Effect of GH on the Blastocyst Euploid Rate in AMA Patients

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05574894

Growth Hormone Advanced Maternal Age PGT-A

COMPLETED PHASE3

Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Patients Undergoing PGT-A

NCT04414748

Preimplantation Genetic Testing Progestin-primed Ovarian Stimulation Euploid Rate +1 more

COMPLETED PHASE3

Euploid Rate of Blastocyst Derived From PPOS VS Antagonist Protocol

NCT04989348

IVF

COMPLETED NA

Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A

NCT05326087

Preimplantation Genetic Testing Progestin-primed Ovarian Stimulation Polycystic Ovarian Syndrome +1 more

NOT_YET_RECRUITING PHASE3

Growth Hormone Adding to Controlled Ovarian Hyperstimulation for Improving Embryo Quality

NCT03966339

Infertility,Female

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preimplantation Genetic Testing Growth Hormone Age, Parental

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The embryologists, genetic scientists, and the independent statistician will be blinded to the group allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group

GH is supplemented during ovarian stimulation

Group Type EXPERIMENTAL

Growth Hormone

Intervention Type DRUG

Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval

GnRH antagonist

Intervention Type DRUG

GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger

Control group

GH is not supplemented during ovarian stimulation.

Group Type ACTIVE_COMPARATOR

GnRH antagonist

Intervention Type DRUG

GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Growth Hormone

Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval

Intervention Type DRUG

GnRH antagonist

GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No