Comparison of Vaginal and Transdermal Oestrogen Before Frozen Thawed Embryo Transfer

Infertility Clinical Trial

Official title:

Endometrial Estrogen Preparation Before Frozen-thawed Embryo Transfer : Comparison of Vaginal and Transdermal Administration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03518528
• Other study ID #: PATCHS2018
• Status: Recruiting
• Start date: August 30, 2018
• Est. completion date: December 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Angers
• Contact: BOUET Pierre-Emmanuel, MD
• Phone: +33241353637
• Email: pierreemmanuel.bouet[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Embryo Transfer
• Infertility

Intervention

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
• 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.

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy	defined as fetal cardiac activity at 12 weeks of gestation	12 weeks
Secondary	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
Secondary	spontaneous pregnancy loss	Including early and late pregnancy losses	12 weeks
Secondary	plasmatic estradiol concentration on the day of transfer	plasmatic estradiol concentration on the day of transfer	21 days
Secondary	plasmatic lh concentration on the day of transfer	plasmatic lh concentration on the day of transfer	21 days
Secondary	plasmatic progesterone concentration on the day of transfer	plasmatic progesterone concentration on the day of transfer	21 days
Secondary	endometrial thickness	sonographic measurement of endometrial thickness on the day of transfer	21 days
Secondary	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
Secondary	treatment duration	duration of treatment before transfer	21 days
Secondary	satisfaction evaluated by anonymous survey the day of transfer	evaluated by anonymous survey the day of transfer	1 month