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.

Centro di Procreazione Assistita Demetra

Status: Unknown

Conditions: Female Infertility

Study type: Observational

Funder types: Other

Identifiers

NCT02640261

Echelo

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Group 1

Description:

Single embryo transfer on day 5, according to standard embryo morphological criteria

Group 2

Description:

Single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF.