Impact of Growth Hormone on Blastocyst Quality in Older Women
A Randomized Control Trial to Investigate the Effect of Growth Hormone on the Euploid Rate of Blastocyst in Patients With Advanced Maternal Age
This study is testing if adding growth hormone to treatment can help older women create healthier embryos when they are trying to get pregnant.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 38 Years and up |
| Sex | Female |
| Sponsor | ShangHai Ji Ai Genetics & IVF Institute Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05447208 on ClinicalTrials.gov |
What this trial studies
This randomized trial investigates the effect of growth hormone (GH) supplementation on the euploid rate of blastocysts in women aged 38 and older undergoing preimplantation genetic testing for aneuploidy (PGT-A). Participants will be randomly assigned to receive either GH during ovarian stimulation or standard treatment without GH. The primary outcome measured will be the rate of euploid blastocysts, which are embryos with the correct number of chromosomes. This study aims to determine if GH can improve embryo quality in older women facing infertility.
Who should consider this trial
Good fit: Ideal candidates are women aged 38 and older who are planning to undergo PGT-A and meet specific health criteria.
Not a fit: Patients with significant uterine abnormalities or those with a history of certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the chances of achieving healthy pregnancies for older women undergoing IVF.
How similar studies have performed: While the use of growth hormone in IVF is being explored, this specific approach in older women undergoing PGT-A is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai JIAI Genetics and IVF Institute — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: XIAOXI SUN, PhD — Shanghai JiAi Genetics & IVF Institute, China
- Study coordinator: Yilun Sui, Md
- Email: 08301010255@fudan.edu.cn
- Phone: 86-13661553127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.