Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?
Primary Purpose
Ovarian Hyperstimulation Syndrome
Status
Terminated
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Triptorelin 0.2 mg
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome focused on measuring OVULATION INDUCTION
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- IVF Unit, Elisha Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OHSS high risk patients
Arm Description
Triptorelin 0.2 mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta.
Full Information
NCT ID
NCT01714648
First Posted
October 20, 2012
Last Updated
August 3, 2015
Sponsor
Elisha Hospital
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01714648
Brief Title
Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?
Official Title
An Uncontrolled, Open-label Feasibility Study to Demonstrate That a GnRH Agonist (Decapeptyl) Can be Safely Administered to Trigger Final Oocyte Maturation in High Responder Patients to Mitigate the Risk of OHSS
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Elisha Hospital
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Administration of hCG (10.000 or 5.000 IU) is essential in IVF protocols to trigger final oocyte maturation after ovarian stimulation. In high responder patients with potential risk of developing OHSS, hCG is usually withheld and the treatment cycle is cancelled without obtaining (cryopreserved) embryos for replacement.
An alternative approach to trigger final oocyte maturation is to administer a GnRH agonist instead of hCG. This method is not possible following a long GnRH agonist protocol which causes down-regulation of the GnRH receptor. However, following GnRH antagonist treatment the GnRH receptor remains receptive to competitive binding by a GnRH agonist.
It has been well-described in earlier IVF trials that a bolus of GnRH agonist will displace the GnRH antagonist from the GnRH receptors in the pituitary inducing an endogenous LH (and FSH) surge resulting in the maturation of oocytes and good quality embryos. In addition, the risk of moderate-to-severe ovarian hyperstimulation syndrome (OHSS) becomes minimal due to the rapid demise of the corpora lutea. Following luteolysis, fresh embryo transfer would require alternative luteal phase support to secure good clinical outcome. Alternatively, good quality embryos obtained after GnRH agonist triggering can be cryopreserved and replaced in following frozen-thawn embryo transfer (FTET) cycles. Thus, also eliminating late onset OHSS due to pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
OVULATION INDUCTION
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OHSS high risk patients
Arm Type
Experimental
Arm Description
Triptorelin 0.2 mg
Intervention Type
Drug
Intervention Name(s)
Triptorelin 0.2 mg
Other Intervention Name(s)
Decapeptyl 0.2 mg
Intervention Description
A single bolus of 0.2 mg triptorelin given 34-36 hours before oocyte retrieval.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety: The adverse event is the development of OHSS following oocyte retrieval.
Description
OHSS usually occurs a few days following oocyte retrieval, and is not a threat once menses start.
Time Frame
12 day from GnRH agonist trigger day.
Secondary Outcome Measure Information:
Title
Ongoing pregnancies following FTET cycles of cryopreserved embryos obtained following one treatment cycle of follitropin beta.
Time Frame
One month from embryo transfer date
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahar Kol, MD
Organizational Affiliation
Elisha Hospital, Haifa, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVF Unit, Elisha Hospital
City
Haifa
ZIP/Postal Code
31064
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome?
We'll reach out to this number within 24 hrs