CTRI/2019/10/021801已完成3 期
A Prospective, Randomized, Open-Label, Controlled, Clinical Study toCompare the Clinical Efficacy and Tolerability of Two Highly PurifiedHuman Menopausal Gonadotropin Preparations AdministeredSubcutaneously in Women Undergoing In Vitro Fertilization
Sanzyme P Ltd0 个研究点目标入组 156 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Women undergoing COS for their first or second cycle of IVF with or without intracytoplasmic sperm injection (ICSI) with following characteristics:
- •- Age > 21 and <= 40 years
- •- Ability to provide written informed consent voluntarily for study participation, along with consent by partner or spouse
- •- Body mass index between 18.5 and 30 kg/m2
- •- Basal FSH, LH, E2, P4 at luteal phase and prolactin (PRL) levels within normal range
- •- Normal antral follicle count (AFC) (6 to 10)
- •- Normal ovulatory cycles of 21 to 35 days inclusive
- •2. TVUS documenting the presence of both ovaries, without evidence of abnormality (e.g., no endometrioma) and normal adnexa (e.g., no
- •hydrosalpinx) within 6 months prior to randomization.
- •3. Normal or clinically insignificant haematology and blood chemistry values.
- •4. Husband/male partner with normal sperm motility and sperm count.
排除标准
- •1. History of more than 2 unsuccessful induction cycles with hMG or hCG regimen or intolerability to regimens requiring discontinuation.
- •2. Primary or secondary ovarian failure or women known as poor responders.
- •3. Patient with a history of >=3 miscarriages.
- •4. Presence of only one ovary or ovarian abnormality or ovarian cysts >10 mm in size for >1 cycle or ovarian endometrioma.
- •5. Patients with polycystic ovary syndrome.
- •6. Hydrosalpinx that have not been surgically removed or ligated.
- •7. Stage III or IV endometriosis.
- •8. Abnormality on endometrial biopsy.
- •9. Patients with submucosal fibroids >=5 cm or any other clinically relevant pathology, which could impair embryo implantation or pregnancy continuation
- •10. Tubal pathologies or history of ectopic pregnancy.
- •11. Prior history of OHSS.
- •12. Allergy, intolerance, or hypersensitivity to the study medication or its excipients.
- •13. Abnormal bleeding of undetermined origin.
- •14. Any history of malignancy or significant systemic disease (cardiovascular, gastrointestinal, pulmonary, neurological, or
- •autoimmune), endocrine or metabolic abnormalities (pituitary,thyroid, adrenal, pancreas, hepatic or renal), or any active condition requiring treatment, which, according to the investigator, might interfere with the study.
- •15. Metabolic disorders such as type I or type II diabetes mellitus.
- •16. Tumours and malformation of sexual organs incompatible with pregnancy.
- •17. Hyperprolactinaemia.
- •18. Women with severe infections of the reproductive system such as tuberculosis, sexually transmitted diseases, etc.
- •19. Known positive history of human immunodeficiency virus (HIV), hepatitis B or C, or syphilis.
- •20. Abnormality in the partnerâ??s semen based on semen analysis.
- •21. Use of concomitant medication that might interfere with ovulation (e.g., neuroleptics) or study evaluations, or concomitant
- •medications with known or suspected teratogenic agents (e.g., Food and Drug Administration Class X drugs).
- •22. Pregnancy, lactation, or contraindication to pregnancy.
- •23. Current or past (last 12 months) abuse of alcohol or drugs; women who smoke or have stopped smoking in the past 3 months.
- •24. Participation in a concurrent clinical trial or in another trial within the past 6 months.
研究者
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