Frozen Embryo TransferPhase 4REMODELNCT04758871
Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles
A Phase 4 study testing Dydrogesterone 10 MG Oral Tablet and Micronized progesterone in people with Frozen Embryo Transfer and Hormone Replacement Therapy, run by CRG UZ Brussel at 1 site in Belgium.
Trial summary
To investigate the efficacy of dydrogesterone 30 mg compared to micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles, as confirmed by visualization of fetal heart activity by pelvic ultrasound assessment of ongoing pregnancy at 12 weeks of… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Frozen Embryo Transfer, Hormone Replacement Therapy, Dydrogesterone
- What is being tested?
- Dydrogesterone 10 MG Oral Tablet and Micronized progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2021to 13 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ≤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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dydrogesterone Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in Hormone Replacement Therapy (HRT) Frozen Embryo Transfer (FET) Cycles.
To investigate the efficacy of dydrogesterone 30 mg compared to micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles, as confirmed by visualization of fetal heart activity by pelvic ultrasound assessment of ongoing pregnancy at 12 weeks of gestation.
Read the detailed description
A randomized controlled trial comparing dydrogesterone 30 mg versus micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles. Patients will undergo an embryo transfer in a hormone replacement therapy cycle using Progynova 2 mg three times daily until an endometrium thickness of at least 7 mm is reached. Afterwards two different luteal phase supplementation methods will be compared. The primary outcome of the study is ongoing pregnancy at 12 weeks of gestation. We will also investigate other prenatal and neonatal outcome factors as well as patients satisfaction and safety of dydrogesterone.
- Being tested
- Dydrogesterone 10 MG Oral Tablet, Micronized progesterone
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dydrogesterone 10 MG Oral TabletDrug
10 mg three times daily
Micronized progesteroneDrug
2x 200 mg vaginal tablets two times daily
| Study group | Role | What they receive |
|---|---|---|
| Dydrogesterone | Experimental | Luteal phase support for hormone replacement therapy frozen embryo transfer cycles using dydrogesterone 10 mg 3 times daily Receives: Drug: Dydrogesterone 10 MG Oral Tablet |
| Micronized progesterone | Active comparator | Luteal phase support for hormone replacement therapy frozen embryo transfer cycles using micronized progesterone 2x200 mg twice daily vaginally Receives: Drug: Micronized progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy
visualisation of a fetal heart activity via pelvic (vaginal/abdominal) ultrasound examination at 12 weeks of gestation.
Measured: 12 weeks
Secondary outcomes (15)
Live birth rate
as the birth of a live newborn after 22 weeks of gestation
Measured: 22-42 weeks
Time of delivery
time of delivery (gestational week) will be confirmed (by calculation from date of embryo transfer)
Measured: follow-up time of 30 days after delivery
Incidence of Treatment-Emergent Adverse Events
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.
Measured: follow-up time of 30 days after delivery
Patient reported outcome
Questionnaire (using the Treatment Satisfaction Questionnaire of Medication (TSQM)) and recording information on treatment tolerability and convenience
Measured: day 12-18 of luteal phase supplementation (pregnancy test) and at 12 weeks gestation
Incidence of newborn adverse events
Newborn wellbeing and safety including congenital malformations will be evaluated after delivery via a telephonic contact with the patient
Measured: follow-up time of 30 days after delivery
Biochemical pregnancy rate
serum hCG test (> 25 mIU/ml), without ultrasound evaluation of a pregnancy
Measured: day 12-18 of luteal phase supplementation (pregnancy test)
Clinical pregnancy rate
assessed by transvaginal ultrasound and defined as the presence of ≥1 gestational sac on examination
Measured: Day 33-39 of LPS (Verification of pregnancy)
Miscarriage rate
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)
Measured: 22 weeks
Rate of preterm birth
Delivery before 37 weeks of gestation
Measured: follow-up time of 30 days after delivery
Rate of pre-eclampsia
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.
Measured: follow-up time of 30 days after delivery
Occurence of antenatal bleeding, ultrasonographic abnormalities, gestational diabetes, cholestasis
Occurence of antenatal bleeding, ultrasonographic abnormalities, gestational diabetes, cholestasis
Measured: follow-up time of 30 days after delivery
Implantation rate
assessed by ultrasound and defined as the number of gestational sacs per number of embryos transferred
Measured: Day 33-39 of LPS (Verification of pregnancy)
Blastocyst development score
using the system developed by Gardner
Measured: at the time of embryo transfer (visit 2: day 6 of luteal phase supplementation)
Number of cryopreserved embryos
Number of cryopreserved embryos
Measured: day of screening and enrollment
Summary characteristics of the preceding controlled ovarian stimulation cycle
information on used stimulation medication, total dose of stimulation medication used, duration of stimulation medication, trigger medication
Measured: day of screening and enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Oct 2021
- Primary completion11 Sep 2023
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen Embryo TransferStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- CRG UZ Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Roelens, CRG UZ Brussel
- Investigators
- Christophe Blockeel, Principal investigator, CRG UZ Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758871
- Sponsor's protocol ID
- REMODEL
- Acronym
- REMODEL
- Status last verified
- Jun 2024
- First submitted
- 26 Jan 2021
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dydrogesterone Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in Hormone Replacement Therapy (HRT) Frozen Embryo Transfer (FET) Cycles.
- ClinicalTrials.gov ID
- NCT04758871
- Acronym / sponsor ID
- REMODEL / REMODEL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- CRG UZ BrusselUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy of dydrogesterone 30 mg compared to micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles, as confirmed by visualization of fetal heart activity by pelvic ultrasound assessment of ongoing pregnancy at 12 weeks of gestation.
Detailed description
A randomized controlled trial comparing dydrogesterone 30 mg versus micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles. Patients will undergo an embryo transfer in a hormone replacement therapy cycle using Progynova 2 mg three times daily until an endometrium thickness of at least 7 mm is reached. Afterwards two different luteal phase supplementation methods will be compared. The primary outcome of the study is ongoing pregnancy at 12 weeks of gestation. We will also investigate other prenatal and neonatal outcome factors as well as patients satisfaction and safety of dydrogesterone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dydrogesterone | Experimental | Drug: Dydrogesterone 10 MG Oral TabletLuteal phase support for hormone replacement therapy frozen embryo transfer cycles using dydrogesterone 10 mg 3 times daily |
| Micronized progesterone | Active comparator | Drug: Micronized progesteroneLuteal phase support for hormone replacement therapy frozen embryo transfer cycles using micronized progesterone 2x200 mg twice daily vaginally |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- ≤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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dydrogesterone 10 MG Oral Tablet10 mg three times daily | Drug | Dydrogesterone |
| Micronized progesterone2x 200 mg vaginal tablets two times daily | Drug | Micronized progesterone |
Primary outcome
Ongoing pregnancy
Time frame: 12 weeks
visualisation of a fetal heart activity via pelvic (vaginal/abdominal) ultrasound examination at 12 weeks of gestation.
15 secondary outcomes
Live birth rate
Time frame: 22-42 weeks
Time of delivery
Time frame: follow-up time of 30 days after delivery
Incidence of Treatment-Emergent Adverse Events
Time frame: 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
Incidence of newborn adverse events
Time frame: follow-up time of 30 days after delivery
Biochemical pregnancy rate
Time frame: day 12-18 of luteal phase supplementation (pregnancy test)
Clinical pregnancy rate
Time frame: Day 33-39 of LPS (Verification of pregnancy)
Miscarriage rate
Time frame: 22 weeks
Rate of preterm birth
Time frame: follow-up time of 30 days after delivery
Rate of pre-eclampsia
Time frame: follow-up time of 30 days after delivery
Occurence of antenatal bleeding, ultrasonographic abnormalities, gestational diabetes, cholestasis
Time frame: follow-up time of 30 days after delivery
Implantation rate
Time frame: Day 33-39 of LPS (Verification of pregnancy)
Blastocyst development score
Time frame: at the time of embryo transfer (visit 2: day 6 of luteal phase supplementation)
Number of cryopreserved embryos
Time frame: day of screening and enrollment
Summary characteristics of the preceding controlled ovarian stimulation cycle
Time frame: day of screening and enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Blockeel principal investigator
CRG UZ Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dydrogesterone 10 MG Oral Tablet and Micronized progesterone in people with Frozen Embryo Transfer and Hormone Replacement Therapy, run by CRG UZ Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.