The effect of Vaginal Probiotic therapy in IVF outcome in cases of recurrent IVF failure(Implantation Failure)

Not Applicable

Conditions: Health Condition 1: O090- Supervision of pregnancy with history of infertility

Registration Number: CTRI/2022/06/043374

Lead Sponsor: Indira IVF Hospital Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Having two or more implantation failures after good embryo transfer(Gardenerâ??s grade 3/4/5/AA/AB/BA/BB).

2. Normal endometrial cavity evaluated by 3D ultrasound/ hysteroscopy

3. Normal parental karyotype

4. Subjects undergoing their IVF/ICSI cycle with own/ donor oocytes who will receivesingle embryo transfer of frozen blastocyst stage embryos (day 5/6) on an HRT cycle.

5. BMI: 18.5 - 30.0 kg/m2 (both inclusive).

6. Normal ovarian reserve (defined as AFC >= 8; AMH level >=1.2 ng/ml before the controlled ovarian stimulation (COS) initiation.

7. Negative serological tests for HIV, HBV, HCV, RPR.

8. Subjects who are willing to sign informed consent for participate in the study and willing to adhere to all protocol procedure.

Exclusion Criteria

1. Uncontrolled diabetes, hypertension, heart disease or autoimmune disease.

2. Male partner with severe male factor infertility (total sperm count <5 million per ml).

3. Those who will require surgically retrieved sperm for ICSI.

4. Subjects who are intrauterine device (IUD) carriers in the last three months before embryo

transfer.

5. Adenomyosis, unstable condition or any pathological finding affecting the endometrial cavity

6. Removal of myomas greater than 4 cm, within two months before embryo transfer

7. Salpingectomy/clipping for hydrosalpinx within one month before embryo transfer

8. Women who have received antibiotics (oral/ vaginal/parenteral) in the last one month before

embryo transfer.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implantation rate <br/ ><br>Timepoint: 6th gestational week

Secondary Outcome Measures

Name	Time	Method
Delivery rateTimepoint: after completion of 22 weeks of pregnancy;Live birth rateTimepoint: delivery;Miscarriage rateTimepoint: before 20th gestational weeks