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Clinical Trials/NCT02114645
NCT02114645
Unknown
Not Applicable

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

Zekai Tahir Burak Women's Health Research and Education Hospital1 site in 1 country100 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
vaginal progesterone
Conditions
Infertility
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Enrollment
100
Locations
1
Primary Endpoint
Live Birth Rate
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
April 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Responsible Party
Principal Investigator
Principal Investigator

Nagihan CENGAVER

Resident

Zekai Tahir Burak Women's Health Research and Education Hospital

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

Arms & Interventions

LongGnRH agonist protocol(controlgroup)

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

Intervention: vaginal progesterone

LongGnRH agonist protocol(controlgroup)

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

Intervention: 4 mg oral estradiol valerate

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

Intervention: Leuprolide acetate

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

Intervention: Leuprolide acetate

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

Intervention: vaginal progesterone

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

Intervention: 4 mg oral estradiol valerate

GnRHantagonist protocol(control group)

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

Intervention: vaginal progesterone

GnRHantagonist protocol(control group)

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

Intervention: 4 mg oral estradiol valerate

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

Intervention: vaginal progesterone

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

Intervention: 4 mg oral estradiol valerate

Outcomes

Primary Outcomes

Live Birth Rate

Time Frame: 42 weeks

Secondary Outcomes

  • Ongoing pregnancy(more than 20 weeks)
  • miscarriage(up to 20 weeks)
  • OHSS(up to 10 weeks)

Study Sites (1)

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