Effect of GH on the Blastocyst Euploid Rate in AMA Patients

NCT05447208 · tracked via the Priya Life Science China tracker

Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Phase

Phase 3

Started

2022-08-01

Last updated

2025-02-12

Condition(s) studied

Preimplantation Genetic TestingGrowth HormoneAge, Parental

Investigational drug(s) / intervention(s)

Growth HormoneGnRH antagonist

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

Study 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.

Eligibility

Sex

FEMALE

Min age

38 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

euploidy rate — 1 month after oocyte retrieval
euploidy rate of blastocysts

Trial sites (1)

Facility	City	Region	Status
Shanghai JIAI Genetics and IVF Institute	Shanghai	Shanghai Municipality	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05447208 on ClinicalTrials.gov ↗ ← All trials in China