Preventive Application of GnRH Antagonist on Early OHSS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Hyperstimulation Syndrome GnRH Antagonist Aspirin Vascular Endothelial Growth Factor Pigment Epithelium Derived Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GnRH antagonist

Vitamin C (1 tablet daily) as placebo of aspirin GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days

Group Type EXPERIMENTAL

GnRH antagonist

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days

Interventions

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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

Intervention Type DRUG

aspirin

aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days

Intervention Type DRUG

Other Intervention Names

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Vitamin C platelet saline as placebo of GnRH antagonist

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No