A Prospective, Multicenter, open, Phase IV Clinical Trial to test efficacy and safety of Highly Purified Follicle-Stimulating Hormone in subjects Undergoing assisted reproductive Technique (ART)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- 2. Total dose of foliculin HP received.
研究概览
简要总结
STUDY SUMMARYxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /Name of Sponsor Company: Bharat Serums and Vaccines Ltd
Drug under Study: Foliculin HP (Highly purified follicle-stimulating hormone)
Title of Study: A prospective, multicenter, open, phase IV clinical trial to test efficacy and safety of highly purified follicle-stimulating hormone in subjects undergoing assisted reproductive techniques (ART).
Study Code: BSV/Foliculin-HP/12
Phase: IV
Indication: Induction of ovulation
Study Design: Prospective, Multicentric, Open-Label, Phase IV Study
Study Objectives:
1. Primary:
To assess the efficacy of Foliculin HP (Highly purified follicle-stimulating hormone) manufactured by Bharat Serums and Vaccines for ovulation induction in subjects undergoing ART.
2. Secondary:
To assess the safety of Foliculin HP (Highly purified follicle-stimulating hormone) manufactured by Bharat Serums and Vaccines Ltd for ovulation induction in subjects undergoing ART.
Patient Population: Adult women, aged 20 – 40 years (both inclusive), undergoing assisted reproduction technique at the time of enrollment.
Total Subjects (n): 200
Study Centres: 2-5 centres in India.
Study Treatment:
1 to 4 vials of 75 IU Foliculin HP (Highly purified follicle-stimulating hormone, manufactured by Bharat Serums and Vaccines Limited) will be administered subcutaneously per day for about 6- 12 days
Route of Administration: Subcutaneous (SC)
Treatment Duration: 6 - 12 days
Inclusion Criteria:
The following criteria should be checked at the time of study entry. If any does not apply at the time of study entry, the subject must not be included in the study.
1. Subjects undergoing ovulation induction with injectable HP FSH
2. Subject aged > 20 or ≤ 40 years (both inclusive).
3. BMI between 18 and 30 kg/m2
4. Normogonadotrophic subjects with normal (< 10 mIU/ml) FSH.
5. Male partner with semen parameters compatible with ART using ejaculated sperm.
6. Normal uterine cavity and at least one normal tube confirmed on 3D US and HycoSy or HSG &/or Laparoscopy within 3 years before recruitment.
7. Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality (e.g. no endometrioma) and normal adnexa (e.g. no hydrosalpinx) within 6 months before recruitment.
8. Signed informed consent form before screening
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If any of these apply at the time of study entry, the subject must not be included in the study:
1. Subjects < 20 or > 40 years of age.
2. Infertility attributable to severe endometriosis (grade III or IV).
3. Subjects whose male partner needs surgical sperm retrieval.
4. Pelvic pathology that would compromise ART success
5. Any chronic systemic disease including uncorrected hyperthyroid, hypothyroid and hyper
prolactinemia.
6. Pregnancy, lactation or contraindication to pregnancy
7. Current or past (last 12 months) abuse of alcohol or drugs
8. Undiagnosed vaginal bleeding
9. Tumors of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnancy
10. Hypersensitivity to any trial product
Criteria for Efficacy & Safety Evaluation:
Efficacy Criteria
This shall be assessed using following parameters:
Primary endpoints for efficacy
1. Total number of follicles ≥ 16 mm in diameter.
2. Total Dose of Foliculin HP received.
3. Total days of stimulation with Foliculin HP required to achieve Follicle size ≥ 16 mm in diameter.
Secondary endpoints for efficacy
1. Chemical pregnancy rate
2. Clinical pregnancy rate
Safety Criteria:
Incidence and absolute frequency of AE’s reported in trial which are related to study drug.
Statistical Analysis:
Qualitative data will be represented in form of frequency and percentage. Quantitative data will be represented using Mean± SD and Median & IQR (Interquartile range).
Data will be graphically represented where deemed necessary
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subject undergoing ovulation induction with injectable HP FSH
- •Subject age > 20 or ≤40 years (Both Inclusive)
- •BMI between 18 to 30 kg/m2
- •Normogonadotrophic subjects with normal (< 10 mIU/ml)FSH
- •Male partner with semen parameters compatible with ART using ejaculated sperm.
- •Normal uterine cavity and at least one normal tube confirmed on 3D US and HycoSy or HSG &/or Laproscopy within 3 yars before recruitment.
- •Transvaginal ultrasound documenting the presence of two ovaries, without of abnormality (e.g. no endometrioma) and normal adnexa (e.g. no hydrosalphinx)within 6 months before recruitment.
- •Signed Informed consent form before screening.
排除标准
- •Subject 20 or 40 years of age.
- •Infertility attributable to severe endometriosis (grade III or IV)
- •Subjects whose male partner needs surgical sperm retrieval.
- •Pelvic pathology that would compromise ART success.
- •Any chronic systemic disease including uncorrected hyperthyroid, hypothyroid and hyperprolactinemia
- •Pregnancy, lactation or contraindication to pregnancy.
- •Current or past (last 12 months)abuse of alcohol or drugs.
- •Undiagnosed vaginal bleeding.
- •tumors of the ovary, breast, adrenal gland, pituitary or hypothalamus and malformation of sexual organs incompatible with pregnancy.
- •Hypersensitivity of any trial product.
结局指标
主要结局
2. Total dose of foliculin HP received.
时间窗: 6 to 12 days
1. Total number of follicles ≥ 16mm in diameter.
时间窗: 6 to 12 days
3.Total days of stimulation with foliculin HP required to achieve follicle size ≥ 16 mm in diameter.
时间窗: 6 to 12 days
次要结局
- 1. Chemical pregnancy rate(2. Clinical pregnancy rate)