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Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
GnRH agonist trigger
hCG trigger
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

35 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • IVF patients with at least 4 consecutive failures.
  • On trigger day, no more than 10 follicles of 12 mm and up

Exclusion Criteria:

  • History of moderate or severe OHSS.

Sites / Locations

  • IVF Unit, Rambam medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

hCG trigger

GnRH agonist trigger

Arm Description

Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.

ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.

Outcomes

Primary Outcome Measures

Fetal Heart Activity 1 Month After Oocyte Retrieval
Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval

Secondary Outcome Measures

Patients Comfort During the Luteal Phase

Full Information

First Posted
January 27, 2014
Last Updated
May 20, 2015
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02048891
Brief Title
Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given. The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hCG trigger
Arm Type
Active Comparator
Arm Description
Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.
Arm Title
GnRH agonist trigger
Arm Type
Experimental
Arm Description
ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
Intervention Type
Drug
Intervention Name(s)
GnRH agonist trigger
Other Intervention Name(s)
Oovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.
Intervention Type
Drug
Intervention Name(s)
hCG trigger
Other Intervention Name(s)
Ovulation trigger with Ovitrelle 250 microgram., Luteal support with daily progesterone gel = Crinone 8%
Primary Outcome Measure Information:
Title
Fetal Heart Activity 1 Month After Oocyte Retrieval
Description
Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval
Time Frame
1 month after oocyte retrieval
Secondary Outcome Measure Information:
Title
Patients Comfort During the Luteal Phase
Time Frame
During 2 weeks from day of oocyte retrieval

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: IVF patients with at least 4 consecutive failures. On trigger day, no more than 10 follicles of 12 mm and up Exclusion Criteria: History of moderate or severe OHSS.
Facility Information:
Facility Name
IVF Unit, Rambam medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

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Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures

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