Clinical trial NCT03930706: SHorter Treatment of Replacement Therapy for Frozen Embryo Transfer (FET)
Official title: Clinical Pregnancy Rate for Frozen Embryo Transfer With Hormonal Replacement Therapy (HRT): a Pilot Study Comparing 1 Versus 2 Weeks of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Single-centre pilot study, randomized, controlled open-label trial with the aim to assess the clinical pregnancy rate and the early pregnancy loss rate between two different schemas for frozen embryo transfer cycles stimulated with HRT. Furthermore, the investigators would like to evaluate the predictivity of pregnancy and early miscarriage by looking at the endocrinological profile (estradiol and progesterone levels) within the endometrial preparation and the day of embryo transfer (ET).

Detailed description: Women planned for a FET-HRT will be asked to do a blood test day 1 of their cycle in order to evaluate the endocrine profile; those with basal hormonal values will receive 6 mg oral estradiol daily beginning from day 1 of their cycle. On day 7 of the treatment a blood test for the serum hormone evaluation and an ultrasound will be planned in order to evaluate the endometrium thickness; those who will meet the criteria (endometrium thickness ≥7mm) will be randomized. In the 7 days estradiol (E2) arm (A) the study coordinator will plan the FET after 6 days of progesterone supplementation (13 days of E2 intake). In the 14 days E2 arm (B) the team will plan on day 14 of treatment with E2 the serum hormone evaluation and an ultrasound in order to evaluate the endometrium thickness, consequently the FET will be planned after 6 days of progesterone supplementation (after 14 days of E2 intake). Furthermore, all the patients included in the study will undergo a blood test on the day of the transfer for the evaluation of the hormones level. For the assessment of the pregnancy a first blood test will take place 12 days after the ET and a blood test with an ultrasound will take place at 7 weeks for the evaluation of the clinical pregnancy.

Eligibility criteria: * Women aged ≥18 and \< 40 years
* Unexplained infertility
* Normal uterine cavity
* IVF/ICSI
* IVF cycle with GnRH agonist or antagonist
* Single day 5 blastocyst transfer
* Top quality embryo (at least Bl 3BA) at the moment of ET
* Signed informed consent
* Participants can be included only once in the trial
* Informed consent documents signed prior to screening evalua-tions.

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 2 years
measure: Live Birth Rate
timeFrame: 4 years
measure: Miscarriage rate
timeFrame: 2 years
Secondary outcomes:
measure: positive hCG tests
timeFrame: 2 years
measure: biochemical pregnancy
timeFrame: 2 years
measure: early pregnancy loss
timeFrame: 2 years
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Blockeel
role: PRINCIPAL_INVESTIGATOR
References: