NCT03503227

Brief Summary

This study is a prospective, double-blind, randomized controlled trial . It includes 250 infertile patients scheduled for ICSI cycle. The patients will be randomly allocated into two equal groups; daily oral low dose Acetylsalicylic acid and group B patients will receive daily oral low dose Acetylsalicylic acid and Low dose prednisolone. All 250 participants undergo similar ICSI cycles. Primary outcome is clinical pregnancy rate per cycle. Secondary outcomes include number of oocytes retrieved, fertilization rate, number of embryos, embryo quality, chemical pregnancy rate, twins rate and miscarriage rate per cycle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

April 2, 2018

Last Update Submit

April 2, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate per cycle.

    Detection of gestational sac , embryo pole and fetal pulsations by transvaginal ultrasound

    7 weeks

Secondary Outcomes (7)

  • number of oocytes retrieved per cycle.

    3 weeks

  • fertilization rate per cycle.

    3weeks

  • number of embryos per cycle.

    3weeks

  • embryo quality per cycle.

    3weeks

  • chemical pregnancy rate per cycle.

    5 weeks

  • +2 more secondary outcomes

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

Patients will receive daily oral low dose Acetylsalicylic acid (75 mg) starting day 20 of the previous cycle withGonadotrophin releasing hormone agonist (GnRH agonist)

Drug: Acetyl Salicylic acid

Aspirin and prednisolone

ACTIVE COMPARATOR

Patients will receive daily oral low dose Acetylsalicylic acid (75 mg) and Low dose prednisolone (10 mg/day) starting day 20 of the previous cycle withGonadotrophin releasing hormone agonist (GnRH agonist).

Drug: prednisoloneDrug: Acetyl Salicylic acid

Interventions

prednisoloneDRUG

daily oral low dose prednisolone (10 mg/day) :a glucocorticoid

Aspirin and prednisolone
Acetyl Salicylic acidDRUG

daily oral low dose Acetylsalicylic acid (75 mg) : Antiplatelet agent

AspirinAspirin and prednisolone

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women in reproductive age diagnosed with infertility for IVF/ICSI, female age (18- \<40 years, normal serum hormonal profile on day 3 of the cycle \[including estradiol (E2), FSH, LH, prolactin, thyroid stimulating hormone, normal uterine cavity diagnosed at hysteroscopy.

You may not qualify if:

  • Women with platelet dysfunction, thrombocytopenia, gastrointestinal ulcers, recurrent gastritis, Acetylsalicylic acid hypersensitivity, patients on corticosteroids will be excluded from the study.
  • Also women with known cause for recurrent miscarriage: antiphospholipid syndrome (positive anticardiolipin antibody or lupus anticoagulant on 2 separate occasions at least 6 weeks apart), thrombophilia (factor V Leiden mutation, activated protein C resistance (APCR) resistance, protein C or S deficiency, prothrombin gene mutation, antithrombin III deficiency), abnormal thyroid function tests, parental balanced translocation or uterine anomaly (known subseptate uterus or cervical weakness diagnosed at hysteroscopy).
  • Contraindications to steroid therapy: hypertension, diabetes, mental health problems or obesity with BMI \>35
  • Decline consent to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KasralainiH

Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Amira S Dieb, MD

    KasrAlainiH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ob/Gyn Lecturer

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 19, 2018

Study Start

April 23, 2018

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)