NCT02022241

Repeated Injection of GnRH Agonist for Triggering Final Oocyte Maturation in Patients at High Risk of Ovarian Hyperstimulation Syndrome in GnRH Antagonist Protocol

Status unknown NA Last updated 20 December 2013

What this trial tests

NA trial testing triptorelin in Infertility and at High Risk of OHSS in 80 participants. Status unknown.

Timeline

1 July 2012

Primary endpoint
1 December 2015

1 June 2016

Quick facts

Lead sponsor	Chenshiling
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	1 July 2012
Primary completion	1 December 2015
Estimated completion	1 June 2016
Sites	1 location across China

Drugs / interventions tested

• triptorelin (triptorelin) — full drug profile →

Conditions studied

• Infertility and at High Risk of OHSS — all drugs for Infertility and at High Risk of OHSS →

Sponsor

Chenshiling

Who can join

Under 40, female only, with Infertility and at High Risk of OHSS. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• clinical pregnancy rate per transfer cycle
  Time frame: 1month post embryo transfer
• numbers of patients having OHSS
  Time frame: 2 weeks post trigger with repeated GnRHa
• oocyte yield
  Time frame: oocyte retrieval day (34 to 38 hours post the first trigger with GnRHa)
  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 ICSI.

Sponsor's own description

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 repeated injection of GnRH agonist for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.