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

April 13, 2014 updated by: Nagihan CENGAVER, Zekai Tahir Burak Women's Health Research and Education Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06500
        • Zekai Tahir Burak Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LongGnRH agonist protocol(controlgroup)
Long GnRH agonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
Drug: vaginal progesterone
crinone gel is applied till fetal heart beat is detected
Other Names:
  • crinone gel
Drug: 4 mg oral estradiol valerate
estrofem is given twice a day
Other Names:
  • estrofem 2mg tablet
Experimental: Long protocol-leuprolide acetate
Long GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
Drug: vaginal progesterone
crinone gel is applied till fetal heart beat is detected
Other Names:
  • crinone gel
Drug: 4 mg oral estradiol valerate
estrofem is given twice a day
Other Names:
  • estrofem 2mg tablet
Drug: Leuprolide acetate
in experimentals groups,on fifth and tenth day after embryo transfer 0,5mg leuprolide acetate is given subcutaneously as luteal phase support
Other Names:
  • lucrin
Active Comparator: GnRHantagonist protocol(control group)
GnRH antagonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
Drug: vaginal progesterone
crinone gel is applied till fetal heart beat is detected
Other Names:
  • crinone gel
Drug: 4 mg oral estradiol valerate
estrofem is given twice a day
Other Names:
  • estrofem 2mg tablet
Experimental: antagonist protocol-leuprolide acetate
GnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
Drug: vaginal progesterone
crinone gel is applied till fetal heart beat is detected
Other Names:
  • crinone gel
Drug: 4 mg oral estradiol valerate
estrofem is given twice a day
Other Names:
  • estrofem 2mg tablet
Drug: Leuprolide acetate
in experimentals groups,on fifth and tenth day after embryo transfer 0,5mg leuprolide acetate is given subcutaneously as luteal phase support
Other Names:
  • lucrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live Birth Rate
Time Frame: 42 weeks
42 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy
Time Frame: more than 20 weeks
more than 20 weeks
miscarriage
Time Frame: up to 20 weeks
up to 20 weeks
OHSS
Time Frame: up to 10 weeks
up to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Investigators

  • Principal Investigator: Nagihan Cengaver, Resident, Zekai Tahir Burak Women's Health Research and Education Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 13, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

April 15, 2014

Last Update Submitted That Met QC Criteria

April 13, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZTB-5030
  • ZTB5030 (Registry Identifier: ZekaiTahirBurak)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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