Effect of GH on the Blastocyst Euploid Rate in AMA Patients

February 7, 2025 updated by: ShangHai Ji Ai Genetics & IVF Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: XIAOXI SUN, PHD

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • Shanghai JIAI Genetics and IVF Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 50 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: 1 year after embryo transfer
deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer
1 year after embryo transfer
cumulative live birth rate
Time Frame: 1 year after embryo transfer
cumulative live birth within 6 months of randomization
1 year after embryo transfer
ongoing pregnancy
Time Frame: 12 weeks' gestation
a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer
12 weeks' gestation
clinical pregnancy rate
Time Frame: 6 weeks after embryo transfer
the presence of intrauterine gestational sac by transvaginal ultrasound at 6 gestational weeks of the first frozen embryo transfer
6 weeks after embryo transfer
number of euploid blastocysts in an OS cycle
Time Frame: 1 month after oocyte retrieval
the number of blastocysts acquired in an ovarian stimulation cycle that are identified as euploid by PGT-A
1 month after oocyte retrieval
the probability of obtaining euploid blastocysts in an OS cycle
Time Frame: 1 month after oocyte retrieval
If the ovarian stimulation cycle produces euploid blastocysts, the result is 1; if not, it's 0. Mean values will be calculated for the two groups.
1 month after oocyte retrieval
KIDScore of euploid embryos
Time Frame: 6 days after oocyte retrieval
an AI-driven embryo score generated through the EmbryoViewer software relying on kinetic parameters and associated with embryo implantation potential
6 days after oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Investigators

  • Principal Investigator: XIAOXI SUN, PHD, Shanghai JiAi Genetics & IVF Institute, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 3, 2022

First Submitted That Met QC Criteria

July 3, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022JIAI-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Data will be available when beginning 3 months and ending 5 years following article publication

IPD Sharing Access Criteria

To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with. Proposals should be sent to 08301010255@fudan.edu.cn.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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