Health Condition 1: O090- Supervision of pregnancy with history of infertility
Conditions
Interventions
Intervention1: EvaNew®: Probiotic Vaginal Tablets with Standard IVF practice to be given for 8 days every month till delivery.
Control Intervention1: Placebo: Placebo (identical in size, shape, color
Sponsors
Indira IVF Hospital Pvt Ltd
NexGen Pharma India Pvt Ltd
Zuventus Healthcare
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Uncontrolled diabetes, hypertension, heart disease or autoimmune disease. 2. Male partner with severe male factor infertility (total sperm count 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Delivery rateTimepoint: after completion of 22 weeks of pregnancy;Live birth rateTimepoint: delivery;Miscarriage rateTimepoint: before 20th gestational weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Implantation rate Timepoint: 6th gestational week | — |
Countries
India
Contacts
Public ContactDr Vipin Chandra
Clinical and Lab Operation Department,Indira IVF hospital Udaipur
Outcome results
None listed