Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study

ShangHai Ji Ai Genetics & IVF Institute

Status and phase: Completed; Phase 3

Conditions: Growth Hormone; PGT-A; Advanced Maternal Age

Treatments: Drug: GnRH antagonist; Drug: Growth hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT05574894

JIAI E2022-022

Details and patient eligibility

About

This retrospective cohort study aims to investigate the effects of recombinant human growth hormone (rh-GH) on the euploid status of preimplantation blastocysts in AMA patients.

Infertile patients aged 38-46 years old were recruited for study if they fulfill the inclusion criteria and do not have the exclusion criteria.

Treatment group: Women received growth hormone (GH) supplement during antagonist protocol for ovarian stimulation.

Control group: Women received antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts per stimulation cycle and per testing cycle.

Enrollment: 692 patients

Sex: Female

Ages: 38 to 46 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 38-46; BMI 18.5-24.0kg/m2; intended to undergo PGT-A; GnRH Antagonist protocol for ovarian stimulation; 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;
• Women who received other supplement drugs during ovarian stimulation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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692 participants in 2 patient groups

GH group

Experimental group

Description:

Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

Treatment:

Drug: Growth hormone

Drug: GnRH antagonist

Control group

Active Comparator group

Description:

No Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

Treatment:

Drug: GnRH antagonist