Effect of Highly Purified Menotrophin and Recombinant Follicle Stimulating (rFSH, Follitrophin Alpha) in Subfertile Female Patients Undergoing IVF on Progesterone Serum Levels During the Follicular Phase and Their Possible Use as Predictors for the Success Rate of Ongoing Pregnancies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 8
- 主要终点
- Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration
研究概览
简要总结
This study is aimed to demonstrate that highly purified Menotrophin produces significant lower progesterone serum levels during the follicular phase in comparison to Follitropin alpha in the treatment of subfertile females undergoing an in vitro fertilisation (IVF) and to investigate if the progesterone serum levels might be a useful predictor for the success rate of the ongoing pregnancy rates
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
- 34 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Subfertile premenopausal female patients eligible for in vitro fertilisation (IVF) treatment
- •Aged ≥34 and ≤42 years
- •Body mass index of >18 and <28 kg/m^2
- •Normal pelvic ultrasound at Screening
- •No more than two previous gonadotrophin stimulated cycles of IVF or intracytoplasmic sperm injection (ICSI) in the history of infertility treatment (gonadotrophin stimulated cycles not used for IVF or ICSI do not count; Clomifen cycles are no exclusion criterion)
- •At least 3 consecutive ovulatory menstrual cycles of 24-35 days
- •No fertility stimulating drugs at all
- •Sperm of partner classified as normal according to World Health Organisation (WHO) 2010 criteria
- •Clinically normal baseline haematology, clinical chemistry, and urinalysis values
- •Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within the last 6 months prior to Screening
- •Endocrine test results within the clinically normal limits at Screening
排除标准
- •Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus)
- •A history of or current endocrine disease (excluding treated hypothyreosis), including polycystic ovary syndrome (PCOS) and hyperprolactinaemia
- •A history of coagulation disorders
- •Persistent ovarian cysts (>3 months)
- •A history of hypersensitivity to any of the constituents of the study medication or related compounds
- •Diagnosed poor (<3 oocytes) responders to prior gonadotrophin stimulated ART-cycle
- •History of severe ovarian hyperstimulation syndrome in former gonadotrophin stimulated assisted reproductive technology (ART)-cycle
研究组 & 干预措施
Menotrophin
Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
干预措施: Menotrophin (Drug)
Menotrophin
Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
干预措施: Cetrorelix (Drug)
Menotrophin
Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
干预措施: Choriongonadotropin (Drug)
Menotrophin
Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
干预措施: Progesterone (Drug)
Follitrophin Alpha
Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
干预措施: Follitrophin alpha (Drug)
Follitrophin Alpha
Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
干预措施: Cetrorelix (Drug)
Follitrophin Alpha
Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
干预措施: Choriongonadotropin (Drug)
Follitrophin Alpha
Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
干预措施: Progesterone (Drug)
结局指标
主要结局
Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration
时间窗: approximately day 10
Ovulation induction was performed by administration of hCG once three follicles \>=17 mm diameter as shown by pelvic ultrasound examination. This outcome compares the serum progesterone level the morning prior to hCG administration across treatment arm, and also by age stratum (\<39 years and \>=39 years).
次要结局
- Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration(Day 7, approximately Day 10 (hCG Administration))
- Number of Follicles at hCG Administration(approximately day 10)
- Percentage of Participants With Ongoing Pregnancy(approximately 3.5 months from study start (at least 9 weeks after first positive pregnancy test))
- Average Follicle Diameter at hCG Administration(approximately day 10)
- Number of Cumulus-oocyte Complexes Retrieved(approximately day 12 after study start)
- Number of Pronuclear Oocytes(approximately day 13 after study start)
- Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade(approximately day 13)
- Number of Embryos Transferred(approximately day 14)
- Best Quality of an Embryo Transferred(approximately day 14)
- Number of Frozen Oocytes at Pronuclear Stage(approximately day 14)
- Endometrial Thickness on Day of hCG Administration(approximately day 10)
- Estradiol (E2) Levels on Day of hCG Administration(approximately day 10)
- Percentage of Participants With Successful Embryo Transfer(approximately day 18)
- Number of Days Stimulated With Gonadotrophins(Day 1 up to Day 12)
- Number of Ampoules of Gonadotrophins Used(Day 1 up to Day 12)
- Percentage of Participants With Clinical Pregnancy 6 Weeks After the First Positive Pregnancy Test(approximately 2.5 months from start of study, 6 weeks after first positive pregnancy test)
- Summary of Pregnancy Outcome(up to 10 months)