Clinical trial NCT03518528: Comparison of Vaginal and Transdermal Oestrogen Before Frozen Thawed Embryo Transfer
Official title: Endometrial Estrogen Preparation Before Frozen-thawed Embryo Transfer : Comparison of Vaginal and Transdermal Administration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Embryo Transfer
Infertility
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-05-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients follow in our assisted reprodution unit, requesting frozen-thawed embryo transfer after ivf or icsi

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical pregnancy
timeFrame: 12 weeks
Secondary outcomes:
measure: chemical pregnancy
timeFrame: 6 weeks
measure: spontaneous pregnancy loss
timeFrame: 12 weeks
measure: plasmatic estradiol concentration on the day of transfer
timeFrame: 21 days
measure: plasmatic lh concentration on the day of transfer
timeFrame: 21 days
measure: plasmatic progesterone concentration on the day of transfer
timeFrame: 21 days
measure: endometrial thickness
timeFrame: 21 days
measure: annulation
timeFrame: 21 days
measure: treatment duration
timeFrame: 21 days
measure: satisfaction evaluated by anonymous survey the day of transfer
timeFrame: 1 month
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital, Angers
name: BOUET Pierre Emmanuel
role: STUDY_DIRECTOR
References: