Does Intralipid improve pregnancy outcomes in IVF? A Randomised Controlled Trial

Phase 2

Completed

• Conditions: Health Condition 1: null- Healthy women who have previous failed in vitro fertilisation

• Registration Number: CTRI/2018/06/014451
• Lead Sponsor: All India Institute of Medical Sciences Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-05-11
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 102

Inclusion Criteria

1. History of one or more previously failed IVF/ICSI cycle.

2. Age 25 to 40 years

3. BMI in range of 20 to 32

4. Normal hormonal profile as assessed by DAY 2 FSH, LH, TSH, Prolactin, and AMH

5. Normal uterine cavity, as assessed by hysteroscopy or 3D ultrasonography.

6. Written consent to participate in trial

Exclusion Criteria

1. Women with obvious anatomical causes for implantation failure like fibroids, abnormal hysteroscopy or ultrasonography findings

2. Donor oocyte IVF / ICSI

3. Age more than 40 years

4. Abnormal parental karyotype

5. BMI more than 27

6. Poor quality embryos as graded by SART morphological grade

7. Immunological and medical comorbidities like connective tissue disorders, diabetes, congenital or acquired blood dyscrasias

8. Clinical or laboratory findings of congenital or acquired thrombophilia.

9. Severe male factor infertility requiring surgical sperm retrievals.

10. Known history of allergic predisposition with known or possible allergy to soy products, lecithin , egg products

11. Mental illness which renders the patient unable to understand the nature of the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To measure and compare biochemical pregnancy rate per cycle of embryo transfer (serum beta HCG of100 IU) in women who receive intravenous intralipid prior to and on day of embryo transfer versus women who receive placebo <br/ ><br> <br/ ><br>2. To assess and compare clinical pregnancy rate (USG shows fetal cardiac activity) in women who receive intravenous intralipid prior to and on day of embryo transfer versus women who receive placebo. <br/ ><br> <br/ ><br>Timepoint: 1. 16 days after embryo transfer <br/ ><br>2. 6 weeks after embryo transfer

Secondary Outcome Measures

Name	Time	Method
To measure and compare ongoing pregnancy rate and live birth rate in women who receive intravenous intralipid prior to and on day of embryo transfer versus women who receive placebo. <br/ ><br>Timepoint: 16 weeks of gestation