Cabergoline and Coasting to Prevent OHSS

Cairo University (CU)

Status: Completed

Conditions: OHSS

Treatments: Procedure: ICSI

Study type: Interventional

Funder types: Other

Identifiers

NCT01984320

92013

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Coasting

Active Comparator group

Description:

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.

Treatment:

Procedure: ICSI

Cabergoline

Active Comparator group

Description:

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.

Treatment:

Procedure: ICSI

Coasting and Cabergoline

Active Comparator group

Description:

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.

Treatment:

Procedure: ICSI