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

NCT04390308 | Recruiting DMC

• 1 other identifier: 2004-ABU-005-LM
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female; Premature Ovarian Failure; IVF

Outcome Measures

Primary Outcomes (8)

• Follicle growth above 4 mm

  One or more follicles evaluated by transvaginal ultrasound. Defined by number of follicles growing, quantitative variable.

  1 day

• Anti-Müllerian hormone evaluation after intervention.

  Anti-Müllerian hormone evaluation after intervention.

  1 day

• Follicle-stimulating hormone evaluation after intervention.

  Follicle-stimulating hormone evaluation after intervention.

  1 day

• Luteinizing hormone evaluation after intervention.

  Luteinizing hormone evaluation after intervention.

  1 day

• Estradiol hormone evaluation after intervention.

  Estradiol hormone evaluation after intervention.

  1 day

• Progesterone hormone evaluation after intervention.

  Progesterone hormone evaluation after intervention.

  1 day

• Spontaneous menstruation.

  Spontaneous menstruation.

  1 day

• Arteria ovarica doppler results.

  Arteria ovarica doppler results. Resistance index.

  1 day

Secondary Outcomes (5)

• Number of follicles

  1 day

• Number of oocytes retrieved

  1 day

• Fertilization rate

  1 day

• Blastulation rate

  1 day

• Aneuploidy rate

  1 day

Other Outcomes (3)

• Clinical pregnancy by blood test

  12 weeks

• Implantation rate (%)

  4 weeks

• Clinical pregnancy by ultrasound

  12 weeks

Study Arms (2)

Intervention

The cortex of selected ovary will be punctured up to ten times. In the surgical report, the surgeon will state how many punctures have been done.

Procedure: Ovarian puncture; Other: Hormonal blood Test; Diagnostic Test: Transvaginal ultrasound

Control

No intervention

Interventions

Ovarian puncture PROCEDURE

Egg collection

Intervention

Hormonal blood Test OTHER

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

Intervention

Transvaginal ultrasound DIAGNOSTIC_TEST

Doppler of arteria ovarica. Resistance index

Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Adult women with primary or secondary infertility with a diagnosis of POI, willing to perform an IVF treatment
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adult women with primary or secondary infertility with a diagnosis of POI, willing to perform an IVF treatment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

RECRUITING

Related Publications (11)

• Ford EA, Beckett EL, Roman SD, McLaughlin EA, Sutherland JM. Advances in human primordial follicle activation and premature ovarian insufficiency. Reproduction. 2020 Jan;159(1):R15-R29. doi: 10.1530/REP-19-0201.

  PMID: 31376814 BACKGROUND

• Zhang X, Han T, Yan L, Jiao X, Qin Y, Chen ZJ. Resumption of Ovarian Function After Ovarian Biopsy/Scratch in Patients With Premature Ovarian Insufficiency. Reprod Sci. 2019 Feb;26(2):207-213. doi: 10.1177/1933719118818906. Epub 2018 Dec 12.

  PMID: 30541396 BACKGROUND

• Kawamura K, Kawamura N, Hsueh AJ. Activation of dormant follicles: a new treatment for premature ovarian failure? Curr Opin Obstet Gynecol. 2016 Jun;28(3):217-22. doi: 10.1097/GCO.0000000000000268.

  PMID: 27022685 BACKGROUND

• Nurden AT. Platelets, inflammation and tissue regeneration. Thromb Haemost. 2011 May;105 Suppl 1:S13-33. doi: 10.1160/THS10-11-0720. Epub 2011 Apr 11.

  PMID: 21479340 BACKGROUND

• Gurtner GC, Werner S, Barrandon Y, Longaker MT. Wound repair and regeneration. Nature. 2008 May 15;453(7193):314-21. doi: 10.1038/nature07039.

  PMID: 18480812 BACKGROUND

• Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9.

  PMID: 20351977 BACKGROUND

• Sfakianoudis K, Simopoulou M, Nitsos N, Rapani A, Pantou A, Vaxevanoglou T, Kokkali G, Koutsilieris M, Pantos K. A Case Series on Platelet-Rich Plasma Revolutionary Management of Poor Responder Patients. Gynecol Obstet Invest. 2019;84(1):99-106. doi: 10.1159/000491697. Epub 2018 Aug 22.

  PMID: 30134239 BACKGROUND

• Sills ES, Rickers NS, Li X, Palermo GD. First data on in vitro fertilization and blastocyst formation after intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. Gynecol Endocrinol. 2018 Sep;34(9):756-760. doi: 10.1080/09513590.2018.1445219. Epub 2018 Feb 28.

  PMID: 29486615 BACKGROUND

• Sills ES, Li X, Rickers NS, Wood SH, Palermo GD. Metabolic and neurobehavioral response following intraovarian administration of autologous activated platelet rich plasma: First qualitative data. Neuro Endocrinol Lett. 2019 Jan;39(6):427-433.

  PMID: 30796792 BACKGROUND

• Sills ES, Rickers NS, Svid CS, Rickers JM, Wood SH. Normalized Ploidy Following 20 Consecutive Blastocysts with Chromosomal Error: Healthy 46, XY Pregnancy with IVF after Intraovarian Injection of Autologous Enriched Platelet-derived Growth Factors. Int J Mol Cell Med. 2019 Winter;8(1):84-90. doi: 10.22088/IJMCM.BUMS.8.1.84. Epub 2019 May 15.

  PMID: 32195207 BACKGROUND

• European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI; Webber L, Davies M, Anderson R, Bartlett J, Braat D, Cartwright B, Cifkova R, de Muinck Keizer-Schrama S, Hogervorst E, Janse F, Liao L, Vlaisavljevic V, Zillikens C, Vermeulen N. ESHRE Guideline: management of women with premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):926-37. doi: 10.1093/humrep/dew027. Epub 2016 Mar 22.

  PMID: 27008889 BACKGROUND

Related Links

• Ovarian rejuvenation and folliculogenesis reactivation in peri-menopausal women after autologous platelet-rich plasma treatment

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Infertility, Female; Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Laura Melado, PhD

  ART Fertility Clinics LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

barbara Lawrenz, PhD

CONTACT

+97126528000; jonalyn.edades@artfertilityclinics.com

Jonalyn Edades

CONTACT

+97126528000; jonalyn.edades@artfertilityclinics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 15, 2020
• Study Start: June 2, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-01

Locations

AE (1)