NCT05403476终止2 期
A Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of FE 999049 for Treatment of Men With Idiopathic Infertility
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 23
- 主要终点
- Spontaneous pregnancy observed in female partner within 9 months after randomization of male subject, where spontaneous pregnancy is defined as vital pregnancy
研究概览
简要总结
The primary purpose of this trial is to investigate whether men with idiopathic infertility (unexplained reduction of semen quality), after being treated with a daily dose of 12 µg recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of spontaneous pregnancy observed in their female partners in comparison to placebo (inactive treatment). For more information, please visit the trial's website www.adamclinicaltrial.com (only applicable in the US).
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •History of infertility with current partner at randomisation must be 12-60 months if current partner is aged <35 years or 6-60 months if current partner is aged 35-38 years.
- •Men between the ages of 18 and 50 years.
- •Total sperm count 5-39 million at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomization.
- •Total sperm motility of ≥10% at screening; confirmed by two samples taken ≥2 weeks apart before randomisation. If a semen sample has been taken within 3 months prior to screening and been analysed at an andrology laboratory, it can be included as the first of the two semen samples at screening.
- •Semen volume ≥1.4 mL at screening; confirmed by two consecutive samples taken ≥2 weeks apart before randomization.
- •Serum follicle-stimulating hormone (FSH) levels of 2-12.0 IU/L (measured at central laboratory) at screening)
- •Serum luteinising hormone (LH) levels of 1.2-7.5 IU/L (measured at central laboratory) at screening.
- •Serum total testosterone levels of ≥300 ng/dL (equals ≥10.4 nmol/L; measured at central laboratory) at screening.
- •Agree to have regular intercourse with current female partner with the intent of spontaneous conception within 9 months from randomization.
- •Agree to provide information on female partner's positive urine pregnancy test(s) and documentation of ultrasound(s), delivery, and neonatal/infant health.
- •Current partner fulfilling the criteria below:
- •Pre-menopausal woman between the ages of 18 and 38 years (both inclusive) at the time of randomisation of male participant.
- •Regular menstrual cycles of 21-35 days.
- •No history or current condition of pelvic inflammatory disease, endometriosis stage II-IV by definite or empirical diagnosis, or tubal ligation.
- •Agree not to obtain infertility treatment outside of this trial for 6 months from randomization of male subject.
排除标准
- •Previous FSH treatment for ≥4 months not leading to conception.
- •Past or current use of finasteride within 3 months prior to screening.
- •Any history of anatomical disorder of the pituitary gland or testes.
- •Any structural abnormalities of the vas deferens (unilateral or bilateral) at screening.
- •Any known, clinically significant, systemic disease in addition to the trial indication that might negatively impact fertility.
- •Known history or presence of clinical varicocele (subclinical and Grade 1 varicocele are acceptable).
- •Known history of cryptorchidism, testicular torsion, or orchitis.
- •Known abnormal karyotype (including Y-chromosome microdeletion).
- •Current or past treatment of urogenital (kidney, bladder, testicular, or prostate) cancer as well as history of chemo- or radiotherapy that can have impact on testes.
- •Any known uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders).
- •Administration of hormonal preparations, agents known to impair testicular function or affect sex hormone secretion, and known or suspected teratogens within 3 months prior to screening. Administration of anabolic steroids within 12 months prior to screening.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
FE 999049 (Follitropin Delta)
Experimental
干预措施: FE 999049 (Drug)
结局指标
主要结局
Spontaneous pregnancy observed in female partner within 9 months after randomization of male subject, where spontaneous pregnancy is defined as vital pregnancy
时间窗: Up to 9 months after randomization
Vital pregnancy is documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound.
Spontaneous Pregnancy Observed in Female Partner Within 9 Months After Randomization of Male Subject, Where Spontaneous Pregnancy is Defined as Vital Pregnancy
时间窗: Up to 9 months after randomization
Vital pregnancy is documentation of at least one intrauterine gestational sac with fetal heartbeat by ultrasound.
次要结局
- Time from randomization to spontaneous pregnancy observed in female partner in calendar time and number of menstrual cycles(Up to 9 months (End-of-Trial))
- Changes in sperm concentration from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)
- Changes in luteinising hormone (LH) from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
- Changes in inhibin B from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
- Changes in testosterone from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
- Changes in estradiol from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
- Changes in total sperm count from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)
- Changes in total motile sperm count from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)
- Changes in follicle stimulating hormone (FSH) from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
- Changes in sperm morphology from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)
- Changes in semen DNA fragmentation from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)
- Treatment responders defined by either spontaneous pregnancy observed in female partner, or increase of total sperm count or total motile sperm count to 50% over average baseline at 6 and/or 9 months(Baseline to 6 and 9 months)
- Changes in free testosterone concentration from randomization to 3 and 6 months after randomization(From randomization to 3 and 6 months after randomization)
- Treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity(From randomization to 21-35 days after End-of-treatment)
- Immune-related adverse events(From randomization to End-of-Trial (up to 9 months))
- Positive Beta-Human Chorionic Gonadotropins (βhCG) (positive urine βhCG test) observed in female partner(Up to 9 months (End-of-Trial))
- Changes in semen volume from pre-randomization to 3, 6, and 9 months after randomization(From pre-randomization to 3, 6 and 9 months after randomization)
- Positive Beta-Human Chorionic Gonadotropins (βhCG) (Positive Urine βhCG Test) Observed in Female Partner(Up to 9 months (End-of-Trial))
- Time From Randomization to Spontaneous Pregnancy Observed in Female Partner.(9 months)
- Changes in Semen Volume From Pre-randomisation to 9 Months After Randomization(From pre-randomisation to end of trial (9 months))
- Changes in Sperm Concentration(From pre-randomization to end of trial (9 months))
- Changes in Total Sperm Count(From pre-randomisation to end of trial (9 months))
- Changes in Total Motile Sperm Count(From pre-randomisation to end of trial (9 months))
- Changes in Sperm Morphology(From pre-randomisation to end of trial (up to 9 months))
- Changes in Semen DNA Fragmentation(From pre-randomization to end of treatment)
- Treatment Responders Defined by Either Spontaneous Pregnancy Observed in Female Partner, or Increase of Total Sperm Count or Total Motile Sperm Count to 50% Over Average Baseline at 6 and/or 9 Months(Baseline to 6 and 9 months)
- Changes in Follicle Stimulating Hormone (FSH)(From randomization to 6 months after randomization)
- Changes in Luteinising Hormone (LH)(From randomisation to 3 and 6 months after randomization)
- Changes in Inhibin B(From randomization to 6 months after randomization)
- Changes in Testosterone(From randomization to 6 months after randomization)
- Changes in Estradiol(From randomization to 6 months after randomization)
- Changes in Free Testosterone Concentration(From randomization to 6 months after randomization)
- Number of Participants With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity(From randomization to 21-35 days after End-of-treatment (9 months))
- Number of Participants With Immune-related Adverse Events(From randomization to End-of-Trial (up to 9 months))
研究者
研究点 (23)
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