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临床试验/NCT04385342
NCT04385342Unknown4 期

Follicle Stimulating Hormone (FSH) Followed by Human Menopausal Gonadotropin (HMG) Versus FSH Plus HMG During Controlled Ovarian Stimulation for in Vitro Fertilization

Mansoura University3 个研究点 分布在 1 个国家目标入组 530 人开始时间: 2020年6月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
530
试验地点
3
主要终点
Ongoing pregnancy rate

研究概览

简要总结

The aim of this study is to compare the clinical outcomes of sequential administration of FSH and HP-hMG FSH alone versus concomitant administration of FSH and HP-hMG during controlled ovarian stimulation in IVF cycles.

详细描述

Women who are planned to be subjected to IVF/ICSI through COS by long GnRHa protocol will be assessed for possibility of participation in our study. Eligible participants in our study will be those with regular menstrual cycle (21-35 days) and normal uterine anatomy (confirmed by transvaginal ultrasound examination and in some cases hysteronsalpingography and hysteroscopy).

Women with any of the following criteria will be excluded from the study: 1) age < 20 or > 37 years; 2) body mass index (BMI) < 18 or > 25 kg/m2; 3) low ovarian reserve (AFC < 7 and/or AMH < 1.1 ng/ml); 4) presence of polycystic ovarian syndrome (PCOS), endometrioma or hydrosalpinx; 5) history of chemotherapy, radiotherapy or ovarian surgery; 6) the husband needs testicular biopsy to obtain sperm; or 7) previous implantation failure.

A written informed consent will be taken from each women selected to participate before inclusion in the study. All women participating in the study will start GnRHa on day 21 of the preceding cycle and when down regulation occurs each woman will be randomly allocated into one of the two groups; group 1 and group 2. Women in group 1 will receive 225 IU FSH alone from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm, the 150 IU HP-hMG will substitute FSH and continued to the day of triggering. Women in group 2 will receive 150 IU FSH plus 75 IU HP-hMG from day one of ovarian stimulation and 150IU HP-HMG when the follicular diameters reaches 10-12 mm till day of triggering. The randomization will be simple and balanced (1:1) and will be carried out by a nurse through sealed, unlabeled, opaque envelopes containing computer-generated random numbers. The data assesor will be blinded to group assignment.

In both groups, estradiol and LH will be measured on the third day of menstruation before start of stimulation and on day 6 of stimulation TVS will be performed. Progesterone and E2 will be measured and on day of triggering. The primary outcome measure of this study will be the ongoing pregnancy rate. The secondary outcomes measures will be cancellation rate, the number of oocytes retrieved, the number of embryos, the number of vitrified embryos, the clinical pregnancy rate, the implantation rate, OHSS rate, multiple pregnancy rate, and the miscarriage 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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who are planned to be subjected to IVF/ICSI through COS by long GnRHa protocol.
  • Women with regular menstrual cycle (21-35 days) and normal uterine anatomy (confirmed by transvaginal ultrasound examination and in some cases hysteronsalpingography and hysteroscopy).

排除标准

  • Age < 20 or > 37 years.
  • Body mass index (BMI) < 18 or > 30 kg/m
  • Low ovarian reserve (AFC < 7 and/or AMH < 1.1 ng/ml).
  • Presence of polycystic ovarian syndrome (PCOS).
  • Endometrioma or hydrosalpinx.
  • History of chemotherapy, radiotherapy or ovarian surgery.
  • The husband needs testicular biopsy to obtain sperm.
  • Previous implantation failure.

研究组 & 干预措施

FSH + HP-hMG

Active Comparator

Women will receive 150 IU FSH plus 75IU HP-hMG from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm 150 IU HP-HMG till day of triggering

干预措施: FSH (Drug)

FSH then HP-hMG

Active Comparator

Women will receive 225 IU FSH alone from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm, the 150 IU HP-hMG will substitute FSH and continued to the day of triggering

干预措施: FSH (Drug)

FSH then HP-hMG

Active Comparator

Women will receive 225 IU FSH alone from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm, the 150 IU HP-hMG will substitute FSH and continued to the day of triggering

干预措施: HP-hMG (Drug)

FSH + HP-hMG

Active Comparator

Women will receive 150 IU FSH plus 75IU HP-hMG from day one of ovarian stimulation and when the follicular diameters reaches 10-12 mm 150 IU HP-HMG till day of triggering

干预措施: HP-hMG (Drug)

结局指标

主要结局

Ongoing pregnancy rate

时间窗: 12 weeks gestational age

Number of ongoing pregnancies (defined as pregnancies passed beyond 12 weeks gestational age) divided by the number of women randomized

次要结局

  • Clinical pregnancy rate(6 weeks after embryo transfer)
  • Implantation rate(6 weeks after embryo transfer)
  • Miscarriage rate(12 weeks gestational age)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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