Clinical trial Recruiting at 1 site Observational Ages 18 to 40 Women only

Exploring Mechanical Stimulation for Ovarian Follicle Activation

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

Run by ART Fertility Clinics LLC · NCT04390308 · Data updated 2026-11-12

This study is testing if a procedure that gently stimulates the ovaries can help women under 40 with premature ovarian failure activate dormant eggs and improve their chances of getting pregnant.

Quick facts

Study typeObservational
Ages18 Years to 40 Years
SexWomen only
Enrollment70 (estimated)
SponsorART Fertility Clinics LLC
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Abu Dhabi, Abu Dhabi Emirate)
StatusRecruiting
StartedJune 2, 2021
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedFebruary 19, 2025
Trial IDNCT04390308 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are women aged 40 and younger with documented primary ovarian insufficiency and specific hormonal profiles.

Probably not a fit

Patients with premature ovarian failure due to genetic origins or those with oncological or autoimmune diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the potential role of mechanical stimulation, specifically ovarian puncture, in activating dormant ovarian follicles in women with premature ovarian failure (POI). The study aims to understand how this technique, combined with hormonal assessments and transvaginal ultrasound, may improve fertility outcomes for women under 40 who have documented primary ovarian insufficiency. By examining the effects of mild local ovarian injury, the researchers hope to identify new approaches to enhance ovarian function and fertility in this challenging patient population.

Why it matters

Potential benefit: If successful, this approach could provide new fertility options for women suffering from premature ovarian failure.

How similar studies have gone: While similar approaches have been explored, this specific method of mechanical stimulation for follicle activation in POI is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • ART Fertility Clinics LLC
    Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.