NCT03930706

SHorter Treatment of Replacement Therapy for Frozen Embryo Transfer (FET)

Clinical Pregnancy Rate for Frozen Embryo Transfer With Hormonal Replacement Therapy (HRT): a Pilot Study Comparing 1 Versus 2 Weeks of Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
OTHER	Longer administration of estradiol (Progynova®)	All women included will take exogenous hormone with daily administration of Estradiol Valerate (Progynova®), the standard dose used will be 6 mg/day (Cobo et al., n.d.). On day 7 of endometrial preparation patients will be examined with vaginal ultrasound and blood test, to evaluate the endometrial thickness and the hormones levels. In both arms the FET will take place after 6 days of Progesterone supplementation (600 mg per day, vaginal administration of Utrogestan®) According to embryo quality after warming, embryo transfer to the uterine cavity will be performed on day 5 of development under ultrasound guidance whenever possible. Following embryo transfer, luteal support will be continued with vaginally administered P (Utrogestan®). All patients 12 days after the FET will undergo the pregnancy test (blood test to evaluate hCG).

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2019-04-29
• Last updated: 2021-09-29

Locations

1 site across 1 country: Belgium