Effect of GH on the Blastocyst Euploid Rate in AMA Patients

ShangHai Ji Ai Genetics & IVF Institute

Status and phase: Enrolling; Phase 3

Conditions: Preimplantation Genetic Testing; Growth Hormone; Age, Parental

Treatments: Drug: Growth Hormone; Drug: GnRH antagonist

Study type: Interventional

Funder types: Other

Identifiers

NCT05447208

2022JIAI-10

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 38 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Treatment group

Experimental group

Description:

GH is supplemented during ovarian stimulation

Treatment:

Drug: GnRH antagonist

Drug: Growth Hormone

Control group

Active Comparator group

Description:

GH is not supplemented during ovarian stimulation.

Treatment:

Drug: GnRH antagonist