Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?

NCT01714648 | Terminated Phase 4

• 2 other identifiers: MSD-ELISHA18328-086
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Ovarian hyperstimulation syndrome (OHSS) is a major complication of ovarian stimulation for IVF if hCG is used to trigger final oocyte maturation. The investigators propose that using GnRH agonist as a trigger will eliminate OHSS, even in high-risk patients.

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

OVULATION INDUCTION

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval.

  OHSS usually occurs a few days following oocyte retrieval, and is not a threat once menses start.

  12 day from GnRH agonist trigger day.

Secondary Outcomes (1)

• Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta.

  One month from embryo transfer date

Study Arms (1)

OHSS high risk patients

EXPERIMENTAL

Triptorelin 0.2 mg

Drug: Triptorelin 0.2 mg

Interventions

Triptorelin 0.2 mg DRUG

A single bolus of 0.2 mg triptorelin given 34-36 hours before oocyte retrieval.

Also known as: Decapeptyl 0.2 mg

OHSS high risk patients

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A female patient who needs IVF to become pregnant.
• Regular menstrual cycle.
• Antral follicular count (AFC) \> 18
• Following treatment with follitropin beta more than 18 follicles ≥ 11 mm will develop.

You may not qualify if:

• Hypersensitivity to the active substance or to any of the medications used.
• Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
• Pregnancy.
• Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
• Primary ovarian failure.
• Ovarian cysts or enlarged ovaries.
• A history of Ovarian Hyperstimulation Syndrome (OHSS).
• A previous COS cycle that resulted in more than 30 follicles \> 11 mm measured by ultrasound examination.
• Fibroid tumours of the uterus incompatible with pregnancy.
• Malformations of the reproductive organs incompatible with pregnancy

Sponsors & Collaborators

• Elisha Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

IVF Unit, Elisha Hospital

Haifa, Israel, 31064, Israel

Location

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

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

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

• Shahar Kol, MD

  Elisha Hospital, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2012
• First Posted: October 26, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 4, 2015

Record last verified: 2015-08

Locations

IL (1)