Thrombophilia and Thyroid Autoimmunity in Implantation Failure and Recurrent Miscarriage

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

COMPLETED

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Thrombophilia, Thyroid Autoimmunity

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Interventions

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blood analysis

Intervention Type PROCEDURE

Eligibility Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Jose Bellver, MD

Role: PRINCIPAL_INVESTIGATOR

IVI Valencia

Locations

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Ivi Valencia

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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VLC-JB-0304-307-10

Identifier Type: -

Identifier Source: org_study_id