Growth Hormone in Poor Responders to IVF Trial

NCT01616225 | Terminated Phase 2

• 1 other identifier: PCRM-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Infertility; Poor Responder; In Vitro Fertilization; Growth Hormone

Outcome Measures

Primary Outcomes (1)

• Oocyte yield

  To assess the effect of adjuvant GH on the number of mature oocytes recovered from women undergoing COS using a GnRH antagonist protocol.

  Following course of treatment (2-3 weeks)

Secondary Outcomes (1)

• Pregnancy rate

  Approximately 2 weeks following completion of treatment.

Study Arms (3)

No Growth Hormone Supplementation

ACTIVE COMPARATOR

Drug: No Saizen Control (Standard IVF Protocol)

Luteal Growth Hormone Start

EXPERIMENTAL

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

Drug: Saizen (Human Growth Hormone)

Follicular Growth Hormone Start

EXPERIMENTAL

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

Drug: Saizen (Human Growth Hormone)

Interventions

Saizen (Human Growth Hormone) 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.

Luteal Growth Hormone Start

No Saizen Control (Standard IVF Protocol) 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.

No Growth Hormone Supplementation

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacific Centre for Reproductive Medicine: lead
• EMD Serono: collaborator

Study Sites (1)

Pacific Centre for Reproductive Medicine

Burnaby, British Columbia, V5G 4X7, Canada

Location

MeSH Terms

Conditions

Infertility

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: June 11, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

CA (1)