Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response - Clinical Trial for Ovarian Hyperstimulation Syndrome | NCT02701452

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

COAGO

About this trial

This is an interventional diagnostic trial for Ovarian Hyperstimulation Syndrome focused on measuring GnRH agonist triggering

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering and antagonist protocol

Exclusion Criteria:

agonist protocol no health assurance estradiol level < 3000 pg/mL and less than 20 follicles ≥ 11mm on the day of triggering

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COAGO

Arm Description

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) were triggered by GnRH agonist.

Outcomes

Primary Outcome Measures

Number of patients with the presence of moderate to severe OHSS

The OHSS defined by the classification of the "practice committee of the American Society for Reproductive Medicine" following biological, clinical and ultrasonographical criteria (composite): Clinical: weight, waist circumference, dyspnea, EVA, diuresis Organic: NFS, electrolytes, creatinine, urea, AST / ALT, albumin, serum protein Ultrasound: ovarian size, quantification of ascites (Douglas, Morrison, parieto-colic gutters, vesico-uterine space).

Secondary Outcome Measures

Dosage of Prothrombin time

Dosage of APTT

Dosage of fibrinogen

Dosage of von Willebrand factor antigen Antithrombin,

Dosage of DDimères

Dosage of oestradiol

To evaluate its decrease.

Dosage of progesterone

To evaluate the quality of lutea and date of post punctures rules

Cumulative pregnancy rate after transfer of thawed embryos.

Number of patients with the presence of moderate to severe OHSS

The OHSS defined by the classification of the "practice committee of the American Society for Reproductive Medicine" following biological, clinical and ultrasonographical criteria (composite): Clinical: weight, waist circumference, dyspnea, EVA, diuresis Organic: NFS, electrolytes, creatinine, urea, AST / ALT, albumin, serum protein Ultrasound: ovarian size, quantification of ascites (Douglas, Morrison, parieto-colic gutters, vesico-uterine space).

Full Information

NCT ID

NCT02701452

First Posted

February 25, 2016

Last Updated

October 1, 2019

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT02701452

Brief Title

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

Acronym

COAGO

Official Title

Prevalence of Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response After Ovarian Stimulation With a GnRH Antagonist

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Terminated

Study Start Date

February 26, 2016 (Actual)

Primary Completion Date

January 1, 2019 (Actual)

Study Completion Date

January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

Detailed Description

Seventy-five patients will be required for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Hyperstimulation Syndrome, Hypercoagulability

Keywords

GnRH agonist triggering

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

COAGO

Arm Type

Experimental

Arm Description

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) were triggered by GnRH agonist.

Intervention Type

Other

Intervention Name(s)

COAGO

Intervention Description

blood samples for haemostasis and hormonal data

Primary Outcome Measure Information:

Title

Number of patients with the presence of moderate to severe OHSS

Description

The OHSS defined by the classification of the "practice committee of the American Society for Reproductive Medicine" following biological, clinical and ultrasonographical criteria (composite): Clinical: weight, waist circumference, dyspnea, EVA, diuresis Organic: NFS, electrolytes, creatinine, urea, AST / ALT, albumin, serum protein Ultrasound: ovarian size, quantification of ascites (Douglas, Morrison, parieto-colic gutters, vesico-uterine space).

Time Frame

The day of oocyte retrieval (Time 0).

Secondary Outcome Measure Information:

Title

Dosage of Prothrombin time

Time Frame