Growth Hormone in Poor Responders to IVF Trial

NCT ID: NCT01616225

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-08-31

Brief Summary

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No Growth Hormone Supplementation

Group Type: ACTIVE_COMPARATOR

No Saizen Control (Standard IVF Protocol)

Intervention Type: DRUG

All patients will be administered an oral contraceptive (Marvelon®). FSH treatment (daily subcutaneous injections of 450 IU Gonal-F®; Serono Canada) must begin 4 days after OCP stop, providing both of the following criteria are met. Pituitary downregulation with GnRH antagonist (Cetrotide®, Serono Canada) 0.25mg daily (subcutaneous injection) and LH (Luveris®, Serono Canada) 75 IU daily (subcutaneous injection) will be initiated when one or both of the following criteria are satisfied. Monitoring will continue until a lead follicle reaches ≥18 mm, at which time HCG (Ovidrel®, Serono Canada) 250 mcg will be administered by subcutaneous injection. Oocytes will be retrieved 36 hours after HCG treatment. Luteal support for the endometrium (90 mg progesterone (8% progesterone gel; Crinone® gel), administered intravaginally once daily) will begin one day after oocyte retrieval and will be maintained at least until day 31 of gestation.

Luteal Growth Hormone Start

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

Group Type: EXPERIMENTAL

Saizen (Human Growth Hormone)

Intervention Type: DRUG

Subjects will receive the standard protocol treatment, as well as adjuvant GH. One 3.33 mg vial Human Growth Hormone(10 IU Saizen®) will be self-administered daily by subcutaneous injection. GH treatment will start 14 days before FSH start and will continue until the day of the HCG treatment.

Follicular Growth Hormone Start

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

Group Type: EXPERIMENTAL

Saizen (Human Growth Hormone)

Intervention Type: DRUG

Subjects will receive the standard IVF treatment, as well as adjuvant GH as above. One 3.33 mg vial Human Growth Hormone(10 IU Saizen®) will be self-administered daily by subcutaneous injection. GH treatment will start on the same day as the FSH start and will continue until the day of HCG treatment.

Interventions

Saizen (Human Growth Hormone)

Subjects will receive the standard protocol treatment, as well as adjuvant GH. One 3.33 mg vial Human Growth Hormone(10 IU Saizen®) will be self-administered daily by subcutaneous injection. GH treatment will start 14 days before FSH start and will continue until the day of the HCG treatment.

Intervention Type: DRUG

Saizen (Human Growth Hormone)

Subjects will receive the standard IVF treatment, as well as adjuvant GH as above. One 3.33 mg vial Human Growth Hormone(10 IU Saizen®) will be self-administered daily by subcutaneous injection. GH treatment will start on the same day as the FSH start and will continue until the day of HCG treatment.

Intervention Type: DRUG

No Saizen Control (Standard IVF Protocol)

All patients will be administered an oral contraceptive (Marvelon®). FSH treatment (daily subcutaneous injections of 450 IU Gonal-F®; Serono Canada) must begin 4 days after OCP stop, providing both of the following criteria are met. Pituitary downregulation with GnRH antagonist (Cetrotide®, Serono Canada) 0.25mg daily (subcutaneous injection) and LH (Luveris®, Serono Canada) 75 IU daily (subcutaneous injection) will be initiated when one or both of the following criteria are satisfied. Monitoring will continue until a lead follicle reaches ≥18 mm, at which time HCG (Ovidrel®, Serono Canada) 250 mcg will be administered by subcutaneous injection. Oocytes will be retrieved 36 hours after HCG treatment. Luteal support for the endometrium (90 mg progesterone (8% progesterone gel; Crinone® gel), administered intravaginally once daily) will begin one day after oocyte retrieval and will be maintained at least until day 31 of gestation.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

EMD Serono

INDUSTRY

Sponsor Role: collaborator

Pacific Centre for Reproductive Medicine

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pacific Centre for Reproductive Medicine

Burnaby, British Columbia, Canada

Countries

Canada

Other Identifiers

PCRM-001

Identifier Type: -

Identifier Source: org_study_id