Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles

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

TERMINATED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-12-31

Brief Summary

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GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the fixed GnRH antagonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol were included. In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.

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Detailed Description

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Conditions

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Infertility

Study Groups

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GnRH agonist

Group Type EXPERIMENTAL

triptorelin acetate

Intervention Type DRUG

single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer

Saline

Group Type PLACEBO_COMPARATOR

NaCl %0.9

Intervention Type DRUG

0.1 ml sterile saline sc injection 3 days after embryo transfer

Interventions

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triptorelin acetate

single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer

Intervention Type DRUG

NaCl %0.9

0.1 ml sterile saline sc injection 3 days after embryo transfer

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol, oocyte pick-up and ICSI.
* Embryo transfer performed on day 3

Exclusion Criteria

* Participation in another trial that was being conducted in our unit at the same time.
* Preimplantation genetic screening cycles.
* Day 5 embryo transfers.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No