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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930706
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Blockeel Christophe, Universitair Ziekenhuis Brussel

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).

Condition or disease Intervention/treatment Phase
Infertility Other: Longer administration of estradiol (Progynova®) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Pregnancy Rate for Frozen Embryo Transfer With Hormonal Replacement Therapy (HRT): a Pilot Study Comparing 1 Versus 2 Weeks of Treatment
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930706


Contacts
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Contact: Christophe Blockeel, Professor 024749784 annalisa.racca@uzbrussel.be

Locations
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Belgium
Universitair Ziekenhuis Brussel Recruiting
Brussel, Belgium, 1090
Contact: Christophe Blockeel, PhD    +3224776699    christophe.blockeel@uzbrussel.Be   
Contact: Sylvie De Rijdt, MD       sylvie.derijdt@uzbrussel.be   
Principal Investigator: Christophe Blockeel, PhD         
Principal Investigator: Annalisa Racca, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Blockeel Universitair Ziekenhuis Brussel
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Responsible Party: Blockeel Christophe, Professor Doctor, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03930706    
Other Study ID Numbers: HRT1vs2week.2018
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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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
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female