Infertility, Female Clinical Trial
Official title:
Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation? A Randomized Control Trial.
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.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | July 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | ART Fertility Clinics LLC | Abu Dhabi |
Lead Sponsor | Collaborator |
---|---|
ART Fertility Clinics LLC |
United Arab Emirates,
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, V — View Citation
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. — View Citation
Gurtner GC, Werner S, Barrandon Y, Longaker MT. Wound repair and regeneration. Nature. 2008 May 15;453(7193):314-21. doi: 10.1038/nature07039. — View Citation
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. — View Citation
Lacci KM, Dardik A. Platelet-rich plasma: support for its use in wound healing. Yale J Biol Med. 2010 Mar;83(1):1-9. — View Citation
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. — View Citation
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: 10.1 — View Citation
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. — View Citation
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: 10.1080/095 — View Citation
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 — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical pregnancy by blood test | pregnancy (yes or no) defined by a ßhCG test of > 15IU | 12 weeks | |
Other | Implantation rate (%) | defined by the number of gestational sacs/number of embryos transferred | 4 weeks | |
Other | Clinical pregnancy by ultrasound | defined by the ultrasonographic visualization of one or more gestational sacs, including ectopic pregnancies | 12 weeks | |
Primary | Follicle growth above 4 mm | One or more follicles evaluated by transvaginal ultrasound. Defined by number of follicles growing, quantitative variable. | 1 day | |
Primary | Anti-Müllerian hormone evaluation after intervention. | Anti-Müllerian hormone evaluation after intervention. | 1 day | |
Primary | Follicle-stimulating hormone evaluation after intervention. | Follicle-stimulating hormone evaluation after intervention. | 1 day | |
Primary | Luteinizing hormone evaluation after intervention. | Luteinizing hormone evaluation after intervention. | 1 day | |
Primary | Estradiol hormone evaluation after intervention. | Estradiol hormone evaluation after intervention. | 1 day | |
Primary | Progesterone hormone evaluation after intervention. | Progesterone hormone evaluation after intervention. | 1 day | |
Primary | Spontaneous menstruation. | Spontaneous menstruation. | 1 day | |
Primary | Arteria ovarica doppler results. | Arteria ovarica doppler results. Resistance index. | 1 day | |
Secondary | Number of follicles | Number of follicles | 1 day | |
Secondary | Number of oocytes retrieved | Number of oocytes retrieved | 1 day | |
Secondary | Fertilization rate | percentage of 2PN embryos per oocyte injected | 1 day | |
Secondary | Blastulation rate | percentage of blastocysts per 2PN embryos | 1 day | |
Secondary | Aneuploidy rate | percentage of aneuploid blastocysts per total blastocyst biopsied | 1 day |
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