CClinicalTrials.gg
Status unknownNCT02022228Updated Dec 27, 2013

Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

An interventional study of triptorelin and hCG in Infertility and at High Risk of OHSS, sponsored by Chenshiling. Status unknown at 1 site in China. Open to female participants aged Up to 40 Years. Per ClinicalTrials.gov, last updated 2013-12-27.

Sponsored by Chenshiling · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
Up to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • 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
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 200 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Chenshiling is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 40 Years
Sexes eligible
Female
Accepts 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

Exclusion Criteria:

  • patients undergoing coasting
  • patients with past ovarian surgery
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    0.2mg triptorelin and 500 IU hCG

    Patients were triggered with 0.2mg triptorelin and 500 IU hCG

    Drug: triptorelin · Drug: hCG

  • Experimental
    0.2mg triptorelin and 1000 IU hCG

    Patients were triggered with 0.2mg triptorelin and 1000 IU hCG

    Drug: triptorelin · Drug: hCG

Interventions

  • Drugtriptorelin

    0.2 mg triptorelin, ih

    Also known as: triptorelin: Diphereline

  • DrughCG

    1000 IU hCG, im

  • DrughCG

    500IU hCG, im

06

What researchers measure

Primary outcomes

  1. clinical pregnancy rate per transfer cycle

    Time frame: 1month post embryo transfer

  2. numbers of patients having OHSS

    Time frame: 2 weeks post trigger with dual GnRHa

  3. 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)

  4. 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

  1. serum luteinizing hormone level 12 hours post trigger

    Time frame: 12 hours post trigger

  2. serum hCG level 12 hours post trigger

    Time frame: 12 hours post trigger

  3. 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

  4. implantation rate

    Time frame: 1 month post embryo transfer

07

Study locations

1 of 1 sites recruiting
  • Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong 510515, China
    • Shi-Ling Chen, M.D., Ph.D. · Contact · chensl_92@163.com · +86-20-62787604
    • Shi-Ling Chen, M.D., Ph.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02022228
Lead sponsor
Chenshiling
Collaborators
National Natural Science Foundation of China, Comprehensive Strategic Cooperation Project of Guangdong Province and Chinese Academy of Science, Guangzhou Science and Technology Program key projects, National Key Basic Research Development Plan of China
Responsible party
Chenshiling (Professor, M.D., Ph.D., Nanfang Hospital, Southern Medical University) — Sponsor-investigator
First posted
Dec 27, 2013
Start date
Jul 2012
Primary completion
Dec 2015 (estimated)
Completion
Jun 2016 (estimated)
Last update
Dec 27, 2013

Study contacts

Shi-Ling Chen, M.D., Ph.D.
Contact
chensl_92@163.com
+86-20-62787604
Shi-Ling Chen, M.D., Ph.D.
study chair · Nanfang Hospital, Southern Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion