Ovarian Fragmentation Study (Crespo Medical Team)
Primary Purpose
Ovarian Failure, Premature Ovarian Failure, IVF
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
OVARIAN FRAGMENTATION
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Failure focused on measuring ovarian fragmentation, Kawamura, ovarian rejuvenation
Eligibility Criteria
Inclusion Criteria:
- Abdominal surgery need for fertility cause.
- Bad embryo quality (>2 cycles with < 1 embryo A-B quality. With:
A. Poor ovarian responders (previous ≤ 3 retrieved metaphase II oocytes) in a conventional cycle.
B. Decreased ovarian reserve (antral follicle count (AFC) ≤ 5 or antiMullerian hormone (AMH) ≤ 0.5 ng/mL).
C.Premature ovarian insufficiency according to:
- Patients < 40 years old.
- At least 1 year of amenorrhea.
- Follitropin serum levels (FSH) >35 IU/ml in two serum samples separated by at least 1 month.
- Estradiol serum levels (E2) < 20 pg/mL.
Exclusion Criteria:
- Clinical/ultrasonographical signs of severe endometriosis ( or endometrioma).
- Age over 45 years (EMC)
- Previous ovarian/pelvic surgery. Unilateral oophorectomy.
- Body Mass Index > 30
- Previous gonadotoxic treatment.
- Genito-urinary tract malformations.
- Inform consent unsigned.
Sites / Locations
- Ander Morales Vicente
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OVARIAN FRAGMENTATION
Arm Description
Ovarian fragmentation through laparoscopy in patients who meet criteria ( Poor ovarian responders and poor ovarian reserve).
Outcomes
Primary Outcome Measures
Embryo quality improvement following ovarian fragmentation (Using ASEBIR Embryo Classification, 2015)
Embryo quality improvement following ovarian cortex fragmentation in poor ovarian responders or patients with premature ovarian insufficency using ASEBIR Classification (2015).
Secondary Outcome Measures
- Follicle growth rate before and after ovarian cortex fragmentation.
Number of antral Follicles in IVF treatment before ovarian fragmentation and after IVF following ovarian fragmentation.
- Oocyte number and M-II oocyte (mature oocytes) before and after ovarian cortex fragmentation.
- AntiMullerian hormone (AMH) serum levels before and two months after the procedure.
- Number of embryos before and after ovarian cortex fragmentation.
- Clinical pregnancy rate following ovarian cortex fragmentation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04306185
Brief Title
Ovarian Fragmentation Study (Crespo Medical Team)
Official Title
Ovarian Fragmentation Study (Crespo Medical Team)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Equipo Juana Crespo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a study designed to validate Kawamura´s theory and investigation of activation of primordial follicles through ovarian cortex fragmentation. Our aim is to evaluate embryo quality following this procedure in poor ovarian responders and patients with decreased ovarian reserve. Secondary objectives are to assess potential association with the number of oocytes retrieved and pregnancy rates after IVF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Failure, Premature Ovarian Failure, IVF
Keywords
ovarian fragmentation, Kawamura, ovarian rejuvenation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OVARIAN FRAGMENTATION
Arm Type
Experimental
Arm Description
Ovarian fragmentation through laparoscopy in patients who meet criteria ( Poor ovarian responders and poor ovarian reserve).
Intervention Type
Procedure
Intervention Name(s)
OVARIAN FRAGMENTATION
Intervention Description
BILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS
Primary Outcome Measure Information:
Title
Embryo quality improvement following ovarian fragmentation (Using ASEBIR Embryo Classification, 2015)
Description
Embryo quality improvement following ovarian cortex fragmentation in poor ovarian responders or patients with premature ovarian insufficency using ASEBIR Classification (2015).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
- Follicle growth rate before and after ovarian cortex fragmentation.
Description
Number of antral Follicles in IVF treatment before ovarian fragmentation and after IVF following ovarian fragmentation.
Time Frame
2 months.
Title
- Oocyte number and M-II oocyte (mature oocytes) before and after ovarian cortex fragmentation.
Time Frame
2 months
Title
- AntiMullerian hormone (AMH) serum levels before and two months after the procedure.
