Comparison of Vaginal and Transdermal Oestrogen Before Frozen Thawed Embryo Transfer

University Hospital, Angers

Status: Unknown

Conditions: Infertility; Embryo Transfer

Treatments: Drug: Estradiol 2 MG; Drug: Estradiol 100 µg

Study type: Observational

Funder types: Other

Identifiers

NCT03518528

PATCHS2018

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18 and <43
• frozen-thawed embryo transfer after exogenously administered estrogen in either way transdermal or vaginal
• patients who accepted being included and signed the consent forms.

Exclusion criteria

• patient who refuse to participate
• frozen-thawed embryotransfer after stimulated or natural cycle
• oocyte or sperm donation
• endometrial thickness after 21 days <6mm
• non-french speaking patients
• women under legal guardianship
• women with no health or social security coverage

Trial design

100 participants in 2 patient groups

transdermal

Description:

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.

Treatment:

Drug: Estradiol 100 µg

vaginal

Description:

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

Treatment:

Drug: Estradiol 2 MG