Effect of GH on the Blastocyst Euploid Rate in AMA Patients
- Conditions
- Age, ParentalPreimplantation Genetic TestingGrowth Hormone
- Interventions
- Registration Number
- NCT05447208
- Lead Sponsor
- ShangHai Ji Ai Genetics & IVF Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 400
- Age ≥38; intended to undergo PGT-A
- BMI in the normal range (18.50-24.0kg/m2)
- Normal semen analysis for the male partner
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group GnRH antagonist GH is not supplemented during ovarian stimulation. Treatment group Growth Hormone GH is supplemented during ovarian stimulation Treatment group GnRH antagonist GH is supplemented during ovarian stimulation
- Primary Outcome Measures
Name Time Method euploidy rate 1 month after oocyte retrieval euploidy rate of blastocysts
- Secondary Outcome Measures
Name Time Method live birth rate 1 year after embryo transfer deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer
cumulative live birth rate 1 year after embryo transfer cumulative live birth within 6 months of randomization
ongoing pregnancy 12 weeks' gestation a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer
number of euploid blastocysts in an OS cycle 1 month after oocyte retrieval the number of blastocysts acquired in an ovarian stimulation cycle that are identified as euploid by PGT-A
clinical pregnancy rate 6 weeks after embryo transfer the presence of intrauterine gestational sac by transvaginal ultrasound at 6 gestational weeks of the first frozen embryo transfer
the probability of obtaining euploid blastocysts in an OS cycle 1 month after oocyte retrieval 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.
KIDScore of euploid embryos 6 days after oocyte retrieval an AI-driven embryo score generated through the EmbryoViewer software relying on kinetic parameters and associated with embryo implantation potential
Trial Locations
- Locations (1)
Shanghai JIAI Genetics and IVF Institute
🇨🇳Shanghai, Shanghai, China