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

S

ShangHai Ji Ai Genetics & IVF Institute

Status and phase

Completed
Phase 3

Conditions

Growth Hormone
PGT-A
Advanced Maternal Age

Treatments

Drug: GnRH antagonist
Drug: Growth hormone

Study type

Interventional

Funder types

Other

Identifiers

NCT05574894
JIAI E2022-022

Details and patient eligibility

About

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.

Enrollment

692 patients

Sex

Female

Ages

38 to 46 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

692 participants in 2 patient groups

GH group
Experimental group
Description:
Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation
Treatment:
Drug: Growth hormone
Drug: GnRH antagonist
Control group
Active Comparator group
Description:
No Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation
Treatment:
Drug: GnRH antagonist

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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