NCT05574894

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
692

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
Last Updated

February 21, 2023

Status Verified

October 1, 2022

Enrollment Period

1.5 years

First QC Date

October 3, 2022

Last Update Submit

February 16, 2023

Conditions

Growth HormoneAdvanced Maternal AgePGT-A

Outcome Measures

Primary Outcomes (1)

  • Proportion of cycles which obtained euploid blastocysts

    Number of cycles with at least 1 euploid blastocyst divided by the total number of stimulation cycles in a cohort

    1 month after oocyte retrieval

Secondary Outcomes (2)

  • Euploid blastocyst rate per cohort

    1 month after oocyte retrieval

  • Euploidy rate per cycle

    1 month after oocyte retrieval

Other Outcomes (3)

  • Embryo implantation

    14 days after embryo transfer

  • Clinical pregnancy

    30 days after embryo transfer

  • Ongoing pregnancy

    12 weeks' gestation

Study Arms (2)

GH group

EXPERIMENTAL

Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

Drug: Growth hormoneDrug: GnRH antagonist

Control group

ACTIVE COMPARATOR

No Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

Drug: GnRH antagonist

Interventions

Growth hormoneDRUG

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

GH group
GnRH antagonistDRUG

GnRH antagonist protocol for ovarian stimulation

Control groupGH group

Eligibility Criteria

Age38 Years - 46 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai JIAI Genetics and IVF Institute

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

  • Sui Y, Xiao M, Fu J, Li L, Xu Y, Lei C, Sun X. Growth hormone supplementation during ovarian stimulation in women with advanced maternal age undergoing preimplantation genetic testing for Aneuploidy. J Ovarian Res. 2023 Oct 19;16(1):204. doi: 10.1186/s13048-023-01279-y.

    PMID: 37858247DERIVED

MeSH Terms

Interventions

Growth HormoneLHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Xiaoxi Sun, PhD

    Shanghai JIAI Genetics and IVF Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 12, 2022

Study Start

January 1, 2021

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

February 21, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)