Observational Prospective Study of the Success of Single Embryo Transfer Implantation Related to Level of Follicular Fluid Cytokines Expression in Low Responders Infertile Patients Treated With r-hLH add-on Therapy in a Second Controlled Ovarian Stimulation Cycle.

Female Infertility Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02640261
• Other study ID #: Echelo
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2015
• Last updated: February 2, 2016
• Start date: January 2016
• Est. completion date: April 2018

Study information

• Verified date: December 2015
• Source: Centro di Procreazione Assistita Demetra
• Contact: Elisabetta Chelo, MD
• Phone: 0039 335457607
• Email: elisabetta.chelo[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The objective of our observational prospective study will be to compare, for women treated for infertility and included in a ICSI program, the implantation rate and delivery rate obtained after the transfer of a single blastocyst , chosen in a group of patients on the basis of the embryo morphology and in the other group on the basis of both embryo morphology and follicular fluid cytokines content.

100 IVF infertile patients , aged 32-39 years, with normal ovarian reserve, previously stimulated for their first cycle with standard short protocol (GnRH-Ant) and r-FSH alone, who have had a low ovarian response, Fort < 50% ( FORT Criteria, 2012; FORT= PFCX100/AFC), will be treated for the second cycle with standard short protocol (GnRH-Ant) and r-FSH plus r-LH , according to the standard established by our clinical practice.

Patients will be part of one of the following groups:

Group 1: single embryo transfer on day 5, according to standard embryo morphological criteria Group 2: single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• women age from < 38 years

• normal body mass index (BMI ) from 18 to 26

• parameters for ovarian reserve in the normal range (day 3 FSH levels < 10 mUI/ml ; day 3 E2 levels < 80 pg/ml; anti-mullerian hormone (AMH) levels > 1.5 ng/ml ; AFC (antral follicular count) > 6 )

Exclusion Criteria:

• polycystic ovary syndrome (PCOS)

• ovarian surgery

• pelvic endometriosis

• POR according to ESHRE criteria

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Female Infertility
• Infertility, Female

Locations

Country	Name	City	State
Italy	DEMETRA	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Procreazione Assistita Demetra

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate		2 years	No
Secondary	Delivery Rate		3 years	No