Recurrent Miscarriage Clinical Trial
Official title:
Study on the Association Between Skewed X Chromosome Inactivation(SXCI) and Recurrent Miscarriage(RM) and the Possible Genetic Mechanism
NCT number | NCT02504281 |
Other study ID # | JIAI E2015-02 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | December 2021 |
Verified date | May 2020 |
Source | ShangHai Ji Ai Genetics & IVF Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To determine whether there is higher incidence of skewed X chromosome inactivation(SXCI) in the recurrent miscarriage(RM) population compared with normal population, and verify the existing hypothesis of the possible genetic mechanisms underlying the association between SXCI and RM.
Status | Completed |
Enrollment | 257 |
Est. completion date | December 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 43 Years |
Eligibility | Inclusion Criteria: - 1) regular menstrual cycles and normal level of E2, P, FSH, LH, T, RPL in the early follicular phase; 2) no history of gynecologic or other pelvic operations; 3) no history of hormone medicine application in the last 3 months; 4) no history of poison contact; 5) normal uterine and adnexal ultrasonography; 6) TORCH(-), chlamydia(-), mycoplasma(-), normal leucorrhoea routine, anti-phospholipid antibody (-), antinuclear antibody(-); 7) for the couple, no blood type incompatibility or ABO antibody IgG=1:64 and normal blood chromosome analysis; 8) condoms are used for contraception. Exclusion Criteria: - 1) BMI<18.5 or >24.9; 2) hydrosalpinx without operation; endometriosis; polycystic ovary syndrome; adenomyosis; uterine leiomyomata(submucous myoma or non-submucous myoma which size was exceed 4cm and/or with the compressed endometrium);uterine cavity lesions(such as uterine malformation, intrauterine adhesions, the septate uterus, endometritis etc); 3) the former abortion is because of luteal phase defect without treatment; 4) FSH=12IU/L or AMH<1.2ng/ml 5) thyroid dysfunction or increased CA125 level; 6) acute inflammation of genitourinary system or STD carriers; 7) unable to comply with the study procedures. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Jiai Genetics&IVF Institute | Shanghai |
Lead Sponsor | Collaborator |
---|---|
ShangHai Ji Ai Genetics & IVF Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | degree of X chromosome inactivation skewing | Within 3 months after blood collection | ||
Primary | percentage of extremely skewed X chromosome inactivation(SXCI>90%) in each group | Within 3 months after blood collection |
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