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

NCT ID: NCT05574894

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

692 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Growth Hormone Advanced Maternal Age PGT-A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GH group

Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

Group Type EXPERIMENTAL

Growth hormone

Intervention Type DRUG

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

GnRH antagonist

Intervention Type DRUG

GnRH antagonist protocol for ovarian stimulation

Control group

No Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

Group Type ACTIVE_COMPARATOR

GnRH antagonist

Intervention Type DRUG

GnRH antagonist protocol for ovarian stimulation

Interventions

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Growth hormone

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

Intervention Type DRUG

GnRH antagonist

GnRH antagonist protocol for ovarian stimulation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

38 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ShangHai Ji Ai Genetics & IVF Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaoxi Sun, PhD

Role: STUDY_DIRECTOR

Shanghai JIAI Genetics and IVF Institute

Locations

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Shanghai JIAI Genetics and IVF Institute

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 37858247 (View on PubMed)

Other Identifiers

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JIAI E2022-022

Identifier Type: -

Identifier Source: org_study_id

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