NCT04306185

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

8 months

First QC Date

March 6, 2020

Last Update Submit

March 10, 2020

Conditions

Ovarian FailurePremature Ovarian FailureIVF

Keywords

ovarian fragmentationKawamuraovarian rejuvenation

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 year

Secondary Outcomes (5)

  • - Follicle growth rate before and after ovarian cortex fragmentation.

    2 months.

  • - Oocyte number and M-II oocyte (mature oocytes) before and after ovarian cortex fragmentation.

    2 months

  • - AntiMullerian hormone (AMH) serum levels before and two months after the procedure.

    2 months.

  • - Number of embryos before and after ovarian cortex fragmentation.

    2 months

  • - Clinical pregnancy rate following ovarian cortex fragmentation.

    1 year

Study Arms (1)

OVARIAN FRAGMENTATION

EXPERIMENTAL

Ovarian fragmentation through laparoscopy in patients who meet criteria ( Poor ovarian responders and poor ovarian reserve).

Procedure: OVARIAN FRAGMENTATION

Interventions

OVARIAN FRAGMENTATIONPROCEDURE

BILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS

OVARIAN FRAGMENTATION

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ander Morales Vicente

Valencia, 46000, Spain

Location

Related Publications (7)

  • 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.

    PMID: 23102860BACKGROUND

  • 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.

    PMID: 23163109BACKGROUND

  • 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.

    PMID: 9886858BACKGROUND

  • 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.

    PMID: 16126712BACKGROUND

  • 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.

    PMID: 23647552BACKGROUND

  • 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: 27022685BACKGROUND

  • 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.

    PMID: 22698640RESULT

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Central Study Contacts

ANDER MORALES VICENTE

CONTACT

628802099andermoralesvicente@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 12, 2020

Study Start

May 1, 2020

Primary Completion

December 31, 2020

Study Completion

March 1, 2021

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

ES(1)