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

Ovarian Hyperstimulation Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02701452
• Other study ID #: 2014_08
• Secondary ID: 2015-A01291-48
• Status: Terminated
• Phase: N/A
• Start date: February 26, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: October 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Seventy-five patients will be required for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercoagulability
• Ovarian Hyperstimulation Syndrome
• Syndrome
• Thrombophilia

Intervention

Other:
• COAGO
blood samples for haemostasis and hormonal data

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	The day of oocyte retrieval (Time 0).
Secondary	Dosage of Prothrombin time		The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Secondary	Dosage of APTT		The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Secondary	Dosage of fibrinogen		The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Secondary	Dosage of von Willebrand factor antigen Antithrombin,		The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Secondary	Dosage of DDimères		The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Secondary	Dosage of oestradiol	To evaluate its decrease.	The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Secondary	Dosage of progesterone	To evaluate the quality of lutea and date of post punctures rules	The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
Secondary	Cumulative pregnancy rate after transfer of thawed embryos.		2 months after the transfer of the last thawed embryo
Secondary	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).	2 days after (T1) and 7 days after (T2) the oocyte retrieval