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Role of endometrial injury in the success of IVF in patients with failed implantation in previous IVF cycles and its genetic basis.

Not Applicable
Conditions
Health Condition 1: null- healthy and with failed implantation in previous IVF cycle.
Registration Number
CTRI/2013/12/004206
Lead Sponsor
All India Institute of Medical Sciences AIIMS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

1.Women less than 38 years old.

2.Women who have >1 previous failed IVF-ET cycles.

3.Women with good ovarian reserve (AFC >8, AMH 2-6 ng/ml, FSH level <8 mIU/ml)

4.No uterine manipulation within last 3 months (e.g. hysteroscopy, myomectomy etc)

5.Women willing to participate in the trial.

Exclusion Criteria

1.Women more than 38 years old with confounding factors(eg Poor ovarian reserve)

2.Women with Grade III & IV Endometriosis.

3.Women with history of septal resection, adhesiolysis &abnormal uterine cavity.

4.Women with possible causes for failure of implantation such as diabetes mellitus, hypertension, autoimmune diseases..

5.Women not willing to participate in the trial.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1) Implantation rate (Time frame; 15-20 days of embryo transfer, serum <br/ ><br>beta hCG level) <br/ ><br> Implantation rate will be calculated as <br/ ><br>a) Number of patients with positive Serum beta hCG on Day 16 of ET <br/ ><br>b) Number of gestational sacs as seen on transvaginal sonography divided by the number of embryos transferred. <br/ ><br>2) Clinical pregnancy rate (Time frame; 8-10 weeks, appearance of <br/ ><br>cardiac activity) <br/ ><br>3) Genomic wide Transcriptomic basis <br/ ><br>Timepoint: 1) Implantation rate (Time frame; 15-20 days of embryo transfer, serum <br/ ><br>beta hCG level) <br/ ><br> Implantation rate will be calculated as <br/ ><br>a) Number of patients with positive Serum beta hCG on Day 16 of ET <br/ ><br>b) Number of gestational sacs as seen on transvaginal sonography divided by the number of embryos transferred. <br/ ><br>2) Clinical pregnancy rate (Time frame; 8-10 weeks, appearance of <br/ ><br>cardiac activity) <br/ ><br>3) Genomic wide Transcriptomic basis
Secondary Outcome Measures
NameTimeMethod
1. Pregnancy rate/ ongoing pregnancy rate. (Time frame; till 12 weeks of <br/ ><br>gestation) <br/ ><br>2. Miscarriage Rate (Time frame: till 12 weeks of gestation) <br/ ><br>3. Endometrial thickness during stimulation (Time frame: during <br/ ><br>stimulation cycle designated as safety issue: No <br/ ><br>Timepoint: 1. Pregnancy rate/ ongoing pregnancy rate. (Time frame; till 12 weeks of <br/ ><br>gestation) <br/ ><br>2. Miscarriage Rate (Time frame: till 12 weeks of gestation) <br/ ><br>3. Endometrial thickness during stimulation (Time frame: during <br/ ><br>stimulation cycle designated as safety issue: No
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