Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608695
Status:
UNKNOWN
Last Update Posted:
2022-09-21
First Post:
2020-10-25
Brief Title:
Ovarian Needle Puncture for Follicle Activation in IVF Patients With Diminished Ovarian Reserve
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Ovarian Needle Puncture for Follicle Activation in IVF Patients With Diminished Ovarian Reserve
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Premature ovarian insufficiency POI is cessation of ovarian function characterized by hypergonadotropic amenorrhea and hypoestrogenic syndrome before 40 years of age About 1 of women younger than 40 years old and 01 before 30 are affected POI imposes a great challenge on womens reproductive and long-term health such as infertility amenorrhea osteoporosis and cardiovascular disease Most patients already had impaired or complete loss of fecundity when diagnosed Currently no optimal regimen exists to ameliorate ovarian function Typically they end up with egg donation or adoption as an alternative way Less severe form of POI is diminished ovarian reserve DOR Although lack of consensus according to Bologna criteria cut off for DOR was defined as antral follicle count AFC 5-7 follicles or anti-Mullerian hormone AMH 05-11 ngml
Previously it has been showed that 24 of women with POI had resumption of ovarian function and 4 resulted in baby births These data indicates residual follicles are available in atrophic ovaries and have potential for development and even fertilization In routine IVF practice 15 percent of patients have poor ovarian response to ovarian stimulation Patients with DOR with a previous poor ovarian response cycles cancelled or yielding 3 oocytes with a conventional protocol might have benefit from the strategies increasing follicle activation and number of growing follicles and oocyte retrieved Therefore strategies enabling ovarian resumption predictable and follicle activation feasible are promising for POIDOR treatment Recently In vitro Activation IVA approach has been proposed and live births have been achieved in patients with POI Phosphatase and tensin homolog PTEN enzyme inhibitors and phosphatidylinositol-3 kinase activators could activate AKT pathway and activate the dormant follicles Ovarian fragmentation could lead to ovarian primary follicle growth by interfering with Hippo signaling pathway Residual follicles in patients with POI could be activated to develop for egg retrieval by combination of mechanical and chemical stimulation
In 2019 Zhang et al retrospectively analyzed the follicle development and pregnancy outcome in 80 POI patients after laparoscopic ovarian biopsyscratch without using chemical agents as was the case in IVA 11 1375 patients presented with ovarian function resumption three metaphases II oocytes were retrieved in 10 patients and two embryos were formed and freshly transferred followed by a healthy singleton delivery in 1 125 patient They concluded that the technique of ovarian biopsyscratch without chemical activation could promote follicle development in vivo suggesting it could bring promising benefits for some women with POI
In patient with POIDOR activation of residual follicles is a promising option and further studies are warranted Previous studies included laparoscopic surgery which may lead to possible surgical complications Without using chemical agents and laparoscopic surgery main object of this study is mechanical follicle activation with trans-vaginal ovarian needle puncture with 17 gauge oocyte pickup needle in IVF patients with DOR
Previously it has been showed that 24 of women with POI had resumption of ovarian function and 4 resulted in baby births These data indicates residual follicles are available in atrophic ovaries and have potential for development and even fertilization In routine IVF practice 15 percent of patients have poor ovarian response to ovarian stimulation Patients with DOR with a previous poor ovarian response cycles cancelled or yielding 3 oocytes with a conventional protocol might have benefit from the strategies increasing follicle activation and number of growing follicles and oocyte retrieved Therefore strategies enabling ovarian resumption predictable and follicle activation feasible are promising for POIDOR treatment Recently In vitro Activation IVA approach has been proposed and live births have been achieved in patients with POI Phosphatase and tensin homolog PTEN enzyme inhibitors and phosphatidylinositol-3 kinase activators could activate AKT pathway and activate the dormant follicles Ovarian fragmentation could lead to ovarian primary follicle growth by interfering with Hippo signaling pathway Residual follicles in patients with POI could be activated to develop for egg retrieval by combination of mechanical and chemical stimulation
In 2019 Zhang et al retrospectively analyzed the follicle development and pregnancy outcome in 80 POI patients after laparoscopic ovarian biopsyscratch without using chemical agents as was the case in IVA 11 1375 patients presented with ovarian function resumption three metaphases II oocytes were retrieved in 10 patients and two embryos were formed and freshly transferred followed by a healthy singleton delivery in 1 125 patient They concluded that the technique of ovarian biopsyscratch without chemical activation could promote follicle development in vivo suggesting it could bring promising benefits for some women with POI
In patient with POIDOR activation of residual follicles is a promising option and further studies are warranted Previous studies included laparoscopic surgery which may lead to possible surgical complications Without using chemical agents and laparoscopic surgery main object of this study is mechanical follicle activation with trans-vaginal ovarian needle puncture with 17 gauge oocyte pickup needle in IVF patients with DOR
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None