RecruitingPhase 3NCT05447208

Effect of GH on the Blastocyst Euploid Rate in AMA Patients

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


Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Enrollment

400 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 38 Years

Inclusion Criteria3

  • Age ≥38; intended to undergo PGT-A
  • BMI in the normal range (18.50-24.0kg/m2)
  • Normal semen analysis for the male partner

Exclusion Criteria5

  • 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
  • History of endocrine disorder, autoimmune diseases or diagnosed thrombophilia
  • History of GH supplementation in the previous IVF treatment or taking other supplementary drugs used during stimulation; patients with absolute or relative contraindications to GH treatment, including active malignancy or history of cancer, diabetic retinopathy, diabetes mellitus, and chronic kidney disease.

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Interventions

DRUGGrowth Hormone

Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval

DRUGGnRH antagonist

GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger


Locations(1)

Shanghai JIAI Genetics and IVF Institute

Shanghai, Shanghai Municipality, China

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NCT05447208


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