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NCT05447208·Phase 3·INTERVENTIONAL

Effect of GH on the Blastocyst Euploid Rate in AMA Patients

CetrorelixOtherRecruiting

Status

Recruiting

Phase

Phase 3

Enrollment

400

Locations

1

Results

Not posted

Publications

7

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Jul 7, 2022

  2. Study start

    Aug 1, 2022

  3. Primary completion

    Mar 1, 2026

  4. Study completion

    Dec 31, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Feb 12, 2025

Outcomes

What the study measures.

Primary outcomes

euploidy rate

Time frame · 1 month after oocyte retrieval

euploidy rate of blastocysts

Secondary outcomes

live birth rate

Time frame · 1 year after embryo transfer

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

cumulative live birth rate

Time frame · 1 year after embryo transfer

cumulative live birth within 6 months of randomization

ongoing pregnancy

Time frame · 12 weeks' gestation

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

clinical pregnancy rate

Time frame · 6 weeks after embryo transfer

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

number of euploid blastocysts in an OS cycle

Time frame · 1 month after oocyte retrieval

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

the probability of obtaining euploid blastocysts in an OS cycle

Time frame · 1 month after oocyte retrieval

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.

KIDScore of euploid embryos

Time frame · 6 days after oocyte retrieval

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

Eligibility

Who can take part.

Minimum age
38 Years
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: * Age ≥38; intended to undergo PGT-A * BMI in the normal range (18.50-24.0kg/m2) * Normal semen analysis for the male partner 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 * 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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Shanghai JIAI Genetics and IVF Institute

Shanghai, Shanghai Municipality, China

Publications

Results and literature.

PMID 26868992 ↗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.PMID 25376626 ↗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.PMID 33127971 ↗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.PMID 33621201 ↗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.PMID 33534048 ↗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.PMID 30503129 ↗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.PMID 41735936 ↗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.

Primary links

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ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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