Exploring Mechanical Stimulation for Ovarian Follicle Activation
Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation? A Randomized Control Trial.
ART Fertility Clinics LLC · NCT04390308
This study is testing if a procedure that gently stimulates the ovaries can help women under 40 with premature ovarian failure activate dormant eggs and improve their chances of getting pregnant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | ART Fertility Clinics LLC (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Abu Dhabi, Abu Dhabi Emirate) |
| Trial ID | NCT04390308 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the potential role of mechanical stimulation, specifically ovarian puncture, in activating dormant ovarian follicles in women with premature ovarian failure (POI). The study aims to understand how this technique, combined with hormonal assessments and transvaginal ultrasound, may improve fertility outcomes for women under 40 who have documented primary ovarian insufficiency. By examining the effects of mild local ovarian injury, the researchers hope to identify new approaches to enhance ovarian function and fertility in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 40 and younger with documented primary ovarian insufficiency and specific hormonal profiles.
Not a fit: Patients with premature ovarian failure due to genetic origins or those with oncological or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide new fertility options for women suffering from premature ovarian failure.
How similar studies have performed: While similar approaches have been explored, this specific method of mechanical stimulation for follicle activation in POI is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed and dated informed consent * Women 40 years of age and younger with documented primary ovarian insufficiency (12). * Normal Karyotype * BMI \</= 35 kg/m2 * Oligo/amenorrhea for at least 4 months * FSH \> 25 IU/mL * AMH \</= 0,1 ng/ml * No evidence of follicles \> 4mm * Must have two ovaries of approximately equal volume. * Willingness to undergo further fertility treatment, including IVF if there is evidence of response * A transvaginal scan including Doppler for arteria ovarica will be performed previously to the surgical procedure. Exclusion Criteria: * Premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality. * Oncological diseases (specially, skeletal system and blood). * Autoimmune diseases, for example, lupus erythematosus, etc. * Previous treatments including radiotherapy or chemotherapy. * Other conditions not suitable for surgical procedures and/or anesthesia. * Anticoagulant or antiaggregant treatment. * Acute and chronic infectious diseases. * Active substance abuse or dependence. * Major Mental health disorder.
Where this trial is running
Abu Dhabi, Abu Dhabi Emirate
- ART Fertility Clinics LLC — Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates (RECRUITING)
Study contacts
- Principal investigator: Laura Melado, PhD — ART Fertility Clinics LLC
- Study coordinator: barbara Lawrenz, PhD
- Email: jonalyn.edades@artfertilityclinics.com
- Phone: +97126528000
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.
Conditions: Infertility, Female, Premature Ovarian Failure, IVF