Whether Vaginal Microbiota Affects Pregnancy Outcomes After Embryo Transfer

NCT06296615 | Completed

• 1 other identifier: 2020-022
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about vaginal microbial characteristics in the patients under in vitro fertilization treatment. The study aims to address the following questions: (1) Is there any difference in microbial composition between the pregnancy and non-pregnancy groups? (2) Is there any differences in specific bacterial species between the two groups? (3) What are the favorable or unfavorable profiles of vaginal microbiota associated with achieving pregnancy? Patients will be asked to complete a questionnaire regarding their basic characteristics, and vaginal secretions will be collected via vaginal swab during frozen-blastocyst transfer procedures. The study will compare vaginal microbiota between pregnant and non-pregnant patients to assess its potential influence on clinical outcomes.

Conditions

Infertility, Female; Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• Rate of clinical pregnancy

  Clinical pregnancy is defined as the presence of a gestational sac confirmed by transvaginal ultrasound examination.

  4 weeks after embryo transfer for the patient

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The patients who are under IVF treatment and have at least one high-quality euploid blastocysts to transfer. In addition, the participants should not have severe conditions that could adversely affect pregnancy outcomes, such as premature ovarian insufficiency or severe endometriosis.

You may qualify if:

• Woman of 20-40 years of age
• Woman who have regular menstrual cycles and normal level of E2, P, FSH, LH, T, RPL in the early follicular phase
• Women who are scheduled for PGT cycles in IVF center and have a euploid blastocyst to transfer
• Women who have normal uterine and adnexal ultrasonography

You may not qualify if:

• embryos underwent double vitrification or a second biopsy
• patients having premature ovarian insufficiency (FSH \> 12 mIU/ml and AMH \< 1.1 ng/ml), abnormal uterine cavity, systemic disease, endometriosis American Fertility Score III/IV, or cancer
• those testing positive for mold spores or trichomonas in vaginal secretion examination and subjectively reported abnormal vaginal symptoms such as vaginal itching at 7 days before embryo transfer

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

Shanghai Ji Ai Genetics & IVF Institute

Shanghai, China

Location

Related Publications (1)

• Koedooder R, Singer M, Schoenmakers S, Savelkoul PHM, Morre SA, de Jonge JD, Poort L, Cuypers WJSS, Beckers NGM, Broekmans FJM, Cohlen BJ, den Hartog JE, Fleischer K, Lambalk CB, Smeenk JMJS, Budding AE, Laven JSE. The vaginal microbiome as a predictor for outcome of in vitro fertilization with or without intracytoplasmic sperm injection: a prospective study. Hum Reprod. 2019 Jun 4;34(6):1042-1054. doi: 10.1093/humrep/dez065.

  PMID: 31119299 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

vaginal secretion

MeSH Terms

Conditions

Infertility, Female; Communicable Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yijuan Sun, Ph.D

  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: February 28, 2024
• First Posted: March 6, 2024
• Study Start: April 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

CN (1)