Influence of an Endometrioma on Oocyte Quality

Endometriosis Clinical Trial

— ENDOVOC  

Official title:

Influence of an Endometrioma on Oocyte Quality

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03352661
• Other study ID #: 1311-VGO-137-EM
• Status: Active, not recruiting
• Phase: N/A
• First received: January 17, 2017
• Last updated: November 20, 2017
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: January 2017
• Source: IVI Vigo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate if there are differences in oocyte quality depending on whether these oocytes come from an ovary in contact with an endometrioma.

Description:

There is no consensus for whether an endometrioma influences oocyte quality, as well as the possible mechanisms that induce them.

In this study, the oocyte maturation will proof oocyte quality: This mean, the percentage of oocytes in metaphase II obtained after stimulation, as well as the rate of oocytes fertilized in direct contact with an endometrioma.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients <40 years, BMI <30kg / m2,

Exclusion Criteria:

Related Conditions & MeSH terms

• Endometriosis

Intervention

Other:
• Collect retrospectively data
Collect retrospectively data

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IVI Vigo

References & Publications (3)

Filippi F, Benaglia L, Paffoni A, Restelli L, Vercellini P, Somigliana E, Fedele L. Ovarian endometriomas and oocyte quality: insights from in vitro fertilization cycles. Fertil Steril. 2014 Apr;101(4):988-93.e1. doi: 10.1016/j.fertnstert.2014.01.008. Epub 2014 Mar 3. — View Citation

Garcia-Velasco JA, Mahutte NG, Corona J, Zúñiga V, Gilés J, Arici A, Pellicer A. Removal of endometriomas before in vitro fertilization does not improve fertility outcomes: a matched, case-control study. Fertil Steril. 2004 May;81(5):1194-7. — View Citation

Garrido N, Navarro J, Remohí J, Simón C, Pellicer A. Follicular hormonal environment and embryo quality in women with endometriosis. Hum Reprod Update. 2000 Jan-Feb;6(1):67-74. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of mature oocytes	Number of MII oocytes from the total of cumulus granulosa cell-oocyte complex by 100	Up to 36 months
Primary	Fertilization rate	Number of oocytes with pronuclear activation after ICSI procedure from the total oocytes microinjected by 100	Up to 36 months