct 30;10(1):18769. doi: 10.1038/s41598-020-75107-4.

    PubMed 33127971

  • Liu C, Li S, Li Y, Tian J, Sun X, Song T, Yan G, Ding L, Sun H. Growth hormone ameliorates the age-associated depletion of ovarian reserve and decline of oocyte quality via inhibiting the activation of Fos and Jun signaling. Aging (Albany NY). 2021 Feb 17;13(5):6765-6781. doi: 10.18632/aging.202534. Epub 2021 Feb 17.

    PubMed 33621201

  • Skillern A, Leonard W, Pike J, Mak W. Growth hormone supplementation during ovarian stimulation improves oocyte and embryo outcomes in IVF/PGT-A cycles of women who are not poor responders. J Assist Reprod Genet. 2021 May;38(5):1055-1060. doi: 10.1007/s10815-021-02088-2. Epub 2021 Feb 3.

    PubMed 33534048

  • Regan SLP, Knight PG, Yovich JL, Arfuso F, Dharmarajan A. Growth hormone during in vitro fertilization in older women modulates the density of receptors in granulosa cells, with improved pregnancy outcomes. Fertil Steril. 2018 Dec;110(7):1298-1310. doi: 10.1016/j.fertnstert.2018.08.018.

    PubMed 30503129

  • Sui Y, Zou Y, Xiao M, Fu J, Li L, Sun X. The effect of growth hormone on the euploid rate of blastocysts in patients with advanced maternal age: study protocol for a single-blinded randomized controlled trial. BMC Pregnancy Childbirth. 2026 Feb 25;26(1):359. doi: 10.1186/s12884-026-08853-4.

    PubMed 41735936

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Growth Hormone and GnRH antagonist in people with Preimplantation Genetic Testing and Growth Hormone, 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 3 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact YILUN SUI, MD (86-13661553127, 08301010255@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

euploidy rate (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 NCT05447208, which also lists 7 linked publications.

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 12 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in