Actively Recruiting

Phase 3
Age: 38Years +
FEMALE
ID05447208

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

Led by ShangHai Ji Ai Genetics & IVF Institute · Updated on 2025-02-12

400

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the impact of growth hormone supplementation on the euploidy rate of blastocysts in women with advanced maternal age (38 years and older) undergoing preimplantation genetic testing for aneuploidy (PGT-A). The trial is a randomized control study focused on infertile women, seeking to improve outcomes related to embryo quality during in vitro fertilization. The study is sponsored by ShangHai Ji Ai Genetics & IVF Institute and is conducted as a Phase 3 clinical trial. Participants are randomly assigned to one of two groups: a treatment group that receives growth hormone supplements before and during ovarian stimulation using an antagonist protocol, and a control group that undergoes only the antagonist protocol without growth hormone. Growth hormone is given until the day of oocyte retrieval, while the antagonist drug (Cetrorelix) is administered daily from day 6 of stimulation until ovulation trigger. This setup allows comparison of the blastocyst euploidy rate between these two approaches. During the study, researchers monitor the euploidy rate of blastocysts one month after oocyte retrieval as the primary outcome. Secondary outcomes include live birth rates, ongoing pregnancy status, clinical pregnancy rates, and quality scoring of embryos. Participants undergo ovarian stimulation, embryo testing, and follow-up visits over the course of up to one year after embryo transfer to collect outcome data and assess safety. The total involvement duration varies but includes key assessments at 1 month and 1 year after treatment milestones.

CONDITIONS

Brief Title

Effect of GH on the Blastocyst Euploid Rate in AMA Patients

Who Can Participate

Age: 38Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 38 years or older and intended to undergo PGT-A
  • Body mass index (BMI) in the normal range (18.50-24.0 kg/m2)
  • Normal semen analysis for the male partner
Not Eligible

You will not qualify if you...

  • Endometriosis grade 3 or higher or untreated hydrosalpinx
  • Uterine cavity abnormalities such as congenital malformations, untreated uterine septum, adenomyosis, submucous myoma, or endometrial polyp(s)
  • Planned for PGT-SR or PGT-M due to parental abnormal karyotype or monogenic diseases
  • History of endocrine disorders, autoimmune diseases, or diagnosed thrombophilia
  • Previous growth hormone supplementation during IVF or use of other supplements during stimulation
  • Contraindications to growth hormone including active malignancy, history of cancer, diabetic retinopathy, diabetes mellitus, or chronic kidney disease

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From start of ovarian stimulation until day of oocyte retrieval (approximately 10 to 14 days)

Participants receive growth hormone supplementation and GnRH antagonist during ovarian stimulation until the day of oocyte retrieval, or receive standard care without growth hormone.

Daily visits or injections during ovarian stimulation until oocyte retrieval

Follow-up

Duration - Up to 1 year after embryo transfer

Participants are monitored for outcomes including blastocyst euploidy rate, pregnancy progress, and live birth over up to 1 year after embryo transfer.

Visits at 6 days, 6 weeks, 12 weeks, 1 month, and up to 1 year after embryo transfer

Trial Site Locations

Total: 1 location

1

Shanghai JIAI Genetics and IVF Institute

Shanghai, Shanghai Municipality, China, 200011

Actively Recruiting

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Research Team

Y

YILUN SUI, MD

X

XIAOXI SUN, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Effects of maternal age on euploidy rates in a large cohort of embryos analyzed with 24-chromosome single-nucleotide polymorphism-based preimplantation genetic screening.

Zachary P Demko, Alexander L Simon, Rajiv C McCoy...

https://pubmed.ncbi.nlm.nih.gov/26868992

Growth hormone alleviates oxidative stress and improves oocyte quality in Chinese women with polycystic ovary syndrome: a randomized controlled trial.

Yan Gong, Shan Luo, Ping Fan...

https://pubmed.ncbi.nlm.nih.gov/33127971

Growth hormone ameliorates the age-associated depletion of ovarian reserve and decline of oocyte quality via inhibiting the activation of Fos and Jun signaling.

Chuanming Liu, Shiyuan Li, Yifan Li...

https://pubmed.ncbi.nlm.nih.gov/33621201

Growth hormone supplementation during ovarian stimulation improves oocyte and embryo outcomes in IVF/PGT-A cycles of women who are not poor responders.

Amanda Skillern, Whitney Leonard, Jordyn Pike...

https://pubmed.ncbi.nlm.nih.gov/33534048

Growth hormone during in vitro fertilization in older women modulates the density of receptors in granulosa cells, with improved pregnancy outcomes.

Sheena L P Regan, Phil G Knight, John L Yovich...

https://pubmed.ncbi.nlm.nih.gov/30503129