Single-injection ovarian stimulation for infertility treatment
One-Shot Ovarian Stimulation Protocol: A Pilot Study Investigating the Endocrine Profile
This study is testing a new one-time injection treatment for women under 40 with infertility to see if it can make the ovarian stimulation process easier and more effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Fundacion Dexeus Academic / other |
| Locations | 3 sites (Sabadell, Barcelona and 2 other locations) |
| Trial ID | NCT06635538 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the endocrine profile of a novel one-shot ovarian stimulation protocol using a single injection of corifollitropin alfa (CFA) combined with daily oral administration of clomiphene citrate (CC). The approach aims to simplify the ovarian stimulation process for women experiencing infertility. Participants will be monitored throughout their cycle to assess the effectiveness of this treatment regimen. The study focuses on women under 40 with specific hormonal and reproductive health criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 40 and under with specific hormonal profiles and no significant family history of genetic disorders.
Not a fit: Patients with a BMI outside the range of 18 to 30 kg/m2 or those with a family history of hereditary or chromosomal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more efficient and less invasive option for women struggling with infertility.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in simplifying ovarian stimulation protocols, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age \<= 40 AMH (Anti-Mullerian Hormone) 1.2-3.5 ng/ml or AFC 7-20 No family history of hereditary or chromosomal diseases Body mass index (BMI) 18 to 30 kg/m2
Where this trial is running
Sabadell, Barcelona and 2 other locations
- Dexeus Mujer Sabadell — Sabadell, Barcelona, Spain (Recruiting)
- Dexeus Mujer Sant Cugat — Sant Cugat del Vallès, Barcelona, Spain (Recruiting)
- Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus — Barcelona, Spain (Not_yet_recruiting)
Study contacts
- Principal investigator: Nikolaos P Polyzos, MD, PhD — Dexeus Fertility
- Study coordinator: Nikolaos P Polyzos, MD, PhD
- Email: nikpol@dexeus.com
- Phone: 0034932274700
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.