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Thrombophilia and Thyroid Autoimmunity in Implantation Failure and Recurrent Miscarriage

Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)
Overall Status
Completed
CT.gov ID
NCT00485446
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

This study was designed to evaluate the incidence of both, inherited and adquired thrombophilia, and thyroid autoinmunity in unknown infertility (UI), implantation failure (IF) and recurrent miscarriage (RM). To focus on these particular disorders and to rule out another potential confounding variables, 4 particular groups of women were created. Only young women (< 38 years old), patients whose previous preimplantation genetic screening (PGS) cycles displayed an acceptable rate of aneploidies, and women without organic uterine abnormality, autoimmune disease or endocrine disorder were included in the study.

Condition or Disease Intervention/Treatment Phase
  • Procedure: blood analysis

Study Design

Study Type:
Observational
Observational Model:
Defined Population
Time Perspective:
Other

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 37 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:

    1. The control group included 32 oocyte donors, 18-35 years old, white caucasian, with normal karyotype, no miscarriages, and previous healthy live born infants without pregnancy complications.

    2. The UI group consisted of 31 couples with > 1 year infertility , < 38 years of age, normal ovarian function, normal hysterosalpingography and transvaginal ultrasound scan of the uterus and ovaries, normal karyotype in both parents, and normozoospermia.

    3. The IF group included 26 couples with 3.9±1.1 IVF failures with embryo transfer of at least 2 good quality embryos. They were < 38 years old, white caucasian, and had normal uterus by vaginal ultrasound and/or hysterosalpingography/ hysteroscopy. Moreover, endocrine disorders or autoimmune diseases were ruled out, a normal karyotype was found in both parents. The male had a sperm concentration > 5 mill/ml.They also had a PGS cycle with ≥ 60% of normal embryos.

    4. The group of women with RM (n = 30) had 3.2±1.3 (range: 2-9) previous miscarriages. They were < 38 years old, white caucasian, with normal uterus by vaginal ultrasound and/or hysterosalpingography/ hysteroscopy. Also, no endocrine anomalies or autoimmune diseases were found, and both parents had normal karyotype. Sperm concentration was > 5 mill/ml. Only 6 women had 2 miscarriages (20%) and the remaining 24 women at least

    5. They also had a PGS cycle with ≥ 60% of normal embryos.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ivi Valencia Valencia Spain 46015

    Sponsors and Collaborators

    • Instituto Valenciano de Infertilidad, IVI VALENCIA

    Investigators

    • Principal Investigator: Jose Bellver, MD, IVI Valencia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00485446
    Other Study ID Numbers:
    • VLC-JB-0304-307-10
    First Posted:
    Jun 13, 2007
    Last Update Posted:
    Jun 13, 2007
    Last Verified:
    Jun 1, 2007
    Additional relevant MeSH terms:
    Thrombophilia
    Thyroid Diseases
    Autoimmune Diseases

    Study Results

    No Results Posted as of Jun 13, 2007