Overview

The Value of Prednisolone With Aspirin Before Embryo Transfer in Intracytoplasmic Sperm Injection (ICSI) Cycles

Status:
Completed
Trial end date:
2018-10-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kasr El Aini Hospital
Treatments:
Aspirin
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Salicylates
Salicylic Acid
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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