A Prospective Randomized Study of the Impact of Hormonal Monitoring and Progesterone Supplementation Adjustment on Outcome of Programmed Thawed Embryo Transfer Cycles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- live birth rate
研究概览
简要总结
Hormonal monitoring impact on overall pregnancy rate in frozen embryo transfer (FET)cycles and hence progesterone supplement adjustments remain debatable in current literature. This prospective randomized study aims to investigate the effect of monitoring and follow-up of serum progesterone, estradiol & luteinizing hormone (LH) levels and progesterone supplement adjustments on pregnancy outcomes for FET in programmed hormonal replacement therapy cycles in comparison with ultrasound only in control group
详细描述
Progesterone (P4) is a steroidal hormone that is required for successful embryo implantation and maintenance of the pregnancy in natural cycles, fresh in vitro fertilization cycles, and frozen embryo transfer (FET) cycles. Women undergoing FET in programmed cycle are unable to provide adequate endogenous P4 and require progesterone supplementation to initiate and maintain the secretory endometrium and pregnancy. There has been previous research into luteal phase support in frozen cycles, which has demonstrated that supplementation of progesterone does impact outcome in FET. Despite this evidence for the role of progesterone, there is surprisingly little data on the optimal values for serum P4 during the luteal phase and specifically on the day of embryo transfer in frozen cycles. Following years of a prevalent belief that the higher values of P4 are better, it seems that there may be an optimal window for P4 values during the luteal phase in bovine IVF. Though progesterone levels on the day of transfer have not yet been studied extensively in humans, tailoring the time of transferring a frozen embryo based on serial P4 values rather than cycle day number alone results in higher pregnancy rates. By direct action on the endometrium, a rise of LH might interfere with endometrial receptivity during a FET cycle, in which no pituitary suppression is used. The significance of LH level on the day before addition of progesterone is not yet well defined. The aim of this study is to investigate the effect of monitoring and follow-up of serum progesterone, estradiol & luteinizing hormone levels on day of embryo transfer on pregnancy outcomes for FET in programmed HRT cycles in comparison with ultrasound only in control group and to evaluate the effect of progesterone supplements adjustments depending on serum progesterone levels on day of FET in affecting clinical pregnancy rate.
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
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age of female patient 42 years or less
- •Normal uterine cavity
- •All embryos are day 5 or day 6 frozen blastocysts
排除标准
- •History of recurrent implantation failure
- •Previously known major thrombophilia factors
- •Non-compliance to given protocol
- •Endometrial thickness < 7mm after 13 days of priming with estradiol valerate
- •pre-existing metabolic diseases (Diabetes Mellitus & Hypertension).
研究组 & 干预措施
Group I (control)
All patients given 8 mg estradiol valerate orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle. Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation. In all Patients progesterone supplements in form of two vaginal prontogest suppositories 400 mg each. Transfer of frozen embryo will be done on day 5 after progesterone supplementation.
干预措施: estradiol valerate (Drug)
Group I (control)
All patients given 8 mg estradiol valerate orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle. Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation. In all Patients progesterone supplements in form of two vaginal prontogest suppositories 400 mg each. Transfer of frozen embryo will be done on day 5 after progesterone supplementation.
干预措施: transvaginal ultrasound examination (Diagnostic Test)
Group I (control)
All patients given 8 mg estradiol valerate orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle. Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation. In all Patients progesterone supplements in form of two vaginal prontogest suppositories 400 mg each. Transfer of frozen embryo will be done on day 5 after progesterone supplementation.
干预措施: Progesterone 400 Mg Vaginal Suppository (Drug)
group II (experimental)
All patients given 8 mg estradiol valerate orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle. Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation. In all Patients progesterone supplements in form of two vaginal prontogest suppositories 400 mg each. Transfer of frozen embryo will be done on day 5 after progesterone supplementation.
progesterone (P4) and estradiol assessed and Progesterone supplement adjustments based on serum level of P4 on day of embryo transfer dividing Group II (Cases) into 3 groups:
- Group II A: If P4 levels < 5ng/dl, one progesterone supplement in form of 100 mg intramuscular injection daily added
- Group II B: If P4 levels 5-10ng/dl, dydrogesterone three times daily added
- Group II C: If P4 levels >10ng, continue on 400 mg prontogest suppositories twice daily
干预措施: estradiol valerate (Drug)
group II (experimental)
All patients given 8 mg estradiol valerate orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle. Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation. In all Patients progesterone supplements in form of two vaginal prontogest suppositories 400 mg each. Transfer of frozen embryo will be done on day 5 after progesterone supplementation.
