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The Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Leuprolide acetate
vaginal progesterone
4 mg oral estradiol valerate
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Luteal phase support,GnRH agonist,ART cycles

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Couples undergoing ART with their own gametes.
  • Couples having at least one good embryo available for transfer.
  • Normoresponder
  • Infertility etiology is unexplained
  • ovulation triggered by intramuscular injection of 10000 IU of HCG

Exclusion Criteria:

Patients older than 38 years old

  • High and poor responder patients

Sites / Locations

  • Zekai Tahir Burak Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

LongGnRH agonist protocol(controlgroup)

Long protocol-leuprolide acetate

GnRHantagonist protocol(control group)

antagonist protocol-leuprolide acetate

Arm Description

Long GnRH agonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate

Long GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer

GnRH antagonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate

GnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer

Outcomes

Primary Outcome Measures

Live Birth Rate

Secondary Outcome Measures

Ongoing pregnancy
miscarriage
OHSS

Full Information

First Posted
April 8, 2014
Last Updated
April 13, 2014
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02114645
Brief Title
The Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes
Official Title
To Evaluate the Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes in Both GnRH Agonist and GnRH Antagonist Treated Ovarian Stimulation Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol.
Detailed Description
This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol. Decision between each of these two protocols was subjective and depended on the clinical context.In addition to routine luteal phase support with progesterone and estradiol valerate,women received two dose of GnRH agonist on the fifth and tenth day after ET.Live birth rate was the primary outcome measure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Luteal phase support,GnRH agonist,ART cycles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LongGnRH agonist protocol(controlgroup)
Arm Type
Active Comparator
Arm Description
Long GnRH agonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
Arm Title
Long protocol-leuprolide acetate
Arm Type
Experimental
Arm Description
Long GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
Arm Title
GnRHantagonist protocol(control group)
Arm Type
Active Comparator
Arm Description
GnRH antagonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
Arm Title
antagonist protocol-leuprolide acetate
Arm Type
Experimental
Arm Description
GnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
Intervention Type
Drug
Intervention Name(s)
Leuprolide acetate
Other Intervention Name(s)
lucrin
Intervention Description
in experimentals groups,on fifth and tenth day after embryo transfer 0,5mg leuprolide acetate is given subcutaneously as luteal phase support
Intervention Type
Drug
Intervention Name(s)
vaginal progesterone
Other Intervention Name(s)
crinone gel
Intervention Description
crinone gel is applied till fetal heart beat is detected
Intervention Type
Drug
Intervention Name(s)
4 mg oral estradiol valerate
Other Intervention Name(s)
estrofem 2mg tablet
Intervention Description
estrofem is given twice a day
Primary Outcome Measure Information:
Title
Live Birth Rate
Time Frame
42 weeks
Secondary Outcome Measure Information:
Title
Ongoing pregnancy
Time Frame
more than 20 weeks
Title
miscarriage
Time Frame
up to 20 weeks
Title
OHSS
Time Frame
up to 10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Couples undergoing ART with their own gametes. Couples having at least one good embryo available for transfer. Normoresponder Infertility etiology is unexplained ovulation triggered by intramuscular injection of 10000 IU of HCG Exclusion Criteria: Patients older than 38 years old High and poor responder patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nagihan Cengaver, MD
Phone
+905556309298
Email
nagihancengaver@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagihan Cengaver, Resident
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zekai Tahir Burak Hospital
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06500
Country
Turkey

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=16926261
Description
Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles.

Learn more about this trial

The Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes

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