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Comparison of Vaginal and Transdermal Oestrogen Before Frozen Thawed Embryo Transfer

U

University Hospital, Angers

Status

Unknown

Conditions

Infertility
Embryo Transfer

Treatments

Drug: Estradiol 2 MG
Drug: Estradiol 100 µg

Study type

Observational

Funder types

Other

Identifiers

NCT03518528
PATCHS2018

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 43 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

transdermal
Description:
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.
Treatment:
Drug: Estradiol 100 µg
vaginal
Description:
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
Treatment:
Drug: Estradiol 2 MG

Trial contacts and locations

1

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Central trial contact

BOUET Pierre-Emmanuel, MD; CORROENNE Romain

Data sourced from clinicaltrials.gov

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