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.

NCT02640261 | Unknown

• 1 other identifier: Echelo
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Infertility

Keywords

r-hLH; Cytokines; Follicular Fluid

Outcome Measures

Primary Outcomes (1)

• Implantation rate

  2 years

Secondary Outcomes (1)

• Delivery Rate

  3 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Normogonadotropic Infertile Women that failed the first IVFcycle and require r-hLh add on therapy as per Demetra clinical standard procedures

You may qualify if:

• 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 )

You may not qualify if:

• polycystic ovary syndrome (PCOS)
• ovarian surgery
• pelvic endometriosis
• POR according to ESHRE criteria

Sponsors & Collaborators

• Centro di Procreazione Assistita Demetra: lead

Study Sites (1)

DEMETRA

Florence, Italy, 50129, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Follicular Fluid

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Elisabetta Chelo, MD

  Clinica Center DEMETRA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabetta Chelo, MD

CONTACT

0039 335457607; elisabetta.chelo@gmail.com

Cristiana Barbosa, MD

CONTACT

003903478838377; quartim.barbosa@centrodemetra.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 28, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2018
• Last Updated: February 3, 2016

Record last verified: 2015-12

Locations

IT (1)