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

Phase 3

Completed

• Conditions: Advanced Maternal Age; PGT-A; Growth Hormone
• Interventions: Drug: Growth hormone; Drug: GnRH antagonist

• Registration Number: NCT05574894
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-08
• Study First Posted: 2022-10-12
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 692

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GH group	GnRH antagonist	Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation
Control group	GnRH antagonist	No Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation
GH group	Growth hormone	Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Euploidy rate per cycle	1 month after oocyte retrieval	Euploidy rate of blastocysts, calculated per stimulation cycle and per testing cycle
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

Trial Locations

Locations (1)

Shanghai JIAI Genetics and IVF Institute; 🇨🇳 Shanghai, Shanghai, China