GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles

V.K.V. American Hospital, Istanbul

Status: Completed

Conditions: Infertility

Treatments: Drug: triptorelin acetate; Drug: Na Cl %0.9

Study type: Interventional

Funder types: Other

Identifiers

NCT00516490

AH-47/07

Details and patient eligibility

About

A single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles was reported to increase pregnancy and birth rates. This study was done to evaluate the reproducibility of previous findings.

Full description

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 long GnRH agonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist 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.

Enrollment: 570 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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570 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

GnRH agonist administration

Treatment:

Drug: triptorelin acetate

2

Placebo Comparator group

Description:

Sterile saline injection

Treatment:

Drug: Na Cl %0.9