Effect of GH on the Blastocyst Euploid Rate in AMA Patients

Phase 3RecruitingNCT05447208

ShangHai Ji Ai Genetics & IVF Institute400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

400

Conditions

Preimplantation Genetic Testing Growth Hormone Age, Parental

Interventions

Eligibility

Sex: FEMALEMin age: 38 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

euploidy rate

euploidy rate of blastocysts

Time frame: 1 month after oocyte retrieval

Secondary Outcomes

live birth rate

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

Time frame: 1 year after embryo transfer

cumulative live birth rate

cumulative live birth within 6 months of randomization

Time frame: 1 year after embryo transfer

ongoing pregnancy

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

Time frame: 12 weeks' gestation

clinical pregnancy rate

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

Time frame: 6 weeks after embryo transfer

number of euploid blastocysts in an OS cycle

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

Time frame: 1 month after oocyte retrieval

the probability of obtaining euploid blastocysts in an OS cycle

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.

Time frame: 1 month after oocyte retrieval

KIDScore of euploid embryos

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

Time frame: 6 days after oocyte retrieval

Effect of GH on the Blastocyst Euploid Rate in AMA Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts