Progesterone Versus Progesterone Plus Dydrogesterone in FET
- Conditions
- Infertility
- Interventions
- Registration Number
- NCT03998761
- Lead Sponsor
- Mỹ Đức Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1364
- Undergoing frozen embryo transfer
- Endometrial prepared by exogenous hormonal regimen
- Permanent resident in Vietnam
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Micronized progesterone plus dydrogesterone 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, Abbott) at the dose of 10mg twice daily (morning and evening). Micronized progesterone Micronized Progesterone Patients will receive micronized progesterone (Cyclogest® 400mg; Actavis) at the dose of 400mg twice daily (morning and evening).
- Primary Outcome Measures
Name Time Method Live birth rate 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 Outcome Measures
Name Time Method The luteal progesterone level On day four of the progesterone application The progesterone level in serum on day four after the progesterone application
Gestational diabetes rate At 24 weeks of gestation A type of diabetes that develop during pregnancy
Antepartum haemorrhage rate 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
Ectopic pregnancy rate At 12 weeks of gestation A pregnancy in which implantation takes place outside the uterine cavity
Birth weight (grams) of singletons and twins At birth Weight of baby born (grams)
Low birth weight rate At birth Weight of baby born \< 2500 g at birth
Gastrointestinal disorders rate At 7 weeks of gestation Including nausea, bloating, elevated liver enzymes
Vulvovaginal pruritus rate At 7 weeks of gestation Itchiness of the vulva and vagina
The length of luteal phase On day sixteen of progesterone application Starting on the day of progesterone application and ending on the last day prior menses
Very high birth weight rate At birth Weight of baby born \> 4500 gm at birth
Venous thromboembolism (VTE) rate At 7 weeks of gestation Including deep venous thrombosis and pulmonary embolism
Positive pregnancy test rate On day sixteen of progesterone application Serum human chorionic gonadotropin level greater than 5 mIU/mL after the completion of the first transfer
Ongoing pregnancy rate At 12 weeks' gestation Pregnancy with detectable heart rate at 12 weeks' gestation or beyond after the completion of the first transfer.
Miscarriage rate At 12 weeks of gestation Pregnancy loss at \< 12 weeks
Multiple pregnancy rate At 7 weeks' gestation Presence of more than one sac at early pregnancy ultrasound (6-8 weeks of gestation)
Hypertensive disorder of pregnancy rate From 20 weeks of gestation up to at birth Comprising pregnancy induced hypertension (PIH); pre-eclampsia (PET) and eclampsia
High birth weight rate At birth Weight of baby born \>4000 gm at birth
Clinical pregnancy rate 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
Implantation rate rate At 3 weeks after embryo transferred The number of gestational sacs per number of embryos transferred after the completion of the first transfer.
Preterm delivery rate At birth Defined as delivery at \<24, \<28, \<32, \<37 completed weeks
Very low birth weight rate At birth Weight of baby born \< 1500 g at birth
Congenital anomaly diagnosed at birth rate At birth Any congenital anomalies detected in baby born
Nervous system disorders rate At 7 weeks of gestation Including headache, dizziness
Vaginal discharge rate At 7 weeks of gestation A fluid produced by glands in the vaginal wall and cervix that drains from the opening of the vagina
Vaginal discomfort rate At 7 weeks of gestation Including the symptoms of pain, itching, burning and swelling of vagina and vulva
Trial Locations
- Locations (1)
Mỹ Đức Hospital
🇻🇳Ho Chi Minh City, Tan Binh, Vietnam