RecruitingPhase 3

Effect of GH on the Blastocyst Euploid Rate in AMA Patients

China400 participantsStarted 2022-08-01

Plain-language summary

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.

Who can participate

Age range

38 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

euploidy rate

Timeframe: 1 month after oocyte retrieval

Trial details

NCT IDNCT05447208

SponsorShangHai Ji Ai Genetics & IVF Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

Contact for this trial

YILUN SUI, MD

86-13661553127 08301010255@fudan.edu.cn

View on ClinicalTrials.gov More Preimplantation Genetic Testing trials