progesterone (P4) and estradiol assessed and Progesterone supplement adjustments based on serum level of P4 on day of embryo transfer dividing Group II (Cases) into 3 groups:
- Group II A: If P4 levels < 5ng/dl, one progesterone supplement in form of 100 mg intramuscular injection daily added
- Group II B: If P4 levels 5-10ng/dl, dydrogesterone three times daily added
- Group II C: If P4 levels >10ng, continue on 400 mg prontogest suppositories twice daily
干预措施: Hormonal monitoring progesterone, estradiol, luteinizing hormone (Other)
group II (experimental)
All patients given 8 mg estradiol valerate orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle. Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation. In all Patients progesterone supplements in form of two vaginal prontogest suppositories 400 mg each. Transfer of frozen embryo will be done on day 5 after progesterone supplementation.
progesterone (P4) and estradiol assessed and Progesterone supplement adjustments based on serum level of P4 on day of embryo transfer dividing Group II (Cases) into 3 groups:
- Group II A: If P4 levels < 5ng/dl, one progesterone supplement in form of 100 mg intramuscular injection daily added
- Group II B: If P4 levels 5-10ng/dl, dydrogesterone three times daily added
- Group II C: If P4 levels >10ng, continue on 400 mg prontogest suppositories twice daily
干预措施: transvaginal ultrasound examination (Diagnostic Test)
group II (experimental)
All patients given 8 mg estradiol valerate orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle. Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation. In all Patients progesterone supplements in form of two vaginal prontogest suppositories 400 mg each. Transfer of frozen embryo will be done on day 5 after progesterone supplementation.
progesterone (P4) and estradiol assessed and Progesterone supplement adjustments based on serum level of P4 on day of embryo transfer dividing Group II (Cases) into 3 groups:
- Group II A: If P4 levels < 5ng/dl, one progesterone supplement in form of 100 mg intramuscular injection daily added
- Group II B: If P4 levels 5-10ng/dl, dydrogesterone three times daily added
- Group II C: If P4 levels >10ng, continue on 400 mg prontogest suppositories twice daily
干预措施: Progesterone 400 Mg Vaginal Suppository (Drug)
group II (experimental)
All patients given 8 mg estradiol valerate orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle. Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation. In all Patients progesterone supplements in form of two vaginal prontogest suppositories 400 mg each. Transfer of frozen embryo will be done on day 5 after progesterone supplementation.
progesterone (P4) and estradiol assessed and Progesterone supplement adjustments based on serum level of P4 on day of embryo transfer dividing Group II (Cases) into 3 groups:
- Group II A: If P4 levels < 5ng/dl, one progesterone supplement in form of 100 mg intramuscular injection daily added
- Group II B: If P4 levels 5-10ng/dl, dydrogesterone three times daily added
- Group II C: If P4 levels >10ng, continue on 400 mg prontogest suppositories twice daily
干预措施: Hormonal monitoring progesterone and estradiol (Other)
group II (experimental)
All patients given 8 mg estradiol valerate orally on daily basis for 13 days beginning with the first day of either a spontaneously or induced menstrual cycle. Patients examined using transvaginal ultrasonography on day 13 of exogenous estrogen supplementation to measure endometrial thickness and to detect signs of escape ovulation. In all Patients progesterone supplements in form of two vaginal prontogest suppositories 400 mg each. Transfer of frozen embryo will be done on day 5 after progesterone supplementation.
progesterone (P4) and estradiol assessed and Progesterone supplement adjustments based on serum level of P4 on day of embryo transfer dividing Group II (Cases) into 3 groups:
- Group II A: If P4 levels < 5ng/dl, one progesterone supplement in form of 100 mg intramuscular injection daily added
- Group II B: If P4 levels 5-10ng/dl, dydrogesterone three times daily added
- Group II C: If P4 levels >10ng, continue on 400 mg prontogest suppositories twice daily
干预措施: Progesterone (Drug)
结局指标
主要结局
live birth rate
时间窗: assessed 26-40 weeks after embryo transfer
the number of live births (defined as at least one live born after 28 weeks of gestation) divided by the total number of patients who performed pregnancy tests
次要结局
- clinical pregnancy rate(assessed 4 weeks after embryo transfer)