- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01347268
Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist
A Prospective Randomized Study Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist Administration in Patients at Risk for Severe OHSS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Elevated estradiol (E2) levels and multiple folliculogenesis predispose to development of ovarian hyperstimulation syndrome (OHSS). In patients with GnRH agonist protocol, both withdrawing GnRH agonist and GnRH antagonist administration are associated with a reduction in (E2) levels with subsequent decreasing the incidence and severity of OHSS. This work is to compare the clinical and endocrine outcome response of cycles in which GnRH agonist withdrawing with cycles in which the GnRH antagonist administration in patients at risk of severe OHSS.
Purpose: To compare the decreased levels of estradiol (E2), coasting days, severity of OHSS and pregnancy outcomes of cycles in which GnRH agonist withdrawing with cycles in which the GnRH antagonist administration in patients at risk of severe OHSS.
Methods: a prospective randomized study was designed to evaluate clinical and endocrine outcome in two different coasting protocols. Women (n=120) under controlled ovarian hyperstimulation with GnRH agonist protocol at the risk of OHSS (≧20 follicles >12 mm development with E2> 4000 pg/ml) randomized into two groups. Group I (n=60), withdrawing GnRH agonists and continued low dose r-FSH 75 IU. Group II (n=60), GnRH antagonist administration and continued low dose r-FSH 75 IU. When E2< 3000 pg/ml, hCG was given. Oocyte retrieval was performed 36 h after hCG administration. The primary outcome measures were the decreased levels of estradiol (E2) and the days of coasting. The secondary outcome measures were number of oocytes retrieved, pregnancy rate and the incidence of OHSS.
anticipated results: No significant differences were seen in the levels of estradiol (E2) decreased, the days of coasting, number of oocytes, pregnancy rate and the incidence of OHSS. GnRH antagonist is not necessary in coasting treatment while stop GnRH agonist.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jiann-Loung Hwang, MD
- Phone Number: 3879 886-2-28332211
- Email: m001015@ms.skh.org.tw
Study Contact Backup
- Name: Heng-Ju Chen, MD
- Phone Number: 3870 886-2-28332211
- Email: m004983@ms.skh.org.tw
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memerial Hospital
-
Contact:
- Jiann-Loung Hwang, MD
- Phone Number: 3879 886-2-28332211
- Email: m001015@ms.skh.org.tw
-
Contact:
- Heng-Ju Chen, MD
- Phone Number: 3870 886-2-28332211
- Email: m004983@ms.skh.orh.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- the risk of ovarian hyperstimulation syndrome
Exclusion Criteria:
- allergic to GnRH antagonist
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: withdrawing GnRH agonists
|
withdrawing GnRH agonists and continued low dose r-FSH 75 IU
|
Experimental: GnRH antagonist administration
|
GnRH antagonist administration and continued low dose r-FSH 75 IU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
decreased levels of estradiol (E2)
Time Frame: one year
|
one year
|
|
The days of coasting
Time Frame: one year
|
The interval between the day of starting intervention and the day of hCG administration
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pregnancy rate
Time Frame: one year
|
one year
|
number of oocytes retrieved
Time Frame: one year
|
one year
|
the incidencess of OHSS
Time Frame: one year
|
one year
|
Collaborators and Investigators
Investigators
- Study Chair: Jiann-Loung Hwang, MD, Shin-Kong Wu Ho-Su Memerial Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SKH-8302-100-DR-08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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