Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age20-35
SponsorTanta University

About this trial

Ovarian hyperstimulation syndrome (OHSS) is a serious iatrogenic complication of controlled ovarian stimulation of gonadotrophin-Stimulated ovarian cycles. It is theorized to manifest systemically as a result of vasoactive mediators like vascular endothelium growth factor (VEGF) being released from hyperstimulated ovaries. As a result, capillary permeability is increased which causes the extravasation of fluid from the intravascular compartment into the third space. The haemoconcentration which ensues results in complications such as hypercoagulability and reduced end organ perfusion.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18-38 years

Body mass index (calculated as weight in kilograms divided by the square of height in meters) < 30 kg/m2.

A long luteal protocol is used for ovarian stimulation.

Day 2 FSH <10 mIU/L and E2< 50 pg/ml

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coasting

    Procedure/Surgery

    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

    Drug

    Cabergoline is used to treat different types of medical problems that occur when too much of the hormone prolactin is produced. It can be used to treat certain menstrual problems, fertility problems in men and women, and pituitary prolactinomas

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Cabergoline groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Occurrence and severity of OHSS

The primary outcome of this study is the occurrence and severity of OHSS. OHSS was defined as abdominal pain and distention associated with nausea and vomiting and ovarian enlargement \> 8 cm. The severity of OHSS will be assessed (mild, moderate, severe, and clinical) according to the American Society for Reproductive Medicine guidelines

Time frame
1 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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