What is this study trying to find out about premature ovarian failure?

This study is exploring whether mechanical stimulation of the ovary, specifically ovarian puncture, can activate dormant follicles to improve ovarian function in women with premature ovarian failure. The goal is to better understand how this procedure might help fertility. The research is sponsored by ART Fertility Clinics LLC and aims to provide new treatment options for affected women.

Who may be eligible for this premature ovarian failure clinical trial?

Women 18 to 40 years old with diagnosed primary ovarian insufficiency, normal chromosomes, and irregular or absent periods for at least 4 months may be eligible. Participants must have a BMI of 35 or less and no evidence of follicles larger than 4 mm in both ovaries. Please review eligibility criteria for more details.

Is there any cost to participate in this premature ovarian failure clinical trial?

Study-related care, including the ovarian puncture procedure, hormone tests, ultrasounds, and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for any costs related to travel or accommodations.

Actively Recruiting

Age: 18Years - 40Years

FEMALE

ID04390308

Mechanical Stimulation for Activating Ovarian Follicles in Women with Premature Ovarian Failure A Randomized Controlled Trial

Led by ART Fertility Clinics LLC · Updated on 2025-02-19

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Premature ovarian failure POI causes loss of normal ovarian function before the age of 40, leading to infertility and low estrogen levels. It affects about 1% of women under 40 and has limited treatment options. Researchers are exploring new ways to activate dormant ovarian follicles to improve fertility in women with POI, as current treatments are not optimal. This trial investigates whether mechanical stimulation, such as ovarian puncture, can help activate these follicles and improve ovarian function. The trial compares two groups one undergoing ovarian puncture where the ovarys cortex is punctured up to ten times, and a control group with no intervention. The procedure is common in IVF centers and involves minimal side effects. Researchers will also perform hormonal blood tests and transvaginal ultrasounds with Doppler to assess ovarian blood flow and follicle development. Participants will be closely monitored with various evaluations including follicle growth, hormone levels AMH, FSH, LH, estradiol, progesterone, spontaneous menstruation, and ovarian blood flow via Doppler. Secondary outcomes include the number of follicles and oocytes retrieved, fertilization and blastulation rates, and genetic abnormalities in embryos. The study involves screening, intervention or control period, and follow-up assessments to measure ovarian response and fertility indicators.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years

FEMALE

Eligibility Criteria

You may qualify if you...

Signed and dated informed consent
Women 40 years of age and younger with documented primary ovarian insufficiency
Normal karyotype
BMI 35 kg/m2 or less
Oligo/amenorrhea for at least 4 months
FSH greater than 25 IU/mL
AMH 0.1 ng/ml or less
No evidence of follicles larger than 4 mm
Must have two ovaries of approximately equal volume
Willingness to undergo further fertility treatment including IVF if there is evidence of response
Able to have a transvaginal scan including Doppler for ovarian artery before the procedure

You will not qualify if you...

Premature ovarian failure due to genetic origin such as Turner's Syndrome or chromosomal abnormalities
Oncological diseases especially affecting skeletal system and blood
Autoimmune diseases such as lupus erythematosus
Previous treatments including radiotherapy or chemotherapy
Conditions unsuitable for surgery or anesthesia
Use of anticoagulant or antiaggregant medications
Acute or chronic infectious diseases
Active substance abuse or dependence
Major mental health disorders

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Ovarian puncture

Duration - 1 day

Participants undergo an ovarian puncture procedure where the cortex of the selected ovary is punctured up to ten times to evaluate its effect on ovarian follicular activation.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants receive hormonal blood tests and transvaginal ultrasounds including Doppler of the ovarian artery to assess follicle growth and hormone levels after the ovarian puncture.

1 visit (in-person)