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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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02640261
Enrollment
100
Registered
2015-12-28
Start date
2016-01-31
Completion date
2018-04-30
Last updated
2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility

Keywords

r-hLH, Cytokines, Follicular Fluid

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.

Interventions

None listed

Sponsors

Centro di Procreazione Assistita Demetra
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Implantation rate2 years

Secondary

MeasureTime frame
Delivery Rate3 years

Countries

Italy

Contacts

Primary ContactElisabetta Chelo, MD
elisabetta.chelo@gmail.com0039 335457607
Backup ContactCristiana Barbosa, MD
quartim.barbosa@centrodemetra.com003903478838377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026