Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study

Growth Hormone Clinical Trial

Official title:

Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05574894
• Other study ID #: JIAI E2022-022
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Growth Hormone

Intervention

Drug:
• Growth hormone
Growth hormone is supplemented during the ovarian stimulation till the day of trigger
• GnRH antagonist
GnRH antagonist protocol for ovarian stimulation

Locations

Country	Name	City	State
China	Shanghai JIAI Genetics and IVF Institute	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

Outcome

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