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Completed

NCT Number: NCT03998761

Progesterone Versus Progesterone Plus Dydrogesterone in FET

Frozen embryo transfer (FET) has been increasing important in IVF. Progesterone is essential for the endometrial secretory transformation, establishment and maintenance of pregnancy. In FET, as there is neither corpus luteum nor the support of hCG, the role of progesterone is even more important to ensure a sufficient luteal phase support.

Vaginal progesterone has been the most common preparation for luteal support in fresh embryo transfer during IVF because of their ease of use and comparable effectiveness compared to intramuscular progesterone. Recently, there was evidence of the considerable variation in uptake, absorption and metabolism of intra-vaginal micronized progesterone. Dydrogesterone alone has described to have similar effectiveness, safety and tolerability prolfiles for luteal phase support compared to vaginal progesterone in luteal phase support for fresh embryo transfer. This prospective study compares the effectiveness of micronized progesterone versus micronized progesterone plus dydrogesterone for luteal phase support in FET.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

About this study

All patients undergoing FET will receive oral estradiol valerate (Valiera®; Laboratories Recalcine) 8 mg/day from the second or third day of menses for 6 days. Endometrial thickness will be monitored from day six onwards. From day 8-9 of menses, the estradiol dose could be adjusted from 8mg/day to 16mg/day according the development of the endometrium. Progesterone will be started when endometrial thickness reached 8 mm or more. In the first four months, all the patients will be treated with micronized progesterone. In five months later, the intervention will be changed to micronized progesterone plus dydrogesterone. In the second group of patients, the duration of study will be extended for one month due to the Lunar New Year holiday.

Group 1: Micronized progesterone Patients will receive micronized progesterone (Cyclogest® 400mg; Actavis) at the dose of 400mg twice daily (morning and evening).

Group 2: Micronized progesterone plus dydrogesterone Patients will receive micronized progesterone (Cyclogest® 400mg; Actavis) at the dose of 400mg twice daily (morning and evening) plus dydrogesterone (Duphaston 10mg) at the dose of 10mg twice daily (morning and evening).

In both group, on the day of starting progesterone, the dose of estradiol will be decreased to 8mg/day. A maximum of 2 embryos will be thawed on the day of embryo transfer, which is four days or six days after the start of progesterone depending on day-3 or day-5 embryo transfer. After thawing, surviving embryos will be transferred into the uterus under ultrasound guidance. Estradiol and progesterone will be continued until the day of pregnancy test. If the pregnancy test is positive, the patients will continue to use 800 mg micronized progesterone or 800 mg micronized progesterone plus 20 mg dydrogestetrone, until 7 weeks of gestation.

Blood samples will be obtained at day 4 after the use of progesterone. Serum progesterone will be measured. The blood tests will be taken in the morning, 2-3 h after the dydrogesterone and/or micronized progesterone application.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing frozen embryo transfer
  • Endometrial prepared by exogenous hormonal regimen
  • Permanent resident in Vietnam

Exclusion criteria

  • Having > 2 embryo transfer attempts
  • Having embryo(s) from donors cycles
  • Having embryo(s) from IVM
  • Having embryo(s) from PGT/PGS
  • Having endometrial abnormalities: polyp, sub-mucosal fibroid, cesarean scar defects, endometrial hyperplasia, endometrial fluid accumulation, endometrial adhesion.
  • Participating in another IVF study at the same time

Treatment and study plan

Micronized progesterone

Drug

Progesterone will be started when endometrial thickness reached 8 mm or more. Patients will receive micronized progesterone (Cyclogest® 400mg; Actavis) at the dose of 400mg twice daily (morning and evening). A maximum of 2 embryos will be thawed on the day of embryo transfer, which is four days or six days after the start of progesterone depending on day-3 or day-5 embryo transfer. After thawing, surviving embryos will be transferred into the uterus under ultrasound guidance. Estradiol and progesterone will be continued until the day of pregnancy test. If the pregnancy test is positive, the patients will continue to use 800 mg micronized progesterone until 7 weeks of gestation.

Other names: Cyclogest 400mg

Micronized progesterone plus dydrogesterone

Drug

Progesterone will be started when endometrial thickness reached 8 mm or more. Patients will receive micronized progesterone (Cyclogest® 400mg; Actavis) at the dose of 400mg twice daily (morning and evening) plus dydrogesterone (Duphaston® 10mg, Abbott) at the dose of 10mg twice daily (morning and evening). A maximum of 2 embryos will be thawed on the day of embryo transfer, which is four days or six days after the start of progesterone depending on day-3 or day-5 embryo transfer. After thawing, surviving embryos will be transferred into the uterus under ultrasound guidance. Estradiol and progesterone will be continued until the day of pregnancy test. If the pregnancy test is positive, the patients will continue to use 800 mg micronized progesterone plus 20 mg dydrogestetrone until 7 weeks of gestation.

