Effect of GH on the Blastocyst Euploid Rate in AMA Patients

Study Overview
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Brief Summary
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This randomized trial aims to compare the euploid rate of blastocysts in AMA patients undergoing PGT-A (preimplantation genetic testing for aneuploidy) with or without growth hormone supplement. Infertile patients ≥38 years old will be recruited for study after informed consent if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups: Treatment group: Women will receive growth hormone (GH) supplement before and during antagonist protocol for ovarian stimulation. Control group: Women will receive antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts.

Official Title
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A Randomized Control Trial to Investigate the Effect of Growth Hormone on the Euploid Rate of Blastocyst in Patients With Advanced Maternal Age

Conditions
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Preimplantation Genetic Testing, Growth Hormone, Age, Parental

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; intended to undergo PGT-A 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;

Ages Eligible for Study
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Minimum Age: 38 Years
Maximum Age: 50 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>GH is supplemented during ovarian stimulation | Drug: Growth Hormone<br>* Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval<br>Drug: GnRH antagonist<br>* GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger<br>|
| Active Comparator: Control group<br>GH is not supplemented during ovarian stimulation. | Drug: GnRH antagonist<br>* GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| euploidy rate | euploidy rate of blastocysts | 1 month after oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer | 1 year after embryo transfer | 
| cumulative live birth rate | cumulative live birth within 6 months of randomization | 1 year after embryo transfer | 
| ongoing pregnancy | a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer | 12 weeks' gestation |