The effect of using Growth Hormone in Invitro Fertilisation on livebirth rates

Phase 3

Recruiting

• Conditions: infertility; poor response to ovarian stimulation in IVF cycle; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12609001060235
• Lead Sponsor: Robinson Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 389

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified