- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02022228
Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome
Dual Trigger With GnRH Agonist and Human Chorionic Gonadotropin for Final Oocyte Maturation in Patients at High Risk of Ovarian Hyperstimulation Syndrome in GnRH Antagonist Protocol
Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk patients.
However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist.
Our aim is to study dual trigger with GnRH agonist and human chorionic gonadotropin (hCG) for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Recruiting
- Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with polycystic ovarian syndrome
- patients with polycystic ovarian morphology on ultrasound
- patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins
Exclusion Criteria:
- patients undergoing coasting
- patients with past ovarian surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.2mg triptorelin and 500 IU hCG
Patients were triggered with 0.2mg triptorelin and 500 IU hCG
|
0.2 mg triptorelin, ih
Other Names:
1000 IU hCG, im
500IU hCG, im
|
Experimental: 0.2mg triptorelin and 1000 IU hCG
Patients were triggered with 0.2mg triptorelin and 1000 IU hCG
|
0.2 mg triptorelin, ih
Other Names:
1000 IU hCG, im
500IU hCG, im
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
clinical pregnancy rate per transfer cycle
Time Frame: 1month post embryo transfer
|
1month post embryo transfer
|
|
numbers of patients having OHSS
Time Frame: 2 weeks post trigger with dual GnRHa
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2 weeks post trigger with dual GnRHa
|
|
oocyte yield
Time Frame: oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG)
|
Oocyte yield was defined as the ratio of the total number of collected oocytes to the number of follicles measuring ≥10 mm on the day of oocyte retrieval.
|
oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG)
|
Oocyte maturity
Time Frame: 24 hours post oocyte retrieval day
|
Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in the patients undergoing with intracytoplasmic sperm injection (ICSI).
|
24 hours post oocyte retrieval day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum luteinizing hormone level 12 hours post trigger
Time Frame: 12 hours post trigger
|
12 hours post trigger
|
|
serum hCG level 12 hours post trigger
Time Frame: 12 hours post trigger
|
12 hours post trigger
|
|
fertilization rate
Time Frame: 48 hours post IVF/ICSI
|
Fertilization rate was defined as the ratio of normal fertilized oocytes (2PNs) to the number of oocytes used for fertilization (i.e. the denominator in IVF in calculating fertilization rate is all oocytes recovered, but in ICSI it is calculated using only the number of MII oocytes).
|
48 hours post IVF/ICSI
|
implantation rate
Time Frame: 1 month post embryo transfer
|
1 month post embryo transfer
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Shi-Ling Chen, M.D., Ph.D., Nanfang Hospital of Southern Medical University
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
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Endocrine System Diseases
- Disease
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Syndrome
- Infertility
- Ovarian Hyperstimulation Syndrome
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Luteolytic Agents
- Triptorelin Pamoate
Other Study ID Numbers
- Dual Trigger
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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