Embryo Transfer, Infertility
Conditions
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.
Interventions
DRUGEstradiol 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
DRUGEstradiol 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.
Sponsors
University Hospital, Angers
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy | 12 weeks | defined as fetal cardiac activity at 12 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| spontaneous pregnancy loss | 12 weeks | Including early and late pregnancy losses |
| plasmatic estradiol concentration on the day of transfer | 21 days | plasmatic estradiol concentration on the day of transfer |
| plasmatic lh concentration on the day of transfer | 21 days | plasmatic lh concentration on the day of transfer |
| plasmatic progesterone concentration on the day of transfer | 21 days | plasmatic progesterone concentration on the day of transfer |
| chemical pregnancy | 6 weeks | Defined as serum HCG levels \>10 IU/L, 14 days after the embryo transfer, followed by a rapid decrease until being undetectable |
| annulation | 21 days | defined when transfer is cancel if endometrial thickness is too thick (\>6-7mm), when spontaneous ovulation is found with progesterone plasmatic increase and corpus luteum is seen by sonography or when unpredictable events occur (infections, ZIKA suspicion, endometriosis crisis, bad observance…). Annulation could be decided by biologist in case of embryo's lysis or bad quality seen after thawing. |
| treatment duration | 21 days | duration of treatment before transfer |
| satisfaction evaluated by anonymous survey the day of transfer | 1 month | evaluated by anonymous survey the day of transfer |
| endometrial thickness | 21 days | sonographic measurement of endometrial thickness on the day of transfer |
Countries
France
Contacts
Primary ContactBOUET Pierre-Emmanuel, MD
Backup ContactCORROENNE Romain
Outcome results
None listed