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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04390308
Enrollment
70
Registered
2020-05-15
Start date
2021-06-02
Completion date
2025-12-31
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female, Premature Ovarian Failure, IVF

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.

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 follicles and the mechanisms controlling their selective activation which constitute the committing step into folliculogenesis are essential for determining fertility outcomes in women. While POI is sometimes called premature menopause, it is not identical with menopause. Women with POI may still have occasional irregular periods and may even occasionally achieve a pregnancy. Symptoms of POI include irregular menses or amenorrhea, infertility, hypoestrogenic symptoms and decreased libido. POI may be caused by chromosomal defects such as mosaic Turner's syndrome, exposure to toxins (chemotherapy or radiation), autoimmunity, genetic factors (FMR1) and other unknown factors. Recently, new promising approaches have emerged for infertility treatment in patients with POI, which are based on arousing the still available primordial follicle pool. It is supposed that these techniques activate dormant primordial follicles using a combination of mechanical signaling and biochemical factors. The hypothesis that mild local ovarian injury, such as ovarian puncture, which is a usual procedure in an IVF center with minimal side effects, might exert a similar favorable effect in women with POI arouses our curiosity. Different groups have published case series of ovarian procedures, injecting substances in the ovaries (A-PRP) or ovarian biopsies / scratch in infertile patients with low ovarian reserve (LOR) or/and patients with POF. However, those studies were underpowered, including not enough number of cases, with variable inclusion criteria and reporting results with very low scientific evidence. Furthermore, the mechanical effect of injecting the ovary should be taken into consideration during the evaluation of these patients, yet it might improve the ovarian function as well. There are no previous randomized controlled trials considering a procedure as ovarian puncture, which is easier and accessible at any fertility center.

Interventions

Egg collection

OTHERHormonal blood Test

AMH (ng/ml), FSH (IU/mL), E2(pg/mL), P4(ng/mL), LH (IU/mL)

DIAGNOSTIC_TESTTransvaginal ultrasound

Doppler of arteria ovarica. Resistance index

Sponsors

ART Fertility Clinics LLC
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Arteria ovarica doppler results.1 dayArteria ovarica doppler results. Resistance index.
Follicle growth above 4 mm1 dayOne or more follicles evaluated by transvaginal ultrasound. Defined by number of follicles growing, quantitative variable.
Anti-Müllerian hormone evaluation after intervention.1 dayAnti-Müllerian hormone evaluation after intervention.
Follicle-stimulating hormone evaluation after intervention.1 dayFollicle-stimulating hormone evaluation after intervention.
Luteinizing hormone evaluation after intervention.1 dayLuteinizing hormone evaluation after intervention.
Estradiol hormone evaluation after intervention.1 dayEstradiol hormone evaluation after intervention.
Progesterone hormone evaluation after intervention.1 dayProgesterone hormone evaluation after intervention.
Spontaneous menstruation.1 daySpontaneous menstruation.

Secondary

MeasureTime frameDescription
Aneuploidy rate1 daypercentage of aneuploid blastocysts per total blastocyst biopsied
Number of oocytes retrieved1 dayNumber of oocytes retrieved
Fertilization rate1 daypercentage of 2PN embryos per oocyte injected
Blastulation rate1 daypercentage of blastocysts per 2PN embryos
Number of follicles1 dayNumber of follicles

Other

MeasureTime frameDescription
Clinical pregnancy by blood test12 weekspregnancy (yes or no) defined by a βhCG test of \> 15IU
Implantation rate (%)4 weeksdefined by the number of gestational sacs/number of embryos transferred
Clinical pregnancy by ultrasound12 weeksdefined by the ultrasonographic visualization of one or more gestational sacs, including ectopic pregnancies

Countries

United Arab Emirates

Contacts

Primary Contactbarbara Lawrenz, PhD
jonalyn.edades@artfertilityclinics.com+97126528000
Backup ContactJonalyn Edades
jonalyn.edades@artfertilityclinics.com+97126528000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026