Effect of Intralipid Infusion in Patients With Recurrent Implantation Failure

NCT02865785 | Unknown Phase 1 DMC

• 1 other identifier: Intralipid-RIF
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of present study is to evaluate the effect of intralipid 20% infusion, once between days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy test on clinical pregnancy rates in women with unexplained recurrent implantation failure.

Conditions

Subfertility

Keywords

recurrent implantation failure; intralipid; uterine natural killer cells

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  38 gestational weeks

Secondary Outcomes (2)

• Clinical pregnancy rate

  6 gestational weeks

• Chemical pregnancy rate

  6 gestational weeks

Study Arms (2)

Study Group

ACTIVE COMPARATOR

This group will include 160 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of intralipid 20% (100 mL of intralipid 20% diluted in 250 mL sterile i.v. saline administered i.v. over two hours), once between days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy test.

Drug: Intralipid 20%

Placebo Group

PLACEBO COMPARATOR

This group will include 160 women with unexplained recurrent implantation failure undergoing a trial of IVF/ICSI. This group will receive intravenous infusion of placebo, once between days 4 and 9 of the ovarian stimulation, and again within 7 days of a positive pregnancy test.

Drug: Placebo

Interventions

Intralipid 20% DRUG

intralipid D4-9 of induction ovulation to be repeated within 7 days of positive pregnancy test.

Also known as: lipofundin 20%

Study Group

Placebo DRUG

saline infusion D4-9 of induction of ovulation to be repeated within 7 days of positive pregnancy test.

Also known as: saline 0.9%

Placebo Group

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-38 years of age.
• Recurrent implantation failure, defined as failure to achieve a recognizable intrauterine gestational sac by ultrasonography after transfer of at least four good-quality embryos in a minimum of three fresh or frozen IVF cycles (Coughlan et al, 2014).
• Good-quality embryos will be defined as those characterized by absence of multinucleated blastomeres, four or five blastomeres on day 2, seven or more cells on day 3, and ≤ 20% anucleated fragments (Van Royen et al, 1999).
• Normal transvaginal ultrasonography
• Normal office hysteroscopy.
• Normal hysterosalpingography.
• Absence of any structural pathological findings in laparoscopy.
• Normal male and female karyotyping.
• Normal endocrinological profile during ovarian stimulation
• Normal anti-cardiolipin antibody IgG, IgM and lupus anticoagulant.
• Normal thrombophilia screen in the form of protein C, protein S, anti thrombin III, factor V mutations and factor V leiden.
• Elevated uterine natural killer cells (uNK) density in luteal phase endometrial biopsy, defined as ≥ 5% CD16+ CD56+ cells in the stroma underlying the luminal epithelium (Tang et al, 2013; Quenby et al, 2005).
• Normal parameters of male semen analysis according to WHO criteria 2010.
• Written and signed informed consent by the patient to participate in the study.

You may not qualify if:

• Age more than 38 years.
• Less than 3 failed IVF cycles.
• Poor embryo quality in previous IVF trials.
• Abnormal ultrasonographic finding, e.g. endometrial polyps, fibroids or ovarian cysts.
• Abnormal hysteroscopic finding, e.g. endometrial polyps, endometrial hyperplasia or fibroid.
• Abnormal hysterosalpingographic finding, e.g. hydrosalpinx or peritoneal adhesions.
• Abnormal male or female karyotyping.
• Abnormal endocrinological profile during ovarian stimulation, e.g. hyperprolactinemia
• Expected poor ovarian responders according to Bologna criteria (Ferraretti et al, 2011), i.e. presence of at least two of the following three features:
• Presence of risk factor for poor ovarian response (POR) represented by advanced maternal age (≥ 40 years) or any other genetic or acquired conditions possibly linked to a reduced amount of resting follicles.
• A previous POR, represented by a cycle cancelled (following the development of less than three growing follicles) or the collection of less than four oocytes in response to an ovarian stimulation protocol of at least 150 IU FSH per day.
• An abnormal ovarian reserve test (i.e. AFC \< 5-7 follicles or AMH \< 0.5-1.1 ng/ml).
• Positive anticardiolipin antibodies or lupus anticoagulant.
• Positive thrombophilia screen.
• Normal uterine natural killer cells (uNK) density in luteal phase endometrial biopsy, defined as \< 5% CD16+ CD56+ cells in the stroma underlying the luminal epithelium (Tang et al, 2013; Quenby et al, 2005).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

AinShams Maternity Hospital

Cairo, Cairo Governorate, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Khaled Afifi, MBBCH

  Resident of O&G

  STUDY DIRECTOR

Central Study Contacts

Khaled Afifi, MBBCH

CONTACT

01009981222; DrKhaledAfifi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 12, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 12, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)