Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

N/AUnknownNCT02022228

Chenshiling200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Infertility and at High Risk of OHSS

Interventions

Eligibility

Sex: FEMALEMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

clinical pregnancy rate per transfer cycle

Time frame: 1month post embryo transfer

numbers of patients having OHSS

Time frame: 2 weeks post trigger with dual GnRHa

oocyte yield

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.

Time frame: oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG)

Oocyte maturity

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).

Time frame: 24 hours post oocyte retrieval day

Secondary Outcomes

serum luteinizing hormone level 12 hours post trigger

Time frame: 12 hours post trigger

serum hCG level 12 hours post trigger

Time frame: 12 hours post trigger

fertilization rate

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).

Time frame: 48 hours post IVF/ICSI

implantation rate

Time frame: 1 month post embryo transfer