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Clinical Trials/NCT02022228
NCT02022228
Unknown
Not Applicable

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

Chenshiling1 site in 1 country200 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
hCG
Conditions
Infertility and at High Risk of OHSS
Sponsor
Chenshiling
Enrollment
200
Locations
1
Primary Endpoint
numbers of patients having OHSS
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
June 2016
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Chenshiling
Responsible Party
Sponsor Investigator
Principal Investigator

Chenshiling

Professor, M.D., Ph.D.

Nanfang Hospital, Southern Medical University

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

Arms & Interventions

0.2mg triptorelin and 1000 IU hCG

Patients were triggered with 0.2mg triptorelin and 1000 IU hCG

Intervention: hCG

0.2mg triptorelin and 500 IU hCG

Patients were triggered with 0.2mg triptorelin and 500 IU hCG

Intervention: triptorelin

0.2mg triptorelin and 500 IU hCG

Patients were triggered with 0.2mg triptorelin and 500 IU hCG

Intervention: hCG

0.2mg triptorelin and 1000 IU hCG

Patients were triggered with 0.2mg triptorelin and 1000 IU hCG

Intervention: triptorelin

Outcomes

Primary Outcomes

numbers of patients having OHSS

Time Frame: 2 weeks post trigger with dual GnRHa

clinical pregnancy rate per transfer cycle

Time Frame: 1month post embryo transfer

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 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).

Secondary Outcomes

  • serum hCG level 12 hours post trigger(12 hours post trigger)
  • fertilization rate(48 hours post IVF/ICSI)
  • implantation rate(1 month post embryo transfer)
  • serum luteinizing hormone level 12 hours post trigger(12 hours post trigger)

Study Sites (1)

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