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Completed

NCT Number: NCT00485446

Thrombophilia and Thyroid Autoimmunity in Implantation Failure and Recurrent Miscarriage

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.

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Key information

Age range

18 year–37 year

Sex eligibility

Female

Study type

Observational

Primary location

Ivi Valencia

Valencia, 46015, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Blood analysis

Procedure

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Important dates

First posted
Jun 13, 2007
Registry last updated
Jun 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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