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Clinical Trials/NCT02640261
NCT02640261
Unknown
Not Applicable

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 Demetra1 site in 1 country100 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Female Infertility
Sponsor
Centro di Procreazione Assistita Demetra
Enrollment
100
Locations
1
Primary Endpoint
Implantation rate
Last Updated
10 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
April 2018
Last Updated
10 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Centro di Procreazione Assistita Demetra
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Implantation rate

Time Frame: 2 years

Secondary Outcomes

  • Delivery Rate(3 years)

Study Sites (1)

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