- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04758871
Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles (REMODEL)
Dydrogesterone Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in Hormone Replacement Therapy (HRT) Frozen Embryo Transfer (FET) Cycles.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Elsie Nulens
- Phone Number: 00322477668
- Email: studieverpleegkundigen_crg@uzbrussel.be
Study Locations
-
-
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Brussels, Belgium, 1090
- Brussels IVF
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≤40 years of age at the time of IVF/ICSI treatment
- BMI ≥18 to ≤30 kg/m2 with a documented history of infertility
- Have undergone COS as part of an ART treatment and have had an unsuccessful fresh embryo transfer in that cycle, OR, have undergone freeze all strategy
- Scheduled to undergo FET with a standard exogenous/programmed hormonal replacement therapy (HRT) regimen
- Have at least 1 blastocyst vitrified on the 5th or 6th day after oocyte retrieval
- Elective single embryo (blastocyst) transfer (SET)
- Normal ultrasound examination at enrollment (or if <12 months old)
- Signed patient authorization for use/disclosure of data.
Exclusion Criteria:
- Women with a history of recurrent miscarriage, defined as >2 consecutive miscarriages (biochemical pregnancy losses are not included)
- Absence of implantation (serum hCG = negative) after two consecutive cycles of IVF, ICSI or FET where the cumulative number of transferred embryos was >4 cleavage-stage embryos and >2 blastocysts
- Presence of hydrosalpinx that is not surgically treated
- Endometrial abnormalities on scanning during ovarian stimulation, such as endometrial polyp(s), sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid accumulation, or endometrial adhesions
- Participating in another clinical study at the same time
- Known allergic reactions to dydrogesterone or other progestogens products
- Any contraindication or other condition that precludes use of dydrogesterone in a particular patient, in accordance with the precautions listed in the locally approved label
- Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects in or to complete the study
- History of prior chemotherapy
- Contraindication for pregnancy
- Transfer of >1 embryo
Study Plan
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: Dydrogesterone
Luteal phase support for hormone replacement therapy frozen embryo transfer cycles using dydrogesterone 10 mg 3 times daily
|
10 mg three times daily
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Active Comparator: Micronized progesterone
Luteal phase support for hormone replacement therapy frozen embryo transfer cycles using micronized progesterone 2x200 mg twice daily vaginally
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2x 200 mg vaginal tablets two times daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ongoing pregnancy
Time Frame: 12 weeks
|
visualisation of a fetal heart activity via pelvic (vaginal/abdominal) ultrasound examination at 12 weeks of gestation.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Live birth rate
Time Frame: 22-42 weeks
|
as the birth of a live newborn after 22 weeks of gestation
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22-42 weeks
|
Time of delivery
Time Frame: follow-up time of 30 days after delivery
|
time of delivery (gestational week) will be confirmed (by calculation from date of embryo transfer)
|
follow-up time of 30 days after delivery
|
Incidence of Treatment-Emergent Adverse Events
Time Frame: follow-up time of 30 days after delivery
|
Tolerability and safety will be asses during the whole study period. Adverse events will be considered as unexpected if the nature, seriousness, severity or outcome of the reaction(s) is not consistent with the reference information. The expectedness of adverse events for the medications used in this study is detailed in the reference safety information in the current summary of product characteristics (SmPCs) issued in the participating countries. All serieus suspected unexpected serious adverse drug reactions (SUSARs) will be subject to expedited reporting. The investigator is responsible for submitting reports of SUSARs to the appropriate national regulatory authorities within the required reporting period. The investigator is responsible for notifying the IECs/IRBs in writing of the SUSARs within the required reporting timelines. Copies of the notification will be maintained by the investigator in the study documentation files. |
follow-up time of 30 days after delivery
|
Patient reported outcome
Time Frame: day 12-18 of luteal phase supplementation (pregnancy test) and at 12 weeks gestation
|
Questionnaire (using the Treatment Satisfaction Questionnaire of Medication (TSQM)) and recording information on treatment tolerability and convenience
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day 12-18 of luteal phase supplementation (pregnancy test) and at 12 weeks gestation
|
Incidence of newborn adverse events
Time Frame: follow-up time of 30 days after delivery
|
Newborn wellbeing and safety including congenital malformations will be evaluated after delivery via a telephonic contact with the patient
|
follow-up time of 30 days after delivery
|
Biochemical pregnancy rate
Time Frame: day 12-18 of luteal phase supplementation (pregnancy test)
|
serum hCG test (> 25 mIU/ml), without ultrasound evaluation of a pregnancy
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day 12-18 of luteal phase supplementation (pregnancy test)
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Clinical pregnancy rate
Time Frame: Day 33-39 of LPS (Verification of pregnancy)
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assessed by transvaginal ultrasound and defined as the presence of ≥1 gestational sac on examination
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Day 33-39 of LPS (Verification of pregnancy)
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Miscarriage rate
Time Frame: 22 weeks
|
defined as spontaneous loss of a clinical pregnancy before 22 weeks of gestation (where embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus)
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22 weeks
|
Rate of preterm birth
Time Frame: follow-up time of 30 days after delivery
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Delivery before 37 weeks of gestation
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follow-up time of 30 days after delivery
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Rate of pre-eclampsia
Time Frame: follow-up time of 30 days after delivery
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Incidence of pre-eclampsia as defined by the defined as the development of hypertension after 20 weeks of gestation together with one or more new-onset conditions: proteinuria, maternal or uteroplacental dysfunctions.
Univariate and multivariable regression analysis were performed to control for known or potential PE risk factors, more specifically: body mass index (BMI), African ethnicity, previous history of hypertensive disorders of pregnancy, mean arterial pressure (MAP) at the first prenatal consultation, polycystic ovary syndrome (PCOS) and ovulation disorders, endometrial thickness and oocyte recipients.
|
follow-up time of 30 days after delivery
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Occurence of antenatal bleeding, ultrasonographic abnormalities, gestational diabetes, cholestasis
Time Frame: follow-up time of 30 days after delivery
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Occurence of antenatal bleeding, ultrasonographic abnormalities, gestational diabetes, cholestasis
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follow-up time of 30 days after delivery
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Implantation rate
Time Frame: Day 33-39 of LPS (Verification of pregnancy)
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assessed by ultrasound and defined as the number of gestational sacs per number of embryos transferred
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Day 33-39 of LPS (Verification of pregnancy)
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Blastocyst development score
Time Frame: at the time of embryo transfer (visit 2: day 6 of luteal phase supplementation)
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using the system developed by Gardner
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at the time of embryo transfer (visit 2: day 6 of luteal phase supplementation)
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Number of cryopreserved embryos
Time Frame: day of screening and enrollment
|
Number of cryopreserved embryos
|
day of screening and enrollment
|
Summary characteristics of the preceding controlled ovarian stimulation cycle
Time Frame: day of screening and enrollment
|
information on used stimulation medication, total dose of stimulation medication used, duration of stimulation medication, trigger medication
|
day of screening and enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christophe Blockeel, CRG UZ Brussel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Infertility
- Infertility, Female
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Progestins
- Progesterone
- Dydrogesterone
Other Study ID Numbers
- REMODEL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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