Time Frame
2 months.
Title
- Number of embryos before and after ovarian cortex fragmentation.
Time Frame
2 months
Title
- Clinical pregnancy rate following ovarian cortex fragmentation.
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Abdominal surgery need for fertility cause.
Bad embryo quality (>2 cycles with < 1 embryo A-B quality. With:
A. Poor ovarian responders (previous ≤ 3 retrieved metaphase II oocytes) in a conventional cycle.
B. Decreased ovarian reserve (antral follicle count (AFC) ≤ 5 or antiMullerian hormone (AMH) ≤ 0.5 ng/mL).
C.Premature ovarian insufficiency according to:
Patients < 40 years old.
At least 1 year of amenorrhea.
Follitropin serum levels (FSH) >35 IU/ml in two serum samples separated by at least 1 month.
Estradiol serum levels (E2) < 20 pg/mL.
Exclusion Criteria:
Clinical/ultrasonographical signs of severe endometriosis ( or endometrioma).
Age over 45 years (EMC)
Previous ovarian/pelvic surgery. Unilateral oophorectomy.
Body Mass Index > 30
Previous gonadotoxic treatment.
Genito-urinary tract malformations.
Inform consent unsigned.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANDER MORALES VICENTE
Phone
628802099
Email
andermoralesvicente@gmail.com
Facility Information:
Facility Name
Ander Morales Vicente
City
Valencia
ZIP/Postal Code
46000
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23102860
Citation
Revelli A, Marchino G, Dolfin E, Molinari E, Delle Piane L, Salvagno F, Benedetto C. Live birth after orthotopic grafting of autologous cryopreserved ovarian tissue and spontaneous conception in Italy. Fertil Steril. 2013 Jan;99(1):227-230. doi: 10.1016/j.fertnstert.2012.09.029. Epub 2012 Oct 23.
Results Reference
background
PubMed Identifier
23163109
Citation
Isachenko V, Isachenko E, Keck G, Dittrich R, Montag M, van der Ven H, Mallmann P, Muller A, Distler W, Beckmann MW, Rahimi G. First live birth in germany after re-transplantation of cryopreserved ovarian tissue: original device for initiation of ice formation. Clin Lab. 2012;58(9-10):933-8.
Results Reference
background
PubMed Identifier
9886858
Citation
Baird DT, Webb R, Campbell BK, Harkness LM, Gosden RG. Long-term ovarian function in sheep after ovariectomy and transplantation of autografts stored at -196 C. Endocrinology. 1999 Jan;140(1):462-71. doi: 10.1210/endo.140.1.6453.
Results Reference
background
PubMed Identifier
16126712
Citation
Donnez J, Dolmans MM, Demylle D, Jadoul P, Pirard C, Squifflet J, Martinez-Madrid B, Van Langendonckt A. Restoration of ovarian function after orthotopic (intraovarian and periovarian) transplantation of cryopreserved ovarian tissue in a woman treated by bone marrow transplantation for sickle cell anaemia: case report. Hum Reprod. 2006 Jan;21(1):183-8. doi: 10.1093/humrep/dei268. Epub 2005 Aug 25.
Results Reference
background
PubMed Identifier
23647552
Citation
Callejo J, Salvador C, Gonzalez-Nunez S, Almeida L, Rodriguez L, Marques L, Valls A, Lailla JM. Live birth in a woman without ovaries after autograft of frozen-thawed ovarian tissue combined with growth factors. J Ovarian Res. 2013 May 7;6(1):33. doi: 10.1186/1757-2215-6-33.
Results Reference
background
PubMed Identifier
27022685
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.
Results Reference
background
PubMed Identifier
22698640
Citation
Donnez J, Jadoul P, Pirard C, Hutchings G, Demylle D, Squifflet J, Smitz J, Dolmans MM. Live birth after transplantation of frozen-thawed ovarian tissue after bilateral oophorectomy for benign disease. Fertil Steril. 2012 Sep;98(3):720-5. doi: 10.1016/j.fertnstert.2012.05.017. Epub 2012 Jun 13.
Results Reference
result
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Ovarian Fragmentation Study (Crespo Medical Team)
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