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Completed

NCT Number: NCT03930706

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

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).

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Longer administration of estradiol (Progynova®)

Other

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).

Other names: comparing 7 vs 14 days of administration of estradiol (Progynova®) for artificially prepared endometrium in frozen embryo transfer

Primary outcomes

  1. Clinical Pregnancy Rate

    Time frame: 2 years

    The number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles or embryo transfer cycles. When clinical pregnancy rates are recorded, the denominator (initiated, aspirated or embryo transfer cycles) must be specified.

  2. Live Birth Rate

    Time frame: 4 years

    The number of deliveries that resulted in at least one live birth, expressed per 100 cycle attempts. In the case of assisted reproductive technologies (ART) interventions, they can be initiated cycles, insemination, aspiration cycles or embryo transfer cycles. When delivery rates are given, the denominator (initiated, inseminated, aspirated or embryo transfer cycles) must be specified.

  3. Miscarriage rate

    Time frame: 2 years

    The spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age, over the number of transferred embryos.

Secondary outcomes

  1. positive hCG tests

    Time frame: 2 years

    the number of participants with positive hCG measured on a blood sample 12 days after ET

  2. biochemical pregnancy

    Time frame: 2 years

    the number of patients with positive hCG but no embryo development assessed

  3. early pregnancy loss

    Time frame: 2 years

    the number of participants who had a pregnancy loss before 8 weeks of pregnancy

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Acronym: ShoRT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2019
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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