Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?
Recruiting
Observational Study
Infertility, FemalePremature Ovarian FailureIVF
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 40
Sex
Female
Study type
Observational
Participants needed
70 (estimated)
Sponsor
ART Fertility Clinics LLC · Other
Who this trial is looking for
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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.
Trial Locations
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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
* …
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.
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