Ovarian Fragmentation Study (Crespo Medical Team)

IVF Clinical Trial

Official title:

Ovarian Fragmentation Study (Crespo Medical Team)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04306185
• Other study ID #: fibrotomia1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2020
• Source: Equipo Juana Crespo
• Contact: ANDER MORALES VICENTE
• Phone: 628802099
• Email: andermoralesvicente[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• IVF
• Menopause, Premature
• Ovarian Failure
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Procedure:
• OVARIAN FRAGMENTATION
BILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS

Locations

Country	Name	City	State
Spain	Ander Morales Vicente	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Equipo Juana Crespo

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

Callejo J, Salvador C, González-Nuñez S, Almeida L, Rodriguez L, Marqués 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. — View 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. Epub 2005 Aug 25. — View 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.f — View Citation

Isachenko V, Isachenko E, Keck G, Dittrich R, Montag M, van der Ven H, Mallmann P, Müller 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. — 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. Review. — View 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):227-30. doi: 10.1016/j.fertnstert.2012.09.029. Epub 2012 Oct 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- 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.	2 months.
Secondary	- Oocyte number and M-II oocyte (mature oocytes) before and after ovarian cortex fragmentation.		2 months
Secondary	- AntiMullerian hormone (AMH) serum levels before and two months after the procedure.		2 months.
Secondary	- Number of embryos before and after ovarian cortex fragmentation.		2 months
Secondary	- Clinical pregnancy rate following ovarian cortex fragmentation.		1 year