Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03188471
Other study ID # antagonist
Secondary ID
Status Recruiting
Phase Phase 4
First received June 10, 2017
Last updated June 14, 2017
Start date January 2017
Est. completion date March 2018

Study information

Verified date June 2017
Source First Affiliated Hospital, Sun Yat-Sen University
Contact Canquan Zhou
Phone +86 20 87755766
Email zhoucanquan@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.


Description:

Ovarian hyperstimulation syndrome is an iatrogenic complication of controlled ovarian stimulation. Early ovarian hyperstimulation syndrome (OHSS) occurs during luteal phase of controlled ovarian stimulation within 9 days after human chorionic gonadotropin trigger and reflects an acute consequence of this hormone on the ovaries.Ovarian hyperstimulation syndrome prevention is a multistage process and more important than treatment.Recently the administration of GnRH antagonists during the luteal phase of in vitro fertilization cycles offers another therapeutic modality for patients with severe early OHSS.However, preventive administration of GnRH antagonist for high risk OHSS patients from the day of oocyte retrieval is not investigated. Besides, the relevant mechanism is not clear yet. Here we designed a prospective randomized study to investigate whether GnRH anatagonist treatment after oocyte retrieval is more effective in preventing early ovarian hyperstimulation syndrome development than traditional aspirin preventive administration in women at high risk for OHSS.


Recruitment information / eligibility

Status Recruiting
Enrollment 175
Est. completion date March 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- number of oocyte retrieval more than 25;

- estradiol level higher than 5000pg/mL on the day of human chorionic gonadotropin administration;

- clinical or ultrasonography proven ovarian hyperstimulation syndrome on the day of oocyte retrieval.

Exclusion Criteria:

- contraindications to GnRH antagonist;

- coasting or other preventive measures for managing ovarian hyperstimulation syndrome had been applied;

- GnRH agonist for trigger.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GnRH antagonist
GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days for high risk of ovarian hyper stimulation syndrome patients
aspirin
aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days

Locations

Country Name City State
China The First Affiliated Hospital of Sun Yatsen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of early ovarian hyperstimulation syndrome Incidence and severity of early ovarian hyperstimulation syndrome according to its classification up to 1 month
Secondary vascular endothelial growth factor level VEGF level up to 1 month
Secondary pigment epithelium derived factor level PEDF level up to 1 month
Secondary incidence of hydrothorax one criterion for evaluation of OHSS severity up to 1 month
Secondary incidence of liver dysfunction one criterion for evaluation of OHSS severity up to 1 month
Secondary incidence of renal dysfunction one criterion for evaluation of OHSS severity up to 1 month
Secondary incidence of electrolytic imbalance one criterion for evaluation of OHSS severity up to 1 month
Secondary incidence of hemoconcentration one criterion for evaluation of OHSS severity up to 1 month
Secondary incidence of elevated WBC one criterion for evaluation of OHSS severity up to 1 month
See also
  Status Clinical Trial Phase
Withdrawn NCT00617864 - The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome N/A
Withdrawn NCT01979341 - The Effect of a Dual Trigger on Intracytoplasmic Sperm Injection (ICSI) Reproductive Outcomes N/A
Completed NCT01427335 - Calcium for Prevention of Ovarian Hyperstimulation Syndrome Phase 3
Completed NCT01014104 - Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome Phase 1/Phase 2
Recruiting NCT00119925 - 'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists" N/A
Completed NCT06333691 - Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin N/A
Terminated NCT01714648 - Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome? Phase 4
Completed NCT01500863 - Endometrial Receptivity After GnRH Agonist Triggering Phase 4
Recruiting NCT00417144 - Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients Phase 4
Completed NCT03876145 - The Four Methods of Ovarian Stimulation in Patients With Polycystic Ovarian Syndrome N/A
Completed NCT05588635 - Association Between Live Birth Rate and Serum Progesterone During Hormonal Replacement Therapy
Not yet recruiting NCT02392520 - Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS) N/A
Completed NCT00665041 - Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome Phase 2
Completed NCT00835523 - Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist N/A
Active, not recruiting NCT05638529 - Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome Phase 4
Not yet recruiting NCT03071172 - Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ET Phase 3
Recruiting NCT02084940 - Long Acting GnRH Antagonist in PCOS Women Undergoing IVF N/A
Completed NCT01815138 - Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS Phase 4
Completed NCT00867659 - The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors N/A
Completed NCT01569256 - Ovarian Hyperstimulation Syndrome and Cabergoline N/A