Growth Hormone Clinical Trial
Official title:
Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study
Verified date | October 2022 |
Source | ShangHai Ji Ai Genetics & IVF Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 692 |
Est. completion date | September 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 38 Years to 46 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai JIAI Genetics and IVF Institute | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
ShangHai Ji Ai Genetics & IVF Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Embryo implantation | Positive serum HCG 14 days after embryo transfer. Implantation rate=number of embryos implanted/embryo of embryos tranferred. | 14 days after embryo transfer | |
Other | Clinical pregnancy | Clinical pregnancy is defined as visualization of the gestational sac on ultrasonography. Clinical pregnancy rate=number of ongoing pregnancies/number of embryos transferred. | 30 days after embryo transfer | |
Other | Ongoing pregnancy | 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. | 12 weeks' gestation | |
Primary | Proportion of cycles which obtained euploid blastocysts | Number of cycles with at least 1 euploid blastocyst divided by the total number of stimulation cycles in a cohort | 1 month after oocyte retrieval | |
Secondary | Euploid blastocyst rate per cohort | Total number of euploid blastocyst in a cohort/total number of biopsied embryos in the same cohort | 1 month after oocyte retrieval | |
Secondary | Euploidy rate per cycle | Euploidy rate of blastocysts, calculated per stimulation cycle and per testing cycle | 1 month after oocyte retrieval |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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