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
1 other identifier
observational
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2018
CompletedFirst Posted
Study publicly available on registry
May 8, 2018
CompletedStudy Start
First participant enrolled
August 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 31, 2018
May 1, 2018
2 days
March 24, 2018
August 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
clinical pregnancy
defined as fetal cardiac activity at 12 weeks of gestation
12 weeks
Secondary Outcomes (9)
chemical pregnancy
6 weeks
spontaneous pregnancy loss
12 weeks
plasmatic estradiol concentration on the day of transfer
21 days
plasmatic lh concentration on the day of transfer
21 days
plasmatic progesterone concentration on the day of transfer
21 days
- +4 more secondary outcomes
Study Arms (2)
transdermal
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.
vaginal
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
Interventions
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
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.
Eligibility Criteria
patients follow in our assisted reprodution unit, requesting frozen-thawed embryo transfer after ivf or icsi
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Angers
Angers, 49100, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
BOUET Pierre Emmanuel
University Hospital, Angers
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2018
First Posted
May 8, 2018
Study Start
August 30, 2018
Primary Completion
September 1, 2018
Study Completion
December 1, 2018
Last Updated
August 31, 2018
Record last verified: 2018-05