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.

NCT ID: NCT02640261

Last Updated: 2016-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Female Infertility

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centro di Procreazione Assistita Demetra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabetta Chelo, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Center DEMETRA

Locations

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DEMETRA

Florence, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elisabetta Chelo, MD

Role: CONTACT

0039 335457607

Cristiana Barbosa, MD

Role: CONTACT

003903478838377

Facility Contacts

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Cristiana Barbosa, MD

Role: primary

00393478838377

Other Identifiers

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Echelo

Identifier Type: -

Identifier Source: org_study_id

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