NCT04390308 Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?
| NCT ID | NCT04390308 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ART Fertility Clinics LLC |
| Condition | Infertility, Female |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-06-02 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2021-06-02 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Premature ovarian failure (POI) is a loss of normal function before age 40, leading to infertility and hypoestrogenism. About 1% of women younger than 40 years old and 0.1% before 30 are affected. Most patients already had impaired or complete loss of fecundity when diagnosed. Hence, the treatment of POI is particularly tough. Currently, no optimal regimen exists to ameliorate ovarian function.
Eligibility 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.
Contact & Investigator
Laura Melado, PhD
PRINCIPAL INVESTIGATOR
ART Fertility Clinics LLC
Frequently Asked Questions
Who can join the NCT04390308 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Infertility, Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04390308 currently recruiting?
Yes, NCT04390308 is actively recruiting participants. Contact the research team at jonalyn.edades@artfertilityclinics.com for enrollment information.
Where is the NCT04390308 trial being conducted?
This trial is being conducted at Abu Dhabi, United Arab Emirates.
Who is sponsoring the NCT04390308 clinical trial?
NCT04390308 is sponsored by ART Fertility Clinics LLC. The principal investigator is Laura Melado, PhD at ART Fertility Clinics LLC. The trial plans to enroll 70 participants.