Clinical trial NCT04306185: Ovarian Fragmentation Study (Crespo Medical Team)
Official title: Ovarian Fragmentation Study (Crespo Medical Team)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Failure
Premature Ovarian Failure
IVF
Keywords: ovarian fragmentation
Kawamura
ovarian rejuvenation
Lead sponsor: Equipo Juana Crespo
Sponsor class: NETWORK
First posted: 2020-03-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

1. Clinical/ultrasonographical signs of severe endometriosis ( or endometrioma).
2. Age over 45 years (EMC)
3. Previous ovarian/pelvic surgery. Unilateral oophorectomy.
4. Body Mass Index \> 30
5. Previous gonadotoxic treatment.
6. Genito-urinary tract malformations.
7. Inform consent unsigned.

Primary outcomes:
measure: Embryo quality improvement following ovarian fragmentation (Using ASEBIR Embryo Classification, 2015)
timeFrame: 1 year
Secondary outcomes:
measure: - Follicle growth rate before and after ovarian cortex fragmentation.
timeFrame: 2 months.
measure: - Oocyte number and M-II oocyte (mature oocytes) before and after ovarian cortex fragmentation.
timeFrame: 2 months
measure: - AntiMullerian hormone (AMH) serum levels before and two months after the procedure.
timeFrame: 2 months.
measure: - Number of embryos before and after ovarian cortex fragmentation.
timeFrame: 2 months
measure: - Clinical pregnancy rate following ovarian cortex fragmentation.
timeFrame: 1 year
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ander Morales Vicente
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.