GnRH Agonist as Luteal Support in FET Cycles

Infertility Clinical Trial

Official title:

GnRH Anonist as Luteal Support in Frozen-thawed Embryo Transfer Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620124
• Other study ID #: T5/2013
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2015
• Last updated: November 22, 2016
• Start date: May 2013
• Est. completion date: October 2015

Study information

• Verified date: November 2016
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish National Agency for Medicines
• Study type: Interventional

Clinical Trial Summary

Back ground: A single dose of GnRH analogue in the luteal phase is reported to improve the outcome of IVF/ICSI treatments but the effect in FET cycles has not been reported.

Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa analogue support Primary end point: IR, PR, on going PR Secondary end point: hCH, E2 and progesterone levels 14 days after thawing

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• 20 - 45 year old women comig to frozen thawed embryo transfer

Exclusion Criteria:

• The age of the woman over 42 years during the initial ICF/ICSI- treatment from which the embryos derive

• Abnormal uterus

• Known abnormality of karyotype of the woman or her partner

• Severe male factor as an exclusive reason for subfertility

• Allegy for triptorelin acetate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Natural cycle: Triptorelin acetate 0.1 mg
A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in additon to standard micronized progesterone 400 mg vaginally
• Hormone replacement cycle and triptorelin acetate 0.1 mg
A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in addition to standard Estradiol and progesterone support

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate		five weeks after the embryo transfer	No
Primary	Implantation rate		five weeks after the embryo transfer	No
Primary	Ongoing pregnancy rate		ten weeks after the embryo transfer	No
Secondary	hCG- level		14 days after thawing of the embryos	No