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To explore the immunological basis in women with repeated IVF failure and to study the effect of fat emulsion on natural killer cells during IVF in these women

To investigate the role of Natural Killer cells in implantation failure and to study immunomodulatory effect of Intralipids in women with elevated uterine Natural Killer(uNK) cells in Fresh non-donor IVF cycles â?? A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019472
Enrollment
130
Registered
2019-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Intralipid (20%): Dose-18mg/ml of total blood volume corresponding to 4ml in 250 ml normal saline over 30-60 minutes.Frequency-First dose on the day of oocyte retrieval, second dose wit

Sponsors

Indian Council of Medical Research
Lead Sponsor
All India Institute of Medical Sciences
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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 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

Exclusion criteria

Exclusion criteria: 1. Donor oocyte IVF/ICSI 2. Donor Semen IVF 3. Poor Endometrium 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

Design outcomes

Primary

MeasureTime frame
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, clinical pregnancy rate and ongoing pregnancy rateTimepoint: First trimester at 6 weeks and 12 weeks—

Secondary

MeasureTime frame
1.Reference range of uNK and peripheral blood NK(pNK) cell percentage from fertile women 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/ICSITimepoint: prior to IVF—

Countries

India

Contacts

Public ContactDr Yogita Dogra

AIIMS

dryogitadogra@gmail.com7018955300

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026