Effect of GH on the Blastocyst Euploid Rate in AMA Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group
|
Drug: Growth Hormone
Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval
Drug: GnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
|
| Active Comparator: Control group
|
Drug: GnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
|
Outcome Measures
Primary Outcome Measures
- euploidy rate [1 month after oocyte retrieval]
euploidy rate of blastocysts
Secondary Outcome Measures
- live birth rate [1 year after embryo transfer]
deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer
- cumulative live birth rate [1 year after embryo transfer]
cumulative live birth within 6 months of randomization
- ongoing pregnancy [12 weeks' gestation]
a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer
Eligibility Criteria
Criteria
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;
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- ShangHai Ji Ai Genetics & IVF Institute
Investigators
- Principal Investigator: XIAOXI SUN, PhD, Shanghai JiAi Genetics & IVF Institute, China
Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2022JIAI-10