Infertility, FemaleNCT06296615
Whether Vaginal Microbiota Affects Pregnancy Outcomes After Embryo Transfer
An observational study of Infertility, Female and Microbial Colonization, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Microbial Colonization
- How many people
- 161 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Despite clinicians' efforts to optimize clinical protocols in assisted reproduction, the clinical pregnancy rate continues to be unsatisfactory. Microbial dysbiosis has been implicated in numerous adverse reproductive conditions. The examination of microorganisms remains a promising avenue for improving clinical outcomes following embryo transfer in in-vitro fertilization (IVF) centers.
The vagina serves as the primary barrier, separating the external environment from the upper reproductive tract. Recent studies employing deep sequencing of microorganisms in IVF patients have shed light on the association between the diversity of vaginal microbiota and the abundance of specific microorganisms with crucial reproductive outcomes. However, certain studies have yielded inconsistent results, suggesting either no discernible association between vaginal microbiota and IVF outcomes or varying disparities in bacterial composition between groups with favorable and unfavorable clinical outcomes. Research into predictive models based on reproductive tract microbiota remains relatively limited. Hence, further studies are warranted to elucidate the correlation between vaginal microorganisms and pregnancy outcomes.
The aim of this study is to explore the characteristics of vaginal microbiota in patients undergoing IVF treatment and examine potential differences between those who achieve pregnancy and those who do not. 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. High-throughput sequencing of the V3-V4 variable region of the 16S rRNA gene will be conducted on the vaginal secretions of participants. Specifically, investigators will: (1) compare Alpha diversity between the two groups; (2) compare Beta diversity between the two groups; (3) investigate whether there are any differences in specific bacterial taxa between the two groups; (4) determine the favorable or unfavorable profiles of vaginal microbiota associated with achieving pregnancy; and (5) explore methods for predicting pregnancy outcomes based on vaginal microbiota. This study presents a prospective approach to utilizing microbial characteristics for predicting pregnancy outcomes before implementing further interventions, offering potential refinement of treatment strategies for IVF patients.
- Conditions
- Infertility, Female, Microbial Colonization
- Medical subject headings
- Infertility, Female, Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinical pregnancy
Clinical pregnancy is defined as the presence of a gestational sac confirmed by transvaginal ultrasound examination.
Measured: 4 weeks after embryo transfer for the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Apr 2021
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yijuan Sun, Ph.D, Study director, ShangHai Ji Ai Genetics & IVF Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296615
- Sponsor's protocol ID
- 2020-022
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31119299
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whether Vaginal Microbiota Affects Pregnancy Outcomes After Embryo Transfer
- ClinicalTrials.gov ID
- NCT06296615
- Acronym / sponsor ID
- 2020-022
- Conditions
- Infertility, Female, Microbial Colonization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF InstituteUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite clinicians' efforts to optimize clinical protocols in assisted reproduction, the clinical pregnancy rate continues to be unsatisfactory. Microbial dysbiosis has been implicated in numerous adverse reproductive conditions. The examination of microorganisms remains a promising avenue for improving clinical outcomes following embryo transfer in in-vitro fertilization (IVF) centers.
The vagina serves as the primary barrier, separating the external environment from the upper reproductive tract. Recent studies employing deep sequencing of microorganisms in IVF patients have shed light on the association between the diversity of vaginal microbiota and the abundance of specific microorganisms with crucial reproductive outcomes. However, certain studies have yielded inconsistent results, suggesting either no discernible association between vaginal microbiota and IVF outcomes or varying disparities in bacterial composition between groups with favorable and unfavorable clinical outcomes. Research into predictive models based on reproductive tract microbiota remains relatively limited. Hence, further studies are warranted to elucidate the correlation between vaginal microorganisms and pregnancy outcomes.
The aim of this study is to explore the characteristics of vaginal microbiota in patients undergoing IVF treatment and examine potential differences between those who achieve pregnancy and those who do not. 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. High-throughput sequencing of the V3-V4 variable region of the 16S rRNA gene will be conducted on the vaginal secretions of participants. Specifically, investigators will: (1) compare Alpha diversity between the two groups; (2) compare Beta diversity between the two groups; (3) investigate whether there are any differences in specific bacterial taxa between the two groups; (4) determine the favorable or unfavorable profiles of vaginal microbiota associated with achieving pregnancy; and (5) explore methods for predicting pregnancy outcomes based on vaginal microbiota. This study presents a prospective approach to utilizing microbial characteristics for predicting pregnancy outcomes before implementing further interventions, offering potential refinement of treatment strategies for IVF patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of clinical pregnancy
Time frame: 4 weeks after embryo transfer for the patient
Clinical pregnancy is defined as the presence of a gestational sac confirmed by transvaginal ultrasound examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Results publication: PubMed 31119299Koedooder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yijuan Sun, Ph.D study director
ShangHai Ji Ai Genetics & IVF Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Microbial Colonization, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinical pregnancy (time frame: 4 weeks after embryo transfer for the patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06296615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.