Clinical trial NCT02022228: Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility and at High Risk of OHSS
Keywords: Ovarian Hyperstimulation Syndrome
Luteinizing Hormone
Polycystic Ovarian Syndrome
Ovarian Yield
Ovarian Maturity
Gonadotropin Releasing Hormone Agonist
Human Chorionic Gonadotropin
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
name: Comprehensive Strategic Cooperation Project of Guangdong Province and Chinese Academy of Science
name: Guangzhou Science and Technology Program key projects
name: National Key Basic Research Development Plan of China
First posted: 2013-12-27
Enrollment: 200
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: clinical pregnancy rate per transfer cycle
timeFrame: 1month post embryo transfer
measure: numbers of patients having OHSS
timeFrame: 2 weeks post trigger with dual GnRHa
measure: oocyte yield
timeFrame: oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG)
measure: Oocyte maturity
timeFrame: 24 hours post oocyte retrieval day
Secondary outcomes:
measure: serum luteinizing hormone level 12 hours post trigger
timeFrame: 12 hours post trigger
measure: serum hCG level 12 hours post trigger
timeFrame: 12 hours post trigger
measure: fertilization rate
timeFrame: 48 hours post IVF/ICSI
measure: implantation rate
timeFrame: 1 month post embryo transfer
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Shi-Ling Chen, M.D., Ph.D.
role: STUDY_CHAIR
References: