A randomised, double blind placebo controlled study assessing the effect of recombinant human growth hormone (r-hGH) on live birth rates in women who are poor responders undergoing an Invitro Fertilisation(IVF) or Intracytoplasmic Sperm Injection(ICSI) cycle.

Robinson Institute0 个研究点目标入组 389 人开始时间: 2009年12月10日最近更新: 2020年1月13日

适应症

试验速览

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•Have early follicular phase (Day 2-6) serum levels within the last 3 months prior to study entry of: FSH less than or equal to 15 IU/L and no recorded FSH level ever greater than 15IU/L
•Have a regular spontaneous menstrual cycle between 21 and 35 days in length.
•Have had a previous IVF/ICSI cycle resulting in collection of less than or equal to 5 oocytes.
•Be ordered a starting dose of ovarian stimulation of r-FSH of greater than or equal to 250 and less than or equal to 450 IU
•A body mass index (BMI) less than or equal to 32 kg/m2
•Have access to ejaculatory sperm. If not, the subject can only be entered if donor sperm will be used.
•Presence of both ovaries.
•Have a uterine cavity without abnormalities, which, in the investigator’s opinion, could impair embryo implantation or pregnancy evolution as assessed within the last 3 years using ultrasound (US), hysteroscopy (HSC), or hysterosalpingography (HSG).
•Have a negative cervical PAP test within the last 12 months prior to study entry, as evidenced by laboratory report in subject’s medical notes.
•have a normal fasting blood glucose level

•A history or current presence of Polycystic Ovarian Syndrome (PCOS) (Rotterdam criteria)
•Azoospermia requiring testicular sperm extraction
•Undergoing Preimplantation Genetic Screening during her IVF/ICSI cycle
•Previous chemotherapy and /or radiotherapy treatment
•Had previous severe ovarian hyper stimulation syndrome (OHSS).
•Any contraindication to being pregnant and/or carrying a pregnancy to term.
•A history of or current presence of tumours of the hypothalamus and pituitary gland.
•Current ovarian enlargement or ovarian cyst of unknown aetiology
•Current or past history of clinically significant systemic disease, including chronic kidney or liver disease, diabetes mellitus type I & II, uncontrolled thyroid disease, any autoimmune disease
•Current chronic infectious disease, including positive result for Hepatitis B, Hepatitis C, HumanImmunodeficency Virus (HIV)
•Acute or severe illness during the previous 6 months considered clinically significant according to clinician assessment
•Current or past history of malignancies including ovarian, uterine or breast cancer (except non-melanomatous skin malignancies)
•Abnormal gynaecological bleeding of undetermined origin
•Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years, according to clinical assessment including current smoking.

发起方

Robinson Institute