Effect of GH on the Blastocyst Euploid Rate in AMA Patients

Growth Hormone Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447208
• Other study ID #: 2022JIAI-10
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: July 2022
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: YILUN SUI, MD
• Phone: 86-13661553127
• Email: 08301010255[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 38 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age =38; intended to undergo PGT-A

Exclusion Criteria:

• 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;

Related Conditions & MeSH terms

• Age, Parental
• Growth Hormone
• Preimplantation Genetic Testing

Intervention

Drug:
• Growth Hormone
Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval
• GnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger

Locations

Country	Name	City	State
China	Shanghai JIAI Genetics and IVF Institute	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	euploidy rate	euploidy rate of blastocysts	1 month after oocyte retrieval
Secondary	live birth rate	deliveries =22 weeks gestation with heartbeat and breath of the first frozen embryo transfer	1 year after embryo transfer
Secondary	cumulative live birth rate	cumulative live birth within 6 months of randomization	1 year after embryo transfer
Secondary	ongoing pregnancy	a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer	12 weeks' gestation