Dydrogesterone Versus Micronized Vaginal Progesterone (MVP) for Luteal Phase Support (LPS) in Hormone Replacement Therapy (HRT) Frozen Embryo Transfer (FET) Cycles.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≤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.
排除标准
- •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
研究组 & 干预措施
Dydrogesterone
Luteal phase support for hormone replacement therapy frozen embryo transfer cycles using dydrogesterone 10 mg 3 times daily
干预措施: Dydrogesterone 10 MG Oral Tablet (Drug)
Micronized progesterone
Luteal phase support for hormone replacement therapy frozen embryo transfer cycles using micronized progesterone 2x200 mg twice daily vaginally
干预措施: Micronized progesterone (Drug)
结局指标
主要结局
Ongoing pregnancy
时间窗: 12 weeks
visualisation of a fetal heart activity via pelvic (vaginal/abdominal) ultrasound examination at 12 weeks of gestation.
次要结局
- Biochemical pregnancy rate(day 12-18 of luteal phase supplementation (pregnancy test))
- Blastocyst development score(at the time of embryo transfer (visit 2: day 6 of luteal phase supplementation))
- Incidence of newborn adverse events(follow-up time of 30 days after delivery)
- Clinical pregnancy rate(Day 33-39 of LPS (Verification of pregnancy))
- Rate of preterm birth(follow-up time of 30 days after delivery)
- Number of cryopreserved embryos(day of screening and enrollment)
- Implantation rate(Day 33-39 of LPS (Verification of pregnancy))
- Summary characteristics of the preceding controlled ovarian stimulation cycle(day of screening and enrollment)
- Live birth rate(22-42 weeks)
- Time of delivery(follow-up time of 30 days after delivery)
- Incidence of Treatment-Emergent Adverse Events(follow-up time of 30 days after delivery)
- Patient reported outcome(day 12-18 of luteal phase supplementation (pregnancy test) and at 12 weeks gestation)
- Rate of pre-eclampsia(follow-up time of 30 days after delivery)
- Miscarriage rate(22 weeks)
- Occurence of antenatal bleeding, ultrasonographic abnormalities, gestational diabetes, cholestasis(follow-up time of 30 days after delivery)
研究者
Caroline Roelens
Co-investigator
CRG UZ Brussel