Advanced Maternal Age, Growth Hormone, PGT-A
Conditions
Brief summary
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.
Interventions
DRUGGrowth hormone
Growth hormone is supplemented during the ovarian stimulation till the day of trigger
DRUGGnRH antagonist
GnRH antagonist protocol for ovarian stimulation
Sponsors
ShangHai Ji Ai Genetics & IVF Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
38 Years to 46 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of cycles which obtained euploid blastocysts | 1 month after oocyte retrieval | Number of cycles with at least 1 euploid blastocyst divided by the total number of stimulation cycles in a cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Euploid blastocyst rate per cohort | 1 month after oocyte retrieval | Total number of euploid blastocyst in a cohort/total number of biopsied embryos in the same cohort |
| Euploidy rate per cycle | 1 month after oocyte retrieval | Euploidy rate of blastocysts, calculated per stimulation cycle and per testing cycle |
Other
| Measure | Time frame | Description |
|---|---|---|
| Embryo implantation | 14 days after embryo transfer | Positive serum HCG 14 days after embryo transfer. Implantation rate=number of embryos implanted/embryo of embryos tranferred. |
| Clinical pregnancy | 30 days after embryo transfer | Clinical pregnancy is defined as visualization of the gestational sac on ultrasonography. Clinical pregnancy rate=number of ongoing pregnancies/number of embryos transferred. |
| Ongoing pregnancy | 12 weeks' gestation | Ongoing pregnancy is defined as a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer. Ongoing pregnancy rate=number of ongoing pregnancies/number of embryos transferred. |
Countries
China
Outcome results
None listed