Exploring Mechanical Stimulation for Ovarian Follicle Activation
Official title: Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation? A Randomized Control Trial.
Run by ART Fertility Clinics LLC · NCT04390308 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 70 (estimated) |
| Sponsor | ART Fertility Clinics LLC Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Abu Dhabi, Abu Dhabi Emirate) |
| Status | Recruiting |
| Started | June 2, 2021 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | February 19, 2025 |
| Trial ID | NCT04390308 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 40 and younger with documented primary ovarian insufficiency and specific hormonal profiles.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.