Clinical Trial: The Influence of Timing of Cabergoline Initiation on Prevention of OHSS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Influence of Timing of Cabergoline Initiation on Prevention of Ovarian Hyper Stimulation Syndrome in Patients Undergoing Intra Cytoplasmic Sperm Injection .

Brief Summary: Study the effect of early cabergoline administration in prevention of occurrence or decreasing the severity of OHSS in patients undergoing intra cytoplasmic sperm injection.And its effect on oocyte maturation,fertilization and pregnancy rate..

Detailed Summary:

Patients less than 35years undergoing Intra Cytoplasmic Sperm Injection for infertility scheduled for gonadotropin releasing hormone agonist long protocol of ovarian stimulation.

All patient will receive combined oral contraceptive pills (Gynera, Schering-plow: plough) starting from day 5 of cycle that precedes the stimulated cycle .On day 21 of that cycle all patients will start to receive Gonadotrophin releasing hormone agonist in the form of (decapeptyl 0.1 sc daily and continued till the day of HCG administration).

To ensure that all patients are completely down regulated and desensitized ,trans-vaginal ultrasound will be performed at day 2-3 of menses of stimulated cycle to ensure endometrial thickness less than 5 mm and no ovarian cysts.Also serum E2 level is less than 50 pg/ml.

Then all patients will start to receive Gonadotrophin ( HMG) (Menogon, ferring pharmaceuticals, Germany) 225 IU (international unit) Intramuscular Injection daily,with continuous scheduled follow up of ovarian response by serial trans -vaginal US to assess follicular growth together will serial serum E2 starting from day 6 of cycle and onwards.With adjustments of gonadotropin dose and monitoring frequency based on patient response.

During follow up once the recruited patients fulfilling the inclusion criteria (serum E2 equal or more than 4000 pg/ml and /or 18 or more follicles of 11 mm diameter or more at any day of stimulation),they will be allocated randomly by computer generated cards and assigned by sealed envelopes by the treating doctor at the outpatient clinic.

Group A : will receive cabergoline 0.5 mg/day for 8 days, starting in the day of HCG (human chorionic gonadotropin ) injection. Sponsor: Mona M Shaban

Current Primary Outcome: Occurrence and severity of OHSS [ Time Frame: 2 to 4weeks after trigger ]

either early or late OHSS (early OHSS is the occurrence within 9 days after OPU and occurrence after 10 days was classified as late OHSS.The severity of OHSS was graded according to the criteria of Navot et al. (1992). Moderate OHSS in particular is characterized by abdominal distension and discomfort, nausea±vomiting±diarrhoea, enlarged ovaries 5-12 cm and ultrasonographic evidence of ascites. Severe OHSS is characterized by variable ovarian enlargement; massive ascites±hydrothorax; breathing difficulties; haematocrit >45%; white blood cell count >15 000; oligouria; creatinine 1.0-1.5;liver dysfunction; and anasarca oedema.)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of M|| oocytes. [ Time Frame: maximum one day after ovum pick up ]
  • Fertilization rate. [ Time Frame: 16 to 19 hours after ICSI ]
    fertilization rate (the presence of two pronuclei (2PN) at the time of fertilization assessment, 16 to 19 hours after ICSI),
  • Clinical Pregnancy rate [ Time Frame: 2 to 4 weeks after positive pregnancy test ]
    Clinical pregnancy was considered to be the presence of a gestational sac with fetal heart activity.
  • implantation rate [ Time Frame: 2 to 4 weeks after positive pregnancy test ]
    implantation rate( the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred)


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: November 24, 2015
Date Started: December 2015
Date Completion: June 2017
Last Updated: February 21, 2017
Last Verified: February 2017