Other names: Cyclogest 400 mg + Duphaston 10 mg

Primary outcomes

  1. Live birth rate

    Time frame: At least 24 weeks of gestation up to the time of delivery

    The birth of at least one newborn after 24 weeks of gestation that exhibits any sign of life such as respiration, heartbeat, umbilical pulsation or movement of voluntary muscles (twin will be a single count).

Secondary outcomes

  1. The luteal progesterone level

    Time frame: On day four of the progesterone application

    The progesterone level in serum on day four after the progesterone application

  2. The length of luteal phase

    Time frame: On day sixteen of progesterone application

    Starting on the day of progesterone application and ending on the last day prior menses

  3. Positive pregnancy test rate

    Time frame: On day sixteen of progesterone application

    Serum human chorionic gonadotropin level greater than 5 mIU/mL after the completion of the first transfer

  4. Clinical pregnancy rate

    Time frame: At 7 weeks of gestation

    At least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity after the completion of the first transfer

  5. Ongoing pregnancy rate

    Time frame: At 12 weeks' gestation

    Pregnancy with detectable heart rate at 12 weeks' gestation or beyond after the completion of the first transfer.

  6. Implantation rate rate

    Time frame: At 3 weeks after embryo transferred

    The number of gestational sacs per number of embryos transferred after the completion of the first transfer.

  7. Ectopic pregnancy rate

    Time frame: At 12 weeks of gestation

    A pregnancy in which implantation takes place outside the uterine cavity

  8. Miscarriage rate

    Time frame: At 12 weeks of gestation

    Pregnancy loss at < 12 weeks

  9. Multiple pregnancy rate

    Time frame: At 7 weeks' gestation

    Presence of more than one sac at early pregnancy ultrasound (6-8 weeks of gestation)

  10. Gestational diabetes rate

    Time frame: At 24 weeks of gestation

    A type of diabetes that develop during pregnancy

  11. Hypertensive disorder of pregnancy rate

    Time frame: From 20 weeks of gestation up to at birth

    Comprising pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia

  12. Antepartum haemorrhage rate

    Time frame: From 24 weeks of gestation up to at birth

    Defined as bleeding from or in to the genital tract, occurring from 24 weeks of pregnancy and prior to the birth of the baby, including placenta previa, placenta accreta and unexplained

  13. Preterm delivery rate

    Time frame: At birth

    Defined as delivery at <24, <28, <32, <37 completed weeks

  14. Birth weight (grams) of singletons and twins

    Time frame: At birth

    Weight of baby born (grams)

  15. Low birth weight rate

    Time frame: At birth

    Weight of baby born < 2500 g at birth

  16. Very low birth weight rate

    Time frame: At birth

    Weight of baby born < 1500 g at birth

  17. High birth weight rate

    Time frame: At birth

    Weight of baby born >4000 gm at birth

  18. Very high birth weight rate

    Time frame: At birth

    Weight of baby born > 4500 gm at birth

  19. Congenital anomaly diagnosed at birth rate

    Time frame: At birth

    Any congenital anomalies detected in baby born

  20. Venous thromboembolism (VTE) rate

    Time frame: At 7 weeks of gestation

    Including deep venous thrombosis and pulmonary embolism

  21. Gastrointestinal disorders rate

    Time frame: At 7 weeks of gestation

    Including nausea, bloating, elevated liver enzymes

  22. Nervous system disorders rate

    Time frame: At 7 weeks of gestation

    Including headache, dizziness

  23. Vaginal discharge rate

    Time frame: At 7 weeks of gestation

    A fluid produced by glands in the vaginal wall and cervix that drains from the opening of the vagina

  24. Vaginal discomfort rate

    Time frame: At 7 weeks of gestation

    Including the symptoms of pain, itching, burning and swelling of vagina and vulva

  25. Vulvovaginal pruritus rate

    Time frame: At 7 weeks of gestation

    Itchiness of the vulva and vagina

Sponsors and collaborators

Lead sponsor

Mỹ Đức Hospital

Other

Registry information

Official study title

Micronized Progesterone Versus Micronized Progesterone Plus Dydrogesterone for Luteal Phase Support in Frozen - Thawed Transfer: a Prospective Cohort Study

Acronym: MiDRONE

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 26, 2019
Registry last updated
Feb 24, 2021

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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