The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Percentage of Oocyte Maturation
研究概览
简要总结
We want to find out if kisspeptin is successful in stimulating oocyte maturation when it is used as a 'trigger' injection during IVF therapy for infertility.
详细描述
Participants in the study will have a standard Gonadotrophin Releasing Hormone (GnRH) antagonist IVF cycle, but instead of having a trigger injection of hCG (human chorionic gonadotrophin) they will be randomised to receive one of 4 doses of kisspeptin injection.
Oocytes will be retrieved and graded by an embryologist to see whether or not they have matured.
The reproductive hormones Luteinising hormone, follicle stimulating hormone, oestradiol and progesterone will also be measured
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
- Double (Participant, Care Provider)
盲法说明
participants and IVF physicians were blinded.
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 - 34 years
- •Body mass index between 18 and 29 kg/m2
- •Stable body weight for at least 3 months
- •Normal early menstrual cycle follicular phase serum FSH concentration
- •Serum anti-Mullerian hormone (AMH) > 40pmol/L
- •No more than one previous IVF treatment cycle
- •Both ovaries intact
排除标准
- •History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer
- •Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study
- •Treatment with an investigational drug within the preceding 2 months
- •Donated blood during the preceding 3 months or intention to do so before the end of the study
- •Previous poor response to IVF treatment
研究组 & 干预措施
Kisspeptin-54, 3.2 single
Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg
干预措施: Kisspeptin 3.2nmol/kg (Drug)
Kisspeptin-54, 1.6 single
Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 1.6 nmol/kg
干预措施: Kisspeptin 1.6nmol/kg (Drug)
Kisspeptin-54, 6.4 single
Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg
干预措施: Kisspeptin 6.4nmol/kg (Drug)
Kisspeptin-54, 12.8 single
Participant undergoing in vitro fertilisation (IVF) treatment will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg
干预措施: Kisspeptin 12.8nmol/kg (Drug)
Kisspeptin-54 OHSS, 3.2 single
Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 3.2 nmol/kg
干预措施: Kisspeptin 3.2nmol/kg (Drug)
Kisspeptin-54 OHSS, 6.4 single
Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 6.4 nmol/kg
干预措施: Kisspeptin 6.4nmol/kg (Drug)
Kisspeptin-54 OHSS, 9.6 single
Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 9.6 nmol/kg
干预措施: Kisspeptin 9.6nmol/kg (Drug)
Kisspeptin-54 OHSS, 12.8 single
Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a single trigger injection of Kisspeptin, dose of 12.8 nmol/kg
干预措施: Kisspeptin 12.8nmol/kg (Drug)
Kisspeptin-54 OHSS, 9.6 + 9.6
Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of Kisspeptin, dose of 9.6 nmol/kg 10 hours later
干预措施: Kisspeptin 9.6 nmol/kg double (Drug)
Kisspeptin-54 OHSS, 9.6 + saline
Participant undergoing in vitro fertilisation (IVF) treatment and who is at high risk of ovarian hyper stimulation syndrome (OHSS) will receive a trigger injection of Kisspeptin, dose of 9.6 nmol/kg and a further injection of saline10 hours later
干预措施: Kisspeptin 9.6 nmol/kg + saline (Drug)
结局指标
主要结局
Percentage of Oocyte Maturation
时间窗: 36 hours post Kisspeptin-54 trigger injection
This was assessed by oocyte yield (percentage of mature \[metaphase 2; M2\] oocytes collected from the number of follicles ≥ 14 mm on final ultrasound scan prior to kisspeptin-54 trigger administration
次要结局
- Biochemical Pregnancy(11 days after embryo transfer)
- Occurrence of OHSS(11 days following embryo transfer)
- Fertilization Rate(3 days after oocyte retrieval)
- Embryo Formation(3 days after oocyte retrieval)
- Number of Participants With Clinical Pregnancy(6 weeks after embryo transfer)