Age, Parental, Growth Hormone, Preimplantation Genetic Testing
Conditions
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.
Interventions
DRUGGrowth Hormone
Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval
DRUGGnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
Sponsors
ShangHai Ji Ai Genetics & IVF Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The embryologists, genetic scientists, and the independent statistician will be blinded to the group allocation.
Eligibility
Sex/Gender
FEMALE
Age
38 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| euploidy rate | 1 month after oocyte retrieval | euploidy rate of blastocysts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| live birth rate | 1 year after embryo transfer | deliveries ≥22 weeks gestation with heartbeat and breath 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 |
| 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 |
Countries
China
Contacts
Primary ContactYILUN SUI, MD
Backup ContactXIAOXI SUN, PhD
Outcome results
None listed