Effect of GH on the Blastocyst Euploid Rate in AMA Patients

NCT05447208 | Recruiting Phase 3 DMC

• 1 other identifier: 2022JIAI-10
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Preimplantation Genetic Testing; Growth Hormone; Age, Parental

Outcome Measures

Primary Outcomes (1)

• euploidy rate

  euploidy rate of blastocysts

  1 month after oocyte retrieval

Secondary Outcomes (7)

• live birth rate

  1 year after embryo transfer

• cumulative live birth rate

  1 year after embryo transfer

• ongoing pregnancy

  12 weeks' gestation

• clinical pregnancy rate

  6 weeks after embryo transfer

• number of euploid blastocysts in an OS cycle

  1 month after oocyte retrieval

Study Arms (2)

Treatment group

EXPERIMENTAL

GH is supplemented during ovarian stimulation

Drug: Growth Hormone; Drug: GnRH antagonist

Control group

ACTIVE COMPARATOR

GH is not supplemented during ovarian stimulation.

Drug: GnRH antagonist

Interventions

Growth Hormone DRUG

Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval

Treatment group

GnRH antagonist DRUG

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

Control group; Treatment group

Eligibility Criteria

• Age: 38 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

Shanghai JIAI Genetics and IVF Institute

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Related 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.

  PMID: 26868992 BACKGROUND

• 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: 25376626 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.

  PMID: 33127971 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.

  PMID: 33621201 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.

  PMID: 33534048 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.

  PMID: 30503129 BACKGROUND

MeSH Terms

Interventions

Growth Hormone; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• XIAOXI SUN, PhD

  Shanghai JiAi Genetics & IVF Institute, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YILUN SUI, MD

CONTACT

86-13661553127; 08301010255@fudan.edu.cn

XIAOXI SUN, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The embryologists, genetic scientists, and the independent statistician will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 7, 2022
• Study Start: August 1, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available when beginning 3 months and ending 5 years following article publication
• Access Criteria: 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.

Locations

CN (1)