Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorART Fertility Clinics LLC
About this trial
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
This trial does not accept healthy volunteersQualifiers
Signed and dated informed consent
Women 40 years of age and younger with documented primary ovarian insufficiency (12).
Normal Karyotype
BMI </= 35 kg/m2
Disqualifiers
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.
Trial population
Adult women with primary or secondary infertility with a diagnosis of POI, willing to perform an IVF treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ovarian puncture
Procedure/SurgeryEgg collection
Hormonal blood Test
Other interventionAMH (ng/ml), FSH (IU/mL), E2(pg/mL), P4(ng/mL), LH (IU/mL)
Transvaginal ultrasound
Diagnostic testDoppler of arteria ovarica. Resistance index
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Intervention3 interventions
Group B: Control0 interventions
Trial outcomes
Primary outcomes
1
Follicle growth above 4 mm
One or more follicles evaluated by transvaginal ultrasound. Defined by number of follicles growing, quantitative variable.
Time frame
1 day2
Anti-Müllerian hormone evaluation after intervention.
Anti-Müllerian hormone evaluation after intervention.
Time frame
1 day3
Follicle-stimulating hormone evaluation after intervention.
Follicle-stimulating hormone evaluation after intervention.
Time frame
1 day4
Luteinizing hormone evaluation after intervention.
Luteinizing hormone evaluation after intervention.
Time frame
1 daySecondary outcomes
1
Number of follicles
Number of follicles
Time frame
1 day2
Number of oocytes retrieved
Number of oocytes retrieved
Time frame
1 day3
Fertilization rate
percentage of 2PN embryos per oocyte injected
Time frame
1 day4
Blastulation rate
percentage of blastocysts per 2PN embryos
Time frame
1 dayOther outcomes
1
Clinical pregnancy by blood test
pregnancy (yes or no) defined by a βhCG test of \> 15IU
Time frame
12 weeks2
Implantation rate (%)
defined by the number of gestational sacs/number of embryos transferred
Time frame
4 weeks3
Clinical pregnancy by ultrasound
defined by the ultrasonographic visualization of one or more gestational sacs, including ectopic pregnancies
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov