NCT02701452: COAGO

Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response

Terminated NA Last updated 4 October 2019

What this trial tests

NA trial testing COAGO in Ovarian Hyperstimulation Syndrome in 1 participant. Terminated before completion.

Timeline

26 February 2016

Primary endpoint
1 January 2019

1 January 2019

Quick facts

Lead sponsor	University Hospital, Lille
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	1
Start date	26 February 2016
Primary completion	1 January 2019
Estimated completion	1 January 2019

Drugs / interventions tested

• COAGO

Conditions studied

• Ovarian Hyperstimulation Syndrome — all drugs for Ovarian Hyperstimulation Syndrome →
• Hypercoagulability — all drugs for Hypercoagulability →

Sponsor

University Hospital, Lille

Who can join

Adults 18 to 43, female only, with Ovarian Hyperstimulation Syndrome or Hypercoagulability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In the literature, the risk of moderate to severe OHSS is 3 to 6% and reaches 31% in high risk populations 9 days after oocyte triggering with hCG. Many studies report no or a markedly decreased risk of OHSS after triggering ovulation with a GnRH agonist. However, criteria to define OHSS are rarely explained and OHSS itself is not thoroughly asserted. It is well known that OHSS is associated with hypercoagulability. However, no study after triggering with a GnRH agonist assessed haemostasis in these high-risk patients with high circulating estradiol levels.

Study design, size, duration: In a French academic reproductive medicine centre, a systematic prospective observational follow-up of all patients triggered by GnRH agonist for excessive follicular response will be conducted. Participants/materials, setting, methods: All patients undergoing antagonist protocol and at high risk of OHSS (estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering) will be triggered by GnRH agonist. No luteal phase support and a "freeze-all" strategy will be performed. On the day of oocyte retrieval (T0), at 48h (T1) and at day 7 (T2), OHSS and hypercoagulability will be systematically assessed. Haemostasis data will be compared to the initial status of each patient.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.