Growth Hormone in Poor Responders to IVF Trial

Pacific Centre for Reproductive Medicine

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Infertility

Treatments: Drug: No Saizen Control (Standard IVF Protocol); Drug: Saizen (Human Growth Hormone)

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT01616225

PCRM-001

Details and patient eligibility

About

This study (the "Adjuvant Growth Hormone Study") is being done to see the effects of adding Growth Hormone (GH) during fertility treatment (also called in vitro fertilization or IVF). Growth Hormone is a protein that your body normally produces. Growth Hormone can act on several different organs, including the ovaries, where eggs are made. From evidence gathered from studies done by fertility doctors over the years, researchers believe that women who have not become pregnant through IVF in the past might have better results if they go on a course of Growth Hormone during the IVF treatment. However, more research needs to be done to confirm whether adding Growth Hormone is beneficial and also to find out the best time to start Growth Hormone treatment during IVF.

We hope that our Adjuvant Growth Hormone study will help answer these questions.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject with prior poor response(s) to ovarian stimulation for IVF or ICSI. Poor response is defined as a history of producing fewer than four follicles ≥14 mm in diameter during previous COS cycles where FSH or HMG was used from cycle start at a daily dose of ≥450 IU
• Age ≤ 45 years
• Baseline blood labs, measured within previous month, show fasting blood glucose <6.1 mmol/L and TSH ≤ 5.5 mU/L
• Early follicular phase (Day 2 or Day 3) serum FSH, evaluated in the preceding 6 months
• Subject willing and able to give informed consent

Exclusion criteria

• Concurrently enrolled in any other clinical trial
• Previous participation in this study
• Using GnRH agonist in COS protocol
• Any prior early follicular phase serum FSH level ≥12 IU/L
• Use of any of the following is contraindicated or inappropriate: GH, Cetrotide®, FSH, LH or hCG
• Used OCP within the prior month
• Pregnant or lactating
• Untreated hydrosalpinx
• Tobacco smoker
• Diabetic or otherwise at risk of gestational diabetes
• BMI > 38 kg/m2
• Poorly controlled thyroid disease
• Known cancer or prior history of malignancies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

No Growth Hormone Supplementation

Active Comparator group

Treatment:

Drug: No Saizen Control (Standard IVF Protocol)

Luteal Growth Hormone Start

Experimental group

Description:

Growth hormone starting in the luteal phase of the previous menstrual cycle.

Treatment:

Drug: Saizen (Human Growth Hormone)

Drug: Saizen (Human Growth Hormone)

Follicular Growth Hormone Start

Experimental group

Description:

Starting growth hormone during the follicular phase of the prior menstrual cycle.

Treatment:

Drug: Saizen (Human Growth Hormone)

Drug: Saizen (Human Growth Hormone)