Using growth hormone to enhance fertility outcomes in young women with low ovarian reserve
A Randomized Controlled Trial of Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve
This study is testing if giving growth hormone to young women with low ovarian reserve can improve their chances of success with fertility treatments like IVF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years to 34 Years |
| Sex | Female |
| Sponsor | Nanjing University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05585177 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of growth hormone on improving clinical outcomes for young patients under 35 years old who have decreased ovarian reserve and are undergoing assisted reproductive techniques like IVF/ICSI. Participants are randomly assigned to either receive growth hormone treatment for three months prior to their fertility procedures or to proceed directly with IVF/ICSI without the hormone. The study aims to determine if the addition of growth hormone can enhance the success rates of these fertility treatments.
Who should consider this trial
Good fit: Ideal candidates are women under 35 years old with specific hormonal markers indicating decreased ovarian reserve.
Not a fit: Patients with severe male infertility factors or significant reproductive health issues such as severe endometriosis or adenomyosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve fertility outcomes for young women facing challenges due to low ovarian reserve.
How similar studies have performed: While the use of growth hormone in fertility treatments is being explored, this specific approach in young patients with low ovarian reserve is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \< 35 years; 2. AFC≤5 3. Follicle stimulating hormone \> 10miu/ml; 4. Anti-mullerian hormone \< 1.1μg/L (2 out of 2-4 items can be met) Exclusion Criteria: 1. Severe male factors: spermatozoa collected by testicular sperm aspiration (TESA) or percutaneous epididymal sperm aspiration (PESA) was used for intracytoplasmic sperm injection (ICSI) cycle of single spermatozoa; 2. Patients with severe adenomyosis, endometriosis, intrauterine adhesions and other diseases that significantly affect embryo implantation; 3. Diabetes mellitus, insulin resistance; 4. chromosomal karyotype abnormality in either spouse; 5. Any pregnancy or contraindications of assisted reproductive technology;
Where this trial is running
Nanjing, Jiangsu
- Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Qingqing Shi, PHD
- Email: qqshnju@sina.com
- Phone: 025-83106666
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.