Infertility Clinical Trial
Official title:
The Value of Addition of Prednisolone to Acetylsalicylic Acid Prior to Embryo Transfer in Patients With First ICSI Cycles: A Randomized Controlled Trial
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.
This study is a prospective, randomized, controlled trial. Patients undergoing ICSI for their
first cycle are enrolled in this study. Participants are then randomized into two groups ;
group A patients will receive daily oral low dose Acetylsalicylic acid (75 mg) and group B
patients will receive daily oral low dose Acetylsalicylic acid (75 mg) and Low dose
prednisolone (10 mg/day).
Randomization will be done by withdrawing closed envelopes for each patient .
Inclusion criteria:
Women in reproductive age diagnosed with infertility for ICSI, female age (18- <40 years,
normal serum hormonal profile on day 3 of the cycle [including estradiol (E2), follicle
stimulating hormone (FSH), Luteinizing hormone (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,
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 Body mass index (BMI) >35
- Decline consent to randomization
Methodology in details:
All patients will be subjected to the following:
- -Informed consent after explaining the aim of the study, procedure and possible hazards.
- -History taking includes full obstetric history, medical and surgical history and
demographic distribution.
- Full physical examination. -
- -Ultrasound examination (2D): Transvaginal sonography (TVS) is done on day 2 to 5 to
assess antral follicle count (AFC), uterus and adnexa .
- -Each group will start intake of Acetyl-Salicylic Acid (ASA) or ASA with Prednisolone on
day 19th - 20th of the previous cycle and continue until confirmation of pregnancy by
detection of fetal heart activity on ultrasound.
- -Long protocol steps:
- Start from day 19th - 20th by GnRH agonist ;Triptorelin 0.1mg subcutaneous
(Decapeptyl, Ferring). -1st visit : after 2 weeks of start of GnRH agonist or day 2
of cycle, we confirm down regulation by a serum level of E2to be <50 pg/ml,
endometrial thickness <5mm, no ovarian cyst by ultrasound. Then we add
Gonadotropins as Intramuscular (I.M.) injections of 150-300 I.U. of highly purified
Human Menopausal Gonadotropins daily (Merional, 75 I.U. /vial, IBSA). The dose is
adjusted according to the age, BMI, AFC, serum levels of anti-mullerian hormone
(AMH), follicle stimulating hormone (FSH) and ovarian response.
- 2nd visit : on 6th - 7 th days of Gonadotrophins and then every other day to do
folliculometry by TVS and E2 level in serum.
- We do trigger by Human Chorionic Gonadotrophin (HCG)10000 IU I.M.(Pregnyl, Organon)
when at least 3 follicles reach 18mm in mean diameter or more and E2 level is less
than 2500 pg/ml. Ovum pickup is done 34 hours after HCG injection and embryo
transfer using Wallace catheter on day 2 to 3.
- -Luteal support: Natural Progesterone 400 mg 1x2, Folic acid once daily,
Amoxicillin-Clavulanic Acid 1gm 1x2x7 ,Progesterone 100mg I.M. daily for 10 days,
Acetylsalicylic Acid once daily
- -Quantitative ß- HCG in serum after 14 days of embryo transfer. -TVS to detect clinical
pregnancy at 6-7 weeks of gestation.
Primary outcome:
The primary outcome is clinical pregnancy rate per cycle.
Secondary outcome:
Secondary outcome measures are number of oocytes retrieved, fertilization rate, number of
embryos, embryo quality, chemical pregnancy rate, twins rate and miscarriage rate per cycle.
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