NCT02114645

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

10 months

First QC Date

April 8, 2014

Last Update Submit

April 13, 2014

Conditions

Infertility

Keywords

Luteal phase support,GnRH agonist,ART cycles

Outcome Measures

Primary Outcomes (1)

  • Live Birth Rate

    42 weeks

Secondary Outcomes (3)

  • Ongoing pregnancy

    more than 20 weeks

  • miscarriage

    up to 20 weeks

  • OHSS

    up to 10 weeks

Study Arms (4)

LongGnRH agonist protocol(controlgroup)

ACTIVE COMPARATOR

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

Drug: vaginal progesteroneDrug: 4 mg oral estradiol valerate

Long protocol-leuprolide acetate

EXPERIMENTAL

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: Leuprolide acetateDrug: vaginal progesteroneDrug: 4 mg oral estradiol valerate

GnRHantagonist protocol(control group)

ACTIVE COMPARATOR

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

Drug: vaginal progesteroneDrug: 4 mg oral estradiol valerate

antagonist protocol-leuprolide acetate

EXPERIMENTAL

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: Leuprolide acetateDrug: vaginal progesteroneDrug: 4 mg oral estradiol valerate

Interventions

Leuprolide acetateDRUG

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

Also known as: lucrin
Long protocol-leuprolide acetateantagonist protocol-leuprolide acetate
vaginal progesteroneDRUG

crinone gel is applied till fetal heart beat is detected

Also known as: crinone gel
GnRHantagonist protocol(control group)Long protocol-leuprolide acetateLongGnRH agonist protocol(controlgroup)antagonist protocol-leuprolide acetate
4 mg oral estradiol valerateDRUG

estrofem is given twice a day

Also known as: estrofem 2mg tablet
GnRHantagonist protocol(control group)Long protocol-leuprolide acetateLongGnRH agonist protocol(controlgroup)antagonist protocol-leuprolide acetate

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients older than 38 years old
  • High and poor responder patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekai Tahir Burak Hospital

Ankara, Cankaya, 06500, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Infertility

Interventions

LeuprolideEstradiolestradiol, estriol drug combinationTablets

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesDosage FormsPharmaceutical Preparations

Study Officials

  • Nagihan Cengaver, Resident

    Zekai Tahir Burak Women's Health Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nagihan Cengaver, MD

CONTACT

+905556309298nagihancengaver@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

April 8, 2014

First Posted

April 15, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations

TU(1)