Repeated Injection of GnRH Agonist to Reduce Ovarian Hyperstimulation Syndrome

NCT02022241 | Unknown

• 1 other identifier: Repeated GnRHa trigger
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Infertility and at High Risk of OHSS

Keywords

Ovarian Hyperstimulation Syndrome; Luteinizing Hormone; Polycystic Ovarian Syndrome; Ovarian Yield; Ovarian Maturity

Outcome Measures

Primary Outcomes (4)

• clinical pregnancy rate per transfer cycle

  1month post embryo transfer

• numbers of patients having OHSS

  2 weeks post trigger with repeated 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.

  oocyte retrieval day (34 to 38 hours post the first trigger with GnRHa)

• 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 ICSI.

  24 hours post oocyte retrieval day

Secondary Outcomes (4)

• serum luteinizing hormone level 12 hours post first trigger

  12 hours post trigger with the first injection of GnRHa

• serum luteinizing hormone level 24 hours post first trigger

  24 hours post the first injection of GnRHa

• fertilization rate

  48 hours post IVF/ICSI

• implantation rate

  1 month post embryo transfer

Study Arms (1)

Repeated GnRHa

EXPERIMENTAL

Patients were triggered with repeated GnRHa

Drug: triptorelin

Interventions

triptorelin DRUG

0.2 mg, ih, at night and 0.2 mg, ih, 12 hours later when at least one of the following criteria was reached: (i) serum E2 ≥3500 pg/ml, (ii) ≥18 follicles measuring ≥11 mm.

Also known as: Diphereline

Repeated GnRHa

Eligibility Criteria

• Age: Up to 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• patients undergoing coasting
• patients with past ovarian surgery

Sponsors & Collaborators

• Chenshiling: lead
• National Natural Science Foundation of China: collaborator
• Comprehensive Strategic Cooperation Project of Guangdong Province and Chinese Academy of Science: collaborator
• Guangzhou Science and Technology Program key projects: collaborator
• National Key Basic Research Development Plan of China: collaborator

Study Sites (1)

Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Infertility; Ovarian Hyperstimulation Syndrome; Polycystic Ovary Syndrome

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gonadal Disorders; Endocrine System Diseases; Ovarian Cysts; Cysts; Neoplasms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Shi-Ling Chen, M.D., Ph.D.

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

• Xin Chen, M.D., Ph.D.

  Nanfang Hospital, Southern Medical University

  STUDY DIRECTOR

Central Study Contacts

Shi-Ling Chen, M.D., Ph.D.

CONTACT

+86-20-62787604; chensl_92@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, M.D., Ph.D.

Study Record Dates

• First Submitted: December 15, 2013
• First Posted: December 27, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: December 27, 2013

Record last verified: 2013-12

Locations

CN (1)