Effect of Reproductive Tract Microbiota on Pregnancy Outcome in IVF/ICSI

NCT04293068 | Unknown DMC

• 1 other identifier: 2020Microbiota
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A single center，observational cohort study to explore the relationship between reproductive tract microbiota and pregnancy outcome in the patients accepted IVF/ICSI. To investigate whether there is a correlation between reproductive tract microbiota and IVF/ICSI outcomes. Whether there are differences in reproductive tract microbiota (such as vagina, follicular fluid, uterine cavity, etc.) in patients with different pregnancy outcomes.

Conditions

Infertility; Recurrent Implantation Failure; Recurrent Miscarriage

Keywords

Infertility; Recurrent implantation failure; Recurrent spontaneous abortion; Reproductive tract microbiota; In vitro fertilization

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  One or more observed gestational sac or definitive clinical signs of pregnancy under ultrasonography at 4 weeks after embryo transfer (including clinically documented ectopic pregnancy)

  4 weeks after embryo transfer

Secondary Outcomes (9)

• Microbiota ratio

  About 2 months later after samples collection

• Oocyte retrieval

  36 hours after HCG injection

• Fertilization rate

  16-20 hours after oocyte retrieval

• Available embryo

  72 hours after oocyte retrieval

• Good quality embryo

  72 hours after oocyte retrieval

Study Arms (3)

Control group

Related tests were normal, because the male factor alone required the first IVF/ICSI cycle; Follow-up of included patients was conducted to determine whether embryo transplantation was performed, and the score of transferred embryos was recorded, and the final control group would be confirmed after achieving clinical pregnancy

Recurrent implantation failure

Previous ≥3 consecutive embryo transfer failures

Recurrent spontaneous abortion(miscarriage)

≥2 consecutive spontaneous abortions or embryo damage

Eligibility Criteria

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

Study Population

The recruited participants conformed to the eligibility criteria will be divided into 3 groups (Control group: male infertility; RIF group; RM group). Each group will be recruited at least 30 cases.

You may qualify if:

• The sampling cycle of all samples requires no use of glucocorticoids, antibiotics and vaginal drugs within the cycle of this month; No cervical treatment within a week; No irrigation, asexual life within 5 days; Strict contraception in this month;
• Male infertility (Related tests were normal, because the male factor alone required the first IVF/ICSI cycle; Follow-up of included patients was conducted to determine whether embryo transplantation was performed, and the score of transferred embryos was recorded, and the final control group would be confirmed after achieving clinical pregnancy) OR Recurrent implantation failure (Previous ≥3 consecutive embryo transfer failures) OR Recurrent spontaneous abortion (≥2 consecutive spontaneous abortions or embryo damage)

You may not qualify if:

• Acute genital tract inflammation (including vagina, cervix, endometrium and pelvic cavity)
• Previous diagnosis of intrauterine adhesion or mechanical damage to the endometrium; drugs and surgery can not restore the function (endometrium thickness \<7mm in the window period before transplantation)
• Untreated hydrosalpinx, submucosal or \>4cm intramuscular uterine fibroids, adenomyosis, stage III-IV endometriosis confirmed by surgery, endometritis diagnosed by pathology and other definite factors might affect implantation
• Chromosomal abnormalities in couples may lead to miscarriage, fetal malformation and other diseases
• Previous examination indicated the existence of DOR (FSH≥9U/L and/or AMH ≤1.1ng/ml and/or AFC≤5-7)
• Those with polycystic ovary syndrome, high prolactinemia and other ovulation disorders
• Those with congenital adrenal hyperplasia, hypothyroidism/hyperthyroidism, diabetes, metabolic syndrome and other endocrine and metabolic diseases
• BMI less than 18 or more than 25
• Previous autoimmune diseases such as anti-heart coagulation syndrome, sjogren's syndrome and rheumatoid arthritis
• Prethrombotic hypercoagulability or family history of thrombosis
• Female genital tract deformities (whether or not surgically corrected)
• Those within the programme of oocyte or sperm donor
• Those with previous history of various types of cancer or serious systemic diseases (such as heart, lung and blood diseases) or mental diseases

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Infertility; Abortion, Habitual; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Rong Li, M.D.

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Fen-Ting Liu, Bachelor

CONTACT

15625120620; 624603036@qq.com

Shuo Yang, M.D.

CONTACT

13810349928; yangshuo@263.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Reproductive Medical Center

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 3, 2020
• Study Start: August 18, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

CN (1)