The Influence of Timing of Cabergoline Initiation on Prevention of OHSS

NCT ID: NCT02620605

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-20
• Study Completion Date: 2019-04-30

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 .

Conditions

Ovarian Hyperstimulation Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Late administration of Cabirgoline 0.5 mg

Cabergoline 0.5mg (Dostinex®, Pfizer Australia Pty Ltd ) administrated once daily started on day of HCG triggering and continued for 8 days.

Group Type: ACTIVE_COMPARATOR

Late Cabergoline 0.5mg

Intervention Type: DRUG

Cabergoline 0.5mg will be administrated once daily at day of HCG trigger and continued for 8days

Early administration of Cabirgoline 0.5mg

Cabergoline 0.5mg(Dostinex®, Pfizer Australia Pty Ltd ) once daily stared once patients fulfilling the inclusion criteria at any day of cycle and continued for 8 days post HCG trigger.

Group Type: EXPERIMENTAL

Early Cabergoline 0.5mg

Intervention Type: DRUG

Cabergoline 0.5mg will be administrated once daily when E2 is more than 4000pg/ml and /or more than 18 follicles of 11mm diameter or more are encountered at any day of the controlled ovarian hyper-stimulation and before HCG trigger to be continued for 8days after HCG trigger.

Interventions

Late Cabergoline 0.5mg

Cabergoline 0.5mg will be administrated once daily at day of HCG trigger and continued for 8days

Intervention Type: DRUG

Early Cabergoline 0.5mg

Cabergoline 0.5mg will be administrated once daily when E2 is more than 4000pg/ml and /or more than 18 follicles of 11mm diameter or more are encountered at any day of the controlled ovarian hyper-stimulation and before HCG trigger to be continued for 8days after HCG trigger.

Intervention Type: DRUG

Other Intervention Names

Dostenix (Dostinex®, Pfizer Australia Pty Ltd ); Dostinex (Dostinex®, Pfizer Australia Pty Ltd )

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mona M Shaban

OTHER

Sponsor Role: lead

Responsible Party

Mona M Shaban

Mona Mohamed shaban ,assistant professor MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mona M Shaban, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

IVF department in Kasr Alaini hospital,private IVF centre

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sherine H Gad Allah, MD

Role: CONTACT

sherinehosny@gmail.com

01097665573 ext. +2

mona M Shaban, MD

Role: CONTACT

monashaban75@yahoo.com

01001078586 ext. +2

Facility Contacts

Sherine H Gad Allah, MD

Role: primary

sherinehosny@gmail.com

01097665573 ext. +2

Other Identifiers

C123

Identifier Type: -

Identifier Source: org_study_id