NCT03518528

Comparison of Vaginal and Transdermal Oestrogen Before Frozen Thawed Embryo Transfer

Endometrial Estrogen Preparation Before Frozen-thawed Embryo Transfer : Comparison of Vaginal and Transdermal Administration

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare pregnancy outcomes of frozen-thawed embryo transfer after endometrial preparation with vaginal estradiol or transdermal estradiol and to evaluate women's satisfaction

Detailed description

Frozen-thawed transfer embryo are more and more frequent but to date, there is no consensus on the ideal management of the adequate endometrial preparation. Artificial preparation of endometrium is commonly used in assisted reproduction center because it is more easy to schedule. Estradiol could be administrate by oral, vaginal or transdermal, but no protocol seems to improve clinical pregnancy rates. To investigator's knowledge, transdermal estradiol has never been compare to vaginal administration before frozen-thawed embryo transfer. Because transdermal administration could improve satisfaction of patients and reduce duration of treatment (when compare to oral administration), the investigators conduct a prospective study to compare clinical pregnancy rate after transdermal or vaginal estradiol administration to prepare the endometrium before frozen-thawed embryo transfer. The investigator also evaluate side effects and patients satisfaction in both protocol. The patients choose if they prefer vaginal or transdermal protocol after receiving sufficient information during medical consultation.

Conditions

• Embryo Transfer
• Infertility

Interventions

Type	Name	Description
DRUG	Estradiol 2 MG	Vaginal estradiol (Provames, Sanofi) 4mg per day from day 3 to first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks
DRUG	Estradiol 100 µg	transdermal estradiol (Vivelledot, Novartis) 100 µg on day 3, then 200 µg day 7 and every 4 days, until first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks.

Timeline

• Start date: 2018-08-30
• Primary completion: 2018-09-01
• Completion: 2018-12-01
• First posted: 2018-05-08
• Last updated: 2018-08-31

Locations

1 site across 1 country: France