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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02114645
• Other study ID #: ZTB-5030
• Secondary ID: ZTB5030
• Status: Not yet recruiting
• Phase: N/A
• First received: April 8, 2014
• Last updated: April 13, 2014
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2014
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: Nagihan Cengaver, MD
• Phone: +905556309298
• Email: nagihancengaver[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Leuprolide acetate
in experimentals groups,on fifth and tenth day after embryo transfer 0,5mg leuprolide acetate is given subcutaneously as luteal phase support
• vaginal progesterone
crinone gel is applied till fetal heart beat is detected
• 4 mg oral estradiol valerate
estrofem is given twice a day

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Hospital	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live Birth Rate		42 weeks	No
Secondary	Ongoing pregnancy		more than 20 weeks	No
Secondary	miscarriage		up to 20 weeks	No
Secondary	OHSS		up to 10 weeks	No

External Links

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