Cabergoline and Coasting to Prevent OHSS

Not Applicable

Completed

• Conditions: OHSS
• Interventions: Procedure: ICSI

• Registration Number: NCT01984320
• Lead Sponsor: Cairo University

Brief Summary

The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.

Detailed Description

To randomly compare three study groups under a high risk of developing OHSS to one of three arms of management, either coasting for 1 to 3 days or receiving cabergoline for 8 days or coasting for 1 day plus receiving cabergoline for 8 days in ICSI patients following the long luteal GnRH agonist protocol.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. Age <or= 35, BMI <or= 30
2. Long protocol GnRH agonist cycles
3. Estradiol level on day of HCG >or= 3500 pg/ml
4. Retrieving more than 15 oocytes

Exclusion Criteria

1. Male factor
2. Uterine factor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coasting and Cabergoline	ICSI	In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 day plus receiving 0.25 mg of cabergoline daily for 8 days from HCG triggering day to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.
Coasting	ICSI	In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 to 3 days until drop of estradiol to a safe level to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.
Cabergoline	ICSI	In their ICSI cycle patients will take 0.25 mg of cabergoline daily for 8 days from HCG triggering day to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.

Primary Outcome Measures

Name	Time	Method
Rate and degree of OHSS (composite outcome)	14 days	Symptoms of nausea, vomiting, shortness of breath, abdominal pain,abdominal distension. Ovarian size and fluid in douglas pouch by ultrasound. Haematocrit, total leucocytic count, creatinine and Estradiol level as biochemical markers. Early OHSS first 9 days after ovum pickup and late is after 9 days till 14 days (time of pregnancy test)

Secondary Outcome Measures

Name	Time	Method
Number of oocytes	1 day	Number of oocytes collected on the day of oocyte collection

Trial Locations

Locations (1)

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini); 🇪🇬 Cairo, Egypt