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

Study Overview
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Brief Summary
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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.

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

Conditions
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Growth Hormone, Advanced Maternal Age, PGT-A

Intervention / Treatment
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* Drug: Growth hormone
* Drug: GnRH antagonist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 38 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |