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Recurrent Failures in assIsted Reproductive Techniques (The FIRST Registry)

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ClinicalTrials.gov Identifier: NCT02685800
Recruitment Status : Recruiting
First Posted : February 19, 2016
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Elvira Grandone, MD, Head of Unit, Casa Sollievo della Sofferenza IRCCS

Brief Summary:

Assisted Reproductive Technologies (ARTs) are widely used in couples with fertility problems. However, despite ART treatment options have evolved over time, the implantation rate remains rather low.

A possible role for inherited and acquired thrombophilias has been invoked, especially in women with previous implantation failures. However, several factors could play a role in these conditions.

A potential benefit of low-molecular-weight heparin (LMWH) in improving ART outcomes, independently of the presence of thrombophilia, has been recently suggested.

This register is designed in order to better define all possible variables influencing ART outcome and improve clinical management of women with previous implantation failures. During this study the investigators will collect and evaluate clinical data regarding the first cycle in women with previous ART failures.


Condition or disease
Infertility

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 624 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Months
Official Title: A Registry on Outcomes in Women Undergoing Assisted Reproductive Techniques After Recurrent Failures
Study Start Date : October 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020



Primary Outcome Measures :
  1. Number of live births [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Number of clinical pregnancies after ART [ Time Frame: 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive women undergoing ART after recurrent failures.
Criteria

Inclusion Criteria:

  • 2 or more implantation failures/losses of clinical pregnancies after ART
  • ART cycle at enrolment
  • Informed consent

Exclusion Criteria:

  • Ovarian hypofunction
  • Uterine pathology
  • Hydrosalpinges
  • Previous inclusion in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685800


Contacts
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Contact: Elvira Grandone e.grandone@operapadrepio.it
Contact: Michela Villani mvillani27@libero.it

Locations
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Italy
IRCCS Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
Contact: Elvira Grandone         
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
Investigators
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Principal Investigator: Elvira Grandone IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo, Foggia, Italy

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elvira Grandone, MD, Head of Unit, Head of Unit, Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier: NCT02685800     History of Changes
Other Study ID Numbers: FIRST - V 1_28 Ago 15
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female