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

NCT ID: NCT02114645

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LongGnRH agonist protocol(controlgroup)

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

Group Type ACTIVE_COMPARATOR

vaginal progesterone

Intervention Type DRUG

crinone gel is applied till fetal heart beat is detected

4 mg oral estradiol valerate

Intervention Type DRUG

estrofem is given twice a day

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

Group Type EXPERIMENTAL

Leuprolide acetate

Intervention Type DRUG

in experimentals groups,on fifth and tenth day after embryo transfer 0,5mg leuprolide acetate is given subcutaneously as luteal phase support

vaginal progesterone

Intervention Type DRUG

crinone gel is applied till fetal heart beat is detected

4 mg oral estradiol valerate

Intervention Type DRUG

estrofem is given twice a day

GnRHantagonist protocol(control group)

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

Group Type ACTIVE_COMPARATOR

vaginal progesterone

Intervention Type DRUG

crinone gel is applied till fetal heart beat is detected

4 mg oral estradiol valerate

Intervention Type DRUG

estrofem is given twice a day

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

Group Type EXPERIMENTAL

Leuprolide acetate

Intervention Type DRUG

in experimentals groups,on fifth and tenth day after embryo transfer 0,5mg leuprolide acetate is given subcutaneously as luteal phase support

vaginal progesterone

Intervention Type DRUG

crinone gel is applied till fetal heart beat is detected

4 mg oral estradiol valerate

Intervention Type DRUG

estrofem is given twice a day

Interventions

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Leuprolide acetate

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

vaginal progesterone

crinone gel is applied till fetal heart beat is detected

Intervention Type DRUG

4 mg oral estradiol valerate

estrofem is given twice a day

Intervention Type DRUG

Other Intervention Names

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lucrin crinone gel estrofem 2mg tablet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nagihan CENGAVER

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nagihan Cengaver, Resident

Role: PRINCIPAL_INVESTIGATOR

Zekai Tahir Burak Women's Health Research and Education Hospital

Locations

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Zekai Tahir Burak Hospital

Ankara, Cankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Nagihan Cengaver, MD

Role: CONTACT

+905556309298

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/?term=16926261

Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles.

Other Identifiers

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ZTB5030

Identifier Type: REGISTRY

Identifier Source: secondary_id

ZTB-5030

Identifier Type: -

Identifier Source: org_study_id

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