Status:
UNKNOWN
RCT to Assess the Impact of Microbiome Status in Infertile IVF Patients at Their First IVF/ICSI Cycle
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
Reproductive & Genetic Hospital of CITIC-Xiangya
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Infertility, Female
IVF
Eligibility:
FEMALE
Up to 37 years
Phase:
NA
Brief Summary
Although the endometrium has been traditionally considered free of bacteria, recent studies have documented the presence of an endometrial microbiome. The uterine microbiome can be defined as Lactobac...
Detailed Description
Some authors have reported the existence of an endometrial microbiota present in healthy woman and different from that in the vagina. It is well known that the presence of pathogens (such as Gardnerel...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Patients whose written IC approved by the EC has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
- Patients undergoing their first IVF/ICSI cycle (first oocyte pick up, freezing all) with their own oocytes that will receive single embryo transfer of frozen blastocyst stage embryos (day 5/6) on an HRT cycle.
- At least 2 morphologically good quality embryos already vitrified in blastocyst stage (day 5/6).
- Maternal Age: ≤37 years to rule out embryo factor in aging patients.
- BMI: 18.5 - 30.0 kg / m2 (both inclusive).
- Normal ovarian reserve (defined as: AFC ≥ 8; AMH level ≥1.0 ng/ml and/or FSH \< 8 mU/ml) before the controlled ovarian stimulation (COS) initiation.
- Serum P levels ≤ 1.5 ng/ml, measured within 24 hours before the hCG administration in the COS cycle.
- Negative serological tests for HIV, HBV, HCV, RPR.
- Exclusion criteria
- Patients with repeated miscarriages (\> 2 previous biochemical pregnancies or \> 2 spontaneous miscarriages).
- Male partner with severe male factor (spermatozoa \< 2 million/ml). Semen donor is allowed.
- Patients who are intrauterine device (IUD) carriers in the last 3 months before sample collection.
- Adenomyosis or any pathological finding affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas \> 4 cm, or hydrosalpinx must be previously operated at least 3 months before the endometrial samples are obtained.(Note: Patients are allowed to participate if the pathology is corrected before performing any study procedure).
- Embryos analysed using preimplantation genetic testing for aneuploidies (PGT-A)
- Women who have received antibiotics in the last month previous to sample collection, except for the prophylaxis for the oocyte retrieval. In the control group, antibiotics cannot be provided during the ET cycle
- Illness or unstable medical condition that may put at risk the patient's safety and her compliance in the study
Exclusion
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
1018 Patients enrolled
Trial Details
Trial ID
NCT04686357
Start Date
August 1 2021
End Date
September 1 2023
Last Update
July 8 2021
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