Investigating DHEA for improving IVF outcomes in women with poor ovarian response
Effect of Dehydroepiandrosterone on Live Birth Rate in Subfertile Patients With Poor Ovarian Responds
This study is testing if taking a hormone called DHEA can help women with poor ovarian response have more successful pregnancies through IVF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 21 Years to 42 Years |
| Sex | Female |
| Sponsor | The Affiliated Hospital of Inner Mongolia Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Inner Mongolia) |
| Trial ID | NCT02432248 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effect of Dehydroepiandrosterone (DHEA) on live birth rates among subfertile women identified as poor ovarian responders. Participants will be randomly assigned to receive either DHEA or a placebo for 12 weeks prior to undergoing in vitro fertilization (IVF). Baseline assessments will include hormonal evaluations and ultrasound scans to determine ovarian reserve. The outcomes will be measured by comparing the number of live births between the two groups after IVF treatment.
Who should consider this trial
Good fit: Ideal candidates are women under 42 years old with regular menstrual cycles and classified as poor ovarian responders.
Not a fit: Patients with conditions such as polycystic ovarian syndrome or those who have undergone previous chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance the chances of live birth for women with poor ovarian reserve undergoing IVF.
How similar studies have performed: Previous studies have shown promising results with DHEA supplementation in improving IVF outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indicated for IVF treatment according to our standard department protocol * Age \< 42 * Regular menstrual cycles (21-35 days) Poor ovarian responders are defined according to the Bologna criteria fulfilling 2 out of 3 of the following: * Advanced maternal age (≥40) or any other genetic or acquired risk factor for POR * Previous poor ovarian response (POR) (≤3 oocytes with a conventional stimulation protocol using at least 150IU gonadotrophins per day) * Abnormal ovarian reserve test (i.e. AFC \< 5-7 or AMH \< 0.5-1.1ng/ml). Alternatively, two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT. Exclusion Criteria: * Previous chemotherapy or pelvic irradiation * Polycystic ovarian syndrome or polycystic ovaries * On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)
Where this trial is running
Inner Mongolia
- The Affiliated Hospital of Inner Mongolia Medical University — Inner Mongolia, China (Recruiting)
Study contacts
- Principal investigator: Yu Wang, PHD — The Affiliated Hospital of Inner Mongolia Medical University
- Study coordinator: Yu Wang, PHD
- Email: wuai1544@163.com
- Phone: 86-18604718958
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.