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

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

Study Overview

• Status: Unknown
• Conditions: Infertility; Embryo Transfer
• Intervention / Treatment: Drug: Estradiol 100 µg; Drug: Estradiol 2 MG

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • CHU Angers
    • Contact: CORROENNE ROMAIN; Phone Number: 33 0650678034; Email: corroenne.ROMAIN@gmail.com
    • Contact: BOUET PIERRE EMMANUEL; Phone Number: 0241353647; Email: PierreEmmanuel.BOUET@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

patients follow in our assisted reprodution unit, requesting frozen-thawed embryo transfer after ivf or icsi

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: vivelledot 100 µg
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	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; Other Names: provames 2mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy	defined as fetal cardiac activity at 12 weeks of gestation	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chemical pregnancy	Defined as serum HCG levels >10 IU/L, 14 days after the embryo transfer, followed by a rapid decrease until being undetectable	6 weeks
spontaneous pregnancy loss	Including early and late pregnancy losses	12 weeks
plasmatic estradiol concentration on the day of transfer	plasmatic estradiol concentration on the day of transfer	21 days
plasmatic lh concentration on the day of transfer	plasmatic lh concentration on the day of transfer	21 days
plasmatic progesterone concentration on the day of transfer	plasmatic progesterone concentration on the day of transfer	21 days
endometrial thickness	sonographic measurement of endometrial thickness on the day of transfer	21 days
annulation	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.	21 days
treatment duration	duration of treatment before transfer	21 days
satisfaction evaluated by anonymous survey the day of transfer	evaluated by anonymous survey the day of transfer	1 month

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Study Director: BOUET Pierre Emmanuel, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 24, 2018
• First Submitted That Met QC Criteria: May 6, 2018
• First Posted (Actual): May 8, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate
• Other Study ID Numbers: PATCHS2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No