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Endometrial Priming for Embryo Transfer

This study is currently recruiting participants.
Verified February 2013 by Parc de Salut Mar
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01430650
First received: June 20, 2011
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

The aim of this trial is compare two different endometrial priming protocols

  • women that receive oral estrogens
  • women that receive transdermal estrogens

Condition Intervention Phase
Sterility
 Drug: Oral strogen
Drug: Transdermal strogen
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Control Trial to Evaluate Efficacy and Safety of Two Different Protocols of Endometrial Priming for Embryo Transfer.

Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Difference between day means in endometrial priming to achieve 7 mm. [ Time Frame: 11-16 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical Pregnancy rate [ Time Frame: 26-30 days ] [ Designated as safety issue: No ]
    To calculate the biochemical pregnancy rate, we will divide the number of biochemical pregnancy into the number of embryonary transference and multiply by 100.

  • The patient's adherence to the recommended treatment. [ Time Frame: 1-16 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 134
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral strogen Drug: Oral strogen
2 mg of estradiol every day beginning the second day of the cycle until day 7. 4 mg of estradiol every day beginning 8th day of the cycle until day 10. 6 mg of estradiol every day beginning 11th day of the cycle until day 16.
Experimental: Transdermal strogen Drug: Transdermal strogen
One patch of 75 mcg of estradiol hemimydrate every 48 h from 2 to day 6. Two patches of 75 mcg of estradiol hemimydrate every 48 h from 6 to day 12. Three patches of 75 mcg of estradiol hemimydrate every 48 h from 12 to day 16.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women between 18-50 years old with desire of children and needs of embryo transfer.
  • Plasma prolactin less than 30.
  • Uterine cavity that allow pregnancy, body mass index between 20-30.
  • And signed consent inform.

Exclusion Criteria:

  • History of estrogen dependent cancer, unknown origin vaginal bleeding.
  • Ovarian cyst.
  • Contraindications to be pregnant.
  • Estrogen allergy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430650

Contacts
Contact: Miguel Angel Checa, PhD 0034 93 248 31 29 macheca@parcdesalutmar.cat

Locations
Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Miguel Angel Checa, Phd     0034 93 248 31 29     macheca@parcdesalutmar.cat    
Principal Investigator: Miguel Angel Checa, PhD            
Sponsors and Collaborators
Parc de Salut Mar
  More Information

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01430650     History of Changes
Other Study ID Numbers: UREP-PREPENDO-2010
Study First Received: June 20, 2011
Last Updated: February 14, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Parc de Salut Mar:
Oral estrogens
transdermal estrogens
endometrial priming

Additional relevant MeSH terms:
Adenoma
Infertility
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Diseases, Male
Genital Diseases, Female
Permixon
 Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Androgen Antagonists

ClinicalTrials.gov processed this record on June 17, 2013