Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS)

Eugonia

Status: Unknown

Conditions: Ovarian Hyperstimulation Syndrome

Treatments: Drug: cetrorelix (cetrotide); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02392520

luteal antag OHSS RCT

Details and patient eligibility

About

The study aims to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment in IVF patients who develop severe early ovarian hyperstimulation syndrome and have all their embryos cryopreserved.

Full description

GnRH antagonist administration in the luteal phase has been proposed as a strategy for the treatment of established severe early OHSS, causing rapid regression of the syndrome on an outpatient basis. The approach has been described as tertiary OHSS prevention, thereby complementing the primary prevention (GnRH antagonist protocol) and secondary prevention (GnRH agonist trigger) that constitute the OHSS-free clinic concept. No randomized controlled trials (RCT) exist to date comparing luteal GnRH antagonist administration versus conventional treatment.

The aim of the present study is to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment with primary outcome time to severe OHSS regression, in IVF patients who develop severe early OHSS and have all their embryos cryopreserved.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women with established severe early OHSS.

• Criteria for the diagnosis of severe OHSS require:

  • the presence of moderate (or higher) ascites and at least two of the following:

    • enlarged ovaries (>100 mm maximal diameter),
    • haematocrit (Ht) >45%,
    • white blood cell count (WBC) >15,000/mm3.

Exclusion criteria

• Women not fulfilling the above criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Antagonist

Experimental group

Description:

0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis

Treatment:

Drug: cetrorelix (cetrotide)

Conventional

Placebo Comparator group

Description:

Women with severe early OHSS will be treated with conventional treatment, such as intravenous albumin administration, paracentesis of ascitic fluid, either on an outpatient or inpatient basis.

Treatment:

Drug: Placebo