RecruitingNCT04390308

Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?

Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation? A Randomized Control Trial.

Sponsor

ART Fertility Clinics LLC

Enrollment

70 participants

Start Date

Jun 2, 2021

Study Type

OBSERVATIONAL

Conditions

Infertility, Female Premature Ovarian Failure IVF

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria11

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 Criteria9

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.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.