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

Launched by ART FERTILITY CLINICS LLC · May 14, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring whether a technique called mechanical stimulation can help activate ovarian follicles in women who have premature ovarian failure (POI). POI is a condition that causes the ovaries to stop functioning normally before the age of 40, which can lead to infertility. The trial aims to find new ways to improve ovarian function for women facing this challenge, as current treatments are limited and not very effective.

To participate in this trial, women must be 40 years old or younger and have been diagnosed with primary ovarian insufficiency, showing specific hormone levels and other criteria. Participants will undergo assessments, including an ultrasound, and may have the opportunity to receive further fertility treatments, such as in vitro fertilization (IVF), if there is a positive response to the mechanical stimulation. It's important to note that women with certain genetic conditions, previous cancer treatments, or serious health issues will not be eligible for the study. If you're interested, please discuss this opportunity with your doctor to see if it might be right for you.

Gender

FEMALE

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
• • 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.