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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status: Unknown

Conditions: Infertility

Treatments: Drug: 4 mg oral estradiol valerate; Drug: vaginal progesterone; Drug: Leuprolide acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT02114645

ZTB5030 (Registry Identifier)

ZTB-5030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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100 participants in 4 patient groups

LongGnRH agonist protocol(controlgroup)

Active Comparator group

Description:

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

Treatment:

Drug: 4 mg oral estradiol valerate

Drug: vaginal progesterone

Long protocol-leuprolide acetate

Experimental group

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

Treatment:

Drug: Leuprolide acetate

Drug: 4 mg oral estradiol valerate

Drug: vaginal progesterone

GnRHantagonist protocol(control group)

Active Comparator group

Description:

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

Treatment:

Drug: 4 mg oral estradiol valerate

Drug: vaginal progesterone

antagonist protocol-leuprolide acetate

Experimental group

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

Treatment:

Drug: Leuprolide acetate

Drug: 4 mg oral estradiol valerate

Drug: vaginal progesterone