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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02022228
Enrollment
200
Registered
2013-12-27
Start date
2012-07-31
Completion date
2016-06-30
Last updated
2013-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGtriptorelin

0.2 mg triptorelin, ih

DRUGhCG

1000 IU hCG, im

Sponsors

National Natural Science Foundation of China
CollaboratorOTHER_GOV
Comprehensive Strategic Cooperation Project of Guangdong Province and Chinese Academy of Science
CollaboratorOTHER
Guangzhou Science and Technology Program key projects
CollaboratorOTHER
National Key Basic Research Development Plan of China
CollaboratorUNKNOWN
Chenshiling
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oocyte maturity24 hours post oocyte retrieval dayOocyte 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).
clinical pregnancy rate per transfer cycle1month post embryo transfer—
numbers of patients having OHSS2 weeks post trigger with dual GnRHa—
oocyte yieldoocyte 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.

Secondary

MeasureTime frameDescription
serum luteinizing hormone level 12 hours post trigger12 hours post trigger—
serum hCG level 12 hours post trigger12 hours post trigger—
fertilization rate48 hours post IVF/ICSIFertilization 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).
implantation rate1 month post embryo transfer—

Countries

China

Contacts

Primary ContactShi-Ling Chen, M.D., Ph.D.
chensl_92@163.com+86-20-62787604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026