Study on the Association Between SXCI and RM and the Possible Genetic Mechanism

NCT02504281 | Completed DMC

• 1 other identifier: JIAI E2015-02
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility Female; Recurrent Miscarriage

Outcome Measures

Primary Outcomes (2)

• degree of X chromosome inactivation skewing

  Within 3 months after blood collection

• percentage of extremely skewed X chromosome inactivation(SXCI>90%) in each group

  Within 3 months after blood collection

Study Arms (2)

RM

Women 18-43 years of age who are scheduled for IVF or ICSI with a history of recurrent spontaneous abortion (miscarriage occurred earlier than 22 weeks of gestation for equal or greater than 3 times) in our IVF institute.

Control

Normal females who are visiting Shanghai JIAI genetics and IVF institute for IVF/ICSI because of only male factor.

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women visiting our centre for IVF/ICSI during 2015.01.01-2016.01.01 will enter RM group or control group according to their pregnant history or infertility factor. RM group: Women with a history of recurrent spontaneous abortion (miscarriage occurred earlier than 22 weeks of gestation for equal or greater than 2 times). Control group:Infertility women because of only male factor. Both groups meet the same elgibility criteria

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

Shanghai Jiai Genetics&IVF Institute

Shanghai, 200011, China

Location

Related Publications (1)

• Sui Y, Fu J, Zhang S, Li L, Sun X. Investigation of the role of X chromosome inactivation and androgen receptor CAG repeat polymorphisms in patients with recurrent pregnancy loss: a prospective case-control study. BMC Pregnancy Childbirth. 2022 Nov 2;22(1):805. doi: 10.1186/s12884-022-05113-z.

  PMID: 36324098 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from the females

MeSH Terms

Conditions

Infertility, Female; Abortion, Habitual

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Abortion, Spontaneous; Pregnancy Complications

Study Officials

• XIAOXI SUN, MD

  ShangHai Ji Ai Genetics & IVF Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2015
• First Posted: July 21, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 11, 2022

Record last verified: 2020-05

Locations

CN (1)