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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | GH is supplemented during ovarian stimulation |
|
| Control group | Active Comparator | GH is not supplemented during ovarian stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth Hormone | Drug | Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval |
|
| Measure | Description | Time Frame |
|---|---|---|
| euploidy rate | euploidy rate of blastocysts | 1 month after oocyte retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| live birth rate | deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer | 1 year after embryo transfer |
| cumulative live birth rate | cumulative live birth within 6 months of randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YILUN SUI, MD | Contact | 86-13661553127 | 08301010255@fudan.edu.cn | |
| XIAOXI SUN, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| XIAOXI SUN, PhD | Shanghai JiAi Genetics & IVF Institute, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai JIAI Genetics and IVF Institute | Recruiting | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26868992 | Background | 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. | |
| 25376626 |
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Data will be available when beginning 3 months and ending 5 years following article publication
To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with. Proposals should be sent to 08301010255@fudan.edu.cn.
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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The embryologists, genetic scientists, and the independent statistician will be blinded to the group allocation.
| GnRH antagonist | Drug | GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger |
|
| 1 year after embryo transfer |
| ongoing pregnancy | a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer | 12 weeks' gestation |
| clinical pregnancy rate | the presence of intrauterine gestational sac by transvaginal ultrasound at 6 gestational weeks of the first frozen embryo transfer | 6 weeks after embryo transfer |
| 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 | 1 month after oocyte retrieval |
| 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. | 1 month after oocyte retrieval |
| KIDScore of euploid embryos | an AI-driven embryo score generated through the EmbryoViewer software relying on kinetic parameters and associated with embryo implantation potential | 6 days after oocyte retrieval |
| 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. |
| 33127971 | Background | 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. |
| 33621201 | Background | 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. |
| 33534048 | Background | 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. |
| 30503129 | Background | 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. |
| 41735936 | Derived | 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. |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |