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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04758871
Other study ID # REMODEL
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 1, 2021
Est. completion date June 13, 2024

Study information

Verified date June 2024
Source CRG UZ Brussel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 gestation.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 13, 2024
Est. primary completion date September 11, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

Drug:
Dydrogesterone 10 MG Oral Tablet
10 mg three times daily
Micronized progesterone
2x 200 mg vaginal tablets two times daily

Locations

Country Name City State
Belgium Brussels IVF Brussels

Sponsors (1)

Lead Sponsor Collaborator
CRG UZ Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ongoing pregnancy visualisation of a fetal heart activity via pelvic (vaginal/abdominal) ultrasound examination at 12 weeks of gestation. 12 weeks
Secondary Live birth rate as the birth of a live newborn after 22 weeks of gestation 22-42 weeks
Secondary Time of delivery time of delivery (gestational week) will be confirmed (by calculation from date of embryo transfer) follow-up time of 30 days after delivery
Secondary 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.
follow-up time of 30 days after delivery
Secondary Patient reported outcome Questionnaire (using the Treatment Satisfaction Questionnaire of Medication (TSQM)) and recording information on treatment tolerability and convenience day 12-18 of luteal phase supplementation (pregnancy test) and at 12 weeks gestation
Secondary Incidence of newborn adverse events 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
Secondary Biochemical pregnancy rate serum hCG test (> 25 mIU/ml), without ultrasound evaluation of a pregnancy day 12-18 of luteal phase supplementation (pregnancy test)
Secondary Clinical pregnancy rate assessed by transvaginal ultrasound and defined as the presence of =1 gestational sac on examination Day 33-39 of LPS (Verification of pregnancy)
Secondary 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) 22 weeks
Secondary Rate of preterm birth Delivery before 37 weeks of gestation follow-up time of 30 days after delivery
Secondary 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. follow-up time of 30 days after delivery
Secondary Occurence of antenatal bleeding, ultrasonographic abnormalities, gestational diabetes, cholestasis Occurence of antenatal bleeding, ultrasonographic abnormalities, gestational diabetes, cholestasis follow-up time of 30 days after delivery
Secondary Implantation rate assessed by ultrasound and defined as the number of gestational sacs per number of embryos transferred Day 33-39 of LPS (Verification of pregnancy)
Secondary Blastocyst development score using the system developed by Gardner at the time of embryo transfer (visit 2: day 6 of luteal phase supplementation)
Secondary Number of cryopreserved embryos Number of cryopreserved embryos day of screening and enrollment
Secondary 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 day of screening and enrollment
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