Endometrial Priming for Embryo Transfer

Sterility Clinical Trial

Official title:

A Randomised Control Trial to Evaluate Efficacy and Safety of Two Different Protocols of Endometrial Priming for Embryo Transfer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430650
• Other study ID #: UREP-PREPENDO-2010
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2011
• Last updated: September 19, 2017
• Start date: July 2010
• Est. completion date: July 2015

Study information

• Verified date: September 2017
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

• women that receive oral estrogens

• women that receive transdermal estrogens

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Sterility

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between day means in endometrial priming to achieve 7 mm.		11-16 days
Secondary	Biochemical Pregnancy rate	To calculate the biochemical pregnancy rate, we will divide the number of biochemical pregnancy into the number of embryonary transference and multiply by 100.	26-30 days
Secondary	The patient's adherence to the recommended treatment.		1-16 days