Status:
RECRUITING
Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?
Lead Sponsor:
ART Fertility Clinics LLC
Conditions:
Infertility, Female
Premature Ovarian Failure
Eligibility:
FEMALE
18-40 years
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. Mos...
Detailed Description
In women, the non-growing population of follicles that comprise the ovarian reserve is determined at birth and serves as the reservoir for future fertility. This reserve of dormant, primordial follicl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 2 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04390308
Start Date
June 2 2021
End Date
December 31 2025
Last Update
February 19 2025
Active Locations (1)
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1
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates, 60202