Clinical trial NCT02620605: The Influence of Timing of Cabergoline Initiation on Prevention of OHSS
Official title: The Influence of Timing of Cabergoline Initiation on Prevention of Ovarian Hyper Stimulation Syndrome in Patients Undergoing Intra Cytoplasmic Sperm Injection .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: Cabergoline
Ovarian Hyper Stimulation Syndrome (OHSS)
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 75
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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.

Group B: will receive cabergoline 0.5 mg/day once the criteria of inclusion criteria is fulfilled and continued till the day of human chorionic gonadotropin (HCG ) trigger and continued 8 days more from day of trigger .

Eligibility criteria: Inclusion Criteria:

* Female less than 35 years under going Intra cytoplasmic sperm injection cycle for infertility (tubal factor or un explained infertility).
* 18 or more oocyte 11 mm in diameter and/or E2 is more than 4000 pg/ml at any day of the stimulation cycle before or at HCG trigger

Exclusion Criteria:

* patient with one ovary
* patients already receiving cabergoline treatment
* Severe Male factor infertility.
* Thyroid dysfunction.

Primary outcomes:
measure: Occurrence and severity of OHSS
timeFrame: 2 to 4weeks after trigger
Secondary outcomes:
measure: Number of M|| oocytes.
timeFrame: maximum one day after ovum pick up
measure: Fertilization rate.
timeFrame: 16 to 19 hours after ICSI
measure: Clinical Pregnancy rate
timeFrame: 2 to 4 weeks after positive pregnancy test
measure: implantation rate
timeFrame: 2 to 4 weeks after positive pregnancy test
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: IVF department in Kasr Alaini hospital,private IVF centre
Study officials:
name: Mona M Shaban, MD
role: PRINCIPAL_INVESTIGATOR
References: