GnRH Agonist as Luteal Support in FET Cycles

NCT02620124 | Completed Phase 4

• 1 other identifier: T5/2013
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Infertility

Outcome Measures

Primary Outcomes (3)

• Pregnancy rate

  five weeks after the embryo transfer

• Implantation rate

  five weeks after the embryo transfer

• Ongoing pregnancy rate

  ten weeks after the embryo transfer

Secondary Outcomes (1)

• hCG- level

  14 days after thawing of the embryos

Study Arms (4)

Natural cycle, control

NO INTERVENTION

Treatment cycles with normal luteal support with progesteron

Natural cycle, intervention

EXPERIMENTAL

Treatment cycles with normal luteal support with progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days: Intervention is the additional 0.1 mg triptorelin as described in the previous sentence.

Drug: Natural cycle: Triptorelin acetate 0.1 mg

Hormone replacement cycle, control

NO INTERVENTION

Standard hormone replacement cycle with estrogen and progesteron

Hormone replacement cycle, intervention

EXPERIMENTAL

Standard hormone replacement cycle with estrogen and progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days

Drug: Natural cycle: Triptorelin acetate 0.1 mg; Drug: Hormone replacement cycle and triptorelin acetate 0.1 mg

Interventions

Natural cycle: Triptorelin acetate 0.1 mg DRUG

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, intervention; Natural cycle, intervention

Hormone replacement cycle and triptorelin acetate 0.1 mg DRUG

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

Hormone replacement cycle, intervention

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• year old women comig to frozen thawed embryo transfer

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Varpu Jokimaa, MD, PhD

  Hospital District of the South-West Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 2, 2015
• Study Start: May 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 23, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share