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NCT Number: NCT05574894

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

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.

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Key information

Conditions

Growth Hormone Advanced Maternal Age PGT-A

Age range

38 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai JIAI Genetics and IVF Institute

Shanghai, Shanghai Municipality, 200011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

growth hormone

Drug

Growth hormone is supplemented during the ovarian stimulation till the day of trigger

GnRh antagonist

Drug

GnRH antagonist protocol for ovarian stimulation

Primary outcomes

  1. Proportion of cycles which obtained euploid blastocysts

    Time frame: 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 outcomes

  1. Euploid blastocyst rate per cohort

    Time frame: 1 month after oocyte retrieval

    Total number of euploid blastocyst in a cohort/total number of biopsied embryos in the same cohort

  2. Euploidy rate per cycle

    Time frame: 1 month after oocyte retrieval

    Euploidy rate of blastocysts, calculated per stimulation cycle and per testing cycle

Other outcomes

  1. Embryo implantation

    Time frame: 14 days after embryo transfer

    Positive serum HCG 14 days after embryo transfer. Implantation rate=number of embryos implanted/embryo of embryos tranferred.

  2. Clinical pregnancy

    Time frame: 30 days after embryo transfer

    Clinical pregnancy is defined as visualization of the gestational sac on ultrasonography. Clinical pregnancy rate=number of ongoing pregnancies/number of embryos transferred.

  3. Ongoing pregnancy

    Time frame: 12 weeks' gestation

    Ongoing pregnancy is defined as a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer. Ongoing pregnancy rate=number of ongoing pregnancies/number of embryos transferred.

Sponsors and collaborators

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2022
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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