Does fat emulsion improves pregnancy outcome in women with repeated IVF failure ?
- Conditions
- Health Condition 1: O090- Supervision of pregnancy with history of infertility
- Registration Number
- CTRI/2019/01/017213
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
For Subjects -
1.History of two or more failed IVF/ICSI cycle.
2.Fresh IVF cycles
3.BMI â?? 19-30 kg/m2
4.Normal menstrual cycles
5.Normal ovarian reserve (AMH > 2ng/ml, FSH <9IU, AFC >8)
6.Factor of infertility â?? unexplained , tubal secondary to ectopic pregnancy and after clipping if hydrosalpinges
7.Normal uterine cavity, as assessed by hysteroscopy or 4D ultrasonography
8.Good quality embryos
9.Normal Partner Semen Analysis including DNA fragmentation index and Reactive oxygen species analysis
For Controls -
1.Volunteer
2.Regular menstrual cycles
3.No history of infertility
4.No hormonal treatment for past three months
1.Donor oocyte IVF/ICSI
2.Donor Semen IVF
3.Poor Endometrium <7mm
4.Polycystic ovary syndrome
5.OCP use in past three months
6.Previous history of hysteroscopic adhesiolysis
7.Severe Male factor infertility requiring surgical sperm retrieval
8.Moderate to severe Endometriosis
9.Abnormal parental karyotype
10.History of known immunological and medical disorders like SLE, Rheumatoid Arthritis, diabetes, congenital or acquired blood dyscrasias
11.Clinical or laboratory findings of congenital or acquired thrombophilia
12.Known history of allergic predisposition to soy products, egg products and lecithin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of Intralipid supplementation during IVF in women with two or more IVF/ICSI failure and increased uterine NK(uNK) cell percentage on reproductive outcome in terms of implantation rate and clinical pregnancy rateTimepoint: First trimester at 6 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Reference range of uNK and peripheral blood NK(pNK) cell percentage from fertile women <br/ ><br>2.Correlation between pNK and uNK cell levels in samples taken simultaneously in fertile women as well as women with previous two or more failed IVF/ICSI <br/ ><br>Timepoint: prior to IVF <br/ ><br>