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

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.

Study Overview

• Status: Completed
• Conditions: Growth Hormone; Advanced Maternal Age; PGT-A
• Intervention / Treatment: Drug: Growth hormone; Drug: GnRH antagonist

• Study Type: Interventional
• Enrollment (Actual): 692
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai JiAi Genetics and IVF Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GH group; Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation	Drug: Growth hormone; Growth hormone is supplemented during the ovarian stimulation till the day of trigger; Drug: GnRH antagonist; GnRH antagonist protocol for ovarian stimulation
Active Comparator: Control group; No Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation	Drug: GnRH antagonist; GnRH antagonist protocol for ovarian stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Euploidy rate per cycle	Euploidy rate of blastocysts, calculated per stimulation cycle and per testing cycle	1 month after oocyte retrieval

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: ShangHai Ji Ai Genetics & IVF Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 8, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: JIAI E2022-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No