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Completed

NCT Number: NCT04758871

Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer 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.

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Key information

Conditions

Frozen Embryo Transfer Dydrogesterone Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hormone Replacement Therapy Infertility Infertility, Female Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brussels IVF

Brussels, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dydrogesterone 10 MG Oral Tablet

Drug

10 mg three times daily

Micronized progesterone

Drug

2x 200 mg vaginal tablets two times daily

Primary outcomes

  1. Ongoing pregnancy

    Time frame: 12 weeks

    visualisation of a fetal heart activity via pelvic (vaginal/abdominal) ultrasound examination at 12 weeks of gestation.

Secondary outcomes

  1. Live birth rate

    Time frame: 22-42 weeks

    as the birth of a live newborn after 22 weeks of gestation

  2. 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)

  3. 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.

  4. 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

  5. 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

  6. 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

  7. Clinical pregnancy rate

    Time frame: Day 33-39 of LPS (Verification of pregnancy)

    assessed by transvaginal ultrasound and defined as the presence of ≥1 gestational sac on examination

  8. 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)

  9. Rate of preterm birth

    Time frame: follow-up time of 30 days after delivery

    Delivery before 37 weeks of gestation

  10. Rate of pre-eclampsia

    Time frame: follow-up time of 30 days after delivery

    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.

  11. Occurence of antenatal bleeding, ultrasonographic abnormalities, gestational diabetes, cholestasis

    Time frame: follow-up time of 30 days after delivery

    Occurence of antenatal bleeding, ultrasonographic abnormalities, gestational diabetes, cholestasis

  12. Implantation rate

    Time frame: Day 33-39 of LPS (Verification of pregnancy)

    assessed by ultrasound and defined as the number of gestational sacs per number of embryos transferred

  13. Blastocyst development score

    Time frame: at the time of embryo transfer (visit 2: day 6 of luteal phase supplementation)

    using the system developed by Gardner

  14. Number of cryopreserved embryos

    Time frame: day of screening and enrollment

    Number of cryopreserved embryos

  15. 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

Sponsors and collaborators

Lead sponsor

CRG UZ Brussel

Other

Registry information

Official study title

Dydrogesterone Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in Hormone Replacement Therapy (HRT) Frozen Embryo Transfer (FET) Cycles.

Acronym: REMODEL

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 17, 2021
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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