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

Not Applicable
Conditions
Infertility
Interventions
Drug: 4 mg oral estradiol valerate
Registration Number
NCT02114645
Lead Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
100
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
LongGnRH agonist protocol(controlgroup)vaginal progesteroneLong GnRH agonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
Long protocol-leuprolide acetateLeuprolide acetateLong GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
Long protocol-leuprolide acetatevaginal progesteroneLong GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
GnRHantagonist protocol(control group)vaginal progesteroneGnRH antagonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
antagonist protocol-leuprolide acetatevaginal progesteroneGnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
antagonist protocol-leuprolide acetateLeuprolide acetateGnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
LongGnRH agonist protocol(controlgroup)4 mg oral estradiol valerateLong GnRH agonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
Long protocol-leuprolide acetate4 mg oral estradiol valerateLong GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
GnRHantagonist protocol(control group)4 mg oral estradiol valerateGnRH antagonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate
antagonist protocol-leuprolide acetate4 mg oral estradiol valerateGnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer
Primary Outcome Measures
NameTimeMethod
Live Birth Rate42 weeks
Secondary Outcome Measures
NameTimeMethod
Ongoing pregnancymore than 20 weeks
miscarriageup to 20 weeks
OHSSup to 10 weeks

Trial Locations

Locations (1)

Zekai Tahir Burak Hospital

🇹🇷

Ankara, Cankaya, Turkey

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