- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03930706
SHorter Treatment of Replacement Therapy for Frozen Embryo Transfer (FET) (ShoRT)
September 28, 2021 updated by: Blockeel Christophe, Universitair Ziekenhuis Brussel
Clinical Pregnancy Rate for Frozen Embryo Transfer With Hormonal Replacement Therapy (HRT): a Pilot Study Comparing 1 Versus 2 Weeks of Treatment
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussel, Belgium, 1090
- Universitair Ziekenhuis Brussel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
Group A will include all the patient that will start with progesterone ((P), Utrogestan®) supplementation after 7 days of E2 (Progynova®) intake and that will perform the FET (after 13 days of E2 and 6 days of P).
|
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:
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Active Comparator: Group B
Group B will include the patients that will perform 14 days of E2 intake (Progynova®, 6 mg per day (2 mg every 8 hours) those patients will be asked to perform a supplementary blood test and ultrasound on day 14 of E2 intake, afterwards, they will start with P supplementation (Utrogestan®, 800 mg per day, 400 mg every 12 hours) from day 15 of E2 for 6 days and they will get their FET day 20 of the cycle (after 14 days of E2 and 6 days of P)
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Pregnancy Rate
Time Frame: 2 years
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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.
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2 years
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Live Birth Rate
Time Frame: 4 years
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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.
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4 years
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Miscarriage rate
Time Frame: 2 years
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The spontaneous loss of an intra-uterine pregnancy prior to 22 completed weeks of gestational age, over the number of transferred embryos.
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
positive hCG tests
Time Frame: 2 years
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the number of participants with positive hCG measured on a blood sample 12 days after ET
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2 years
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biochemical pregnancy
Time Frame: 2 years
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the number of patients with positive hCG but no embryo development assessed
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2 years
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early pregnancy loss
Time Frame: 2 years
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the number of participants who had a pregnancy loss before 8 weeks of pregnancy
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Blockeel, Universitair Ziekenhuis Brussel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
March 31, 2021
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
April 16, 2019
First Submitted That Met QC Criteria
April 26, 2019
First Posted (Actual)
April 29, 2019
Study Record Updates
Last Update Posted (Actual)
September 29, 2021
Last Update Submitted That Met QC Criteria
September 28, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infertility
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Estradiol
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
Other Study ID Numbers
- HRT1vs2week.2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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