Growth Hormone for Poor Responders in in Vitro Fertilization (IVF)

NCT01204840 | Completed Phase 2 DMC

• 1 other identifier: OFC-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if growth hormone given 4 weeks before as well as during a cycle of in vitro fertilization will improve outcomes in women who have had previous failure with IVF treatment cycles using high doses of follicle stimulating medications and had a poor response (less than 6 follicles).

Conditions

Infertility; Poor Ovarian Reserve

Keywords

in vitro fertilization; IVF; poor responder; growth hormone; Poor responders to in vitro fertilization treatments

Outcome Measures

Primary Outcomes (1)

• number of mature oocytes retrieved

  8-12 weeks from IVF start date

Secondary Outcomes (7)

• duration of stimulation

  8-12 weeks from IVF start date

• gonadotropin requirements

  8-12 weeks from IVF start date

• number of cumulus-oocyte complexes retrieved

  8-12 weeks from IVF start date

• number of fertilized oocytes

  8-12 weeks from IVF start date

• proportion of patients reaching embryo transfer

  8-12 weeks from IVF start date

Study Arms (2)

Group A - Control group

ACTIVE COMPARATOR

Group A (n=10; control group) will receive the "patch protocol" consisting of the 100ug estrogen patch (Estradot), a Gonadotropin Releasing Hormone (GnRH) antagonist (Cetrotide; 0.25mg/d), and gonadotropin stimulation with 412 IU of recombinant follicle stimulating hormone (r-FSH; Gonal F) and 150 IU of recombinant luteinizing hormone (r-LH; Luveris).

Drug: Patch protocol

Group B - treatment group

EXPERIMENTAL

Group B will consist of 30 subjects. In addition to the same hormone stimulation "patch protocol" as Group A, subjects will be treated with growth hormone 10 IU (3.33mg) per day by subcutaneous injection starting day 1 of the last menstrual period in the month prior to gonadotropin stimulation, and will continue daily until the day of human chorionic gonadotropin (hCG) injection.

Drug: Growth Hormone

Interventions

Growth Hormone DRUG

Subjects in this trial will use a 3.33mg vial (1 vial =10 IU) by daily subcutaneous injection. This will start on day 1 of the menstrual cycle preceding the stimulation phase of an IVF cycle, and will continue until the day of the human chorionic gonadotropin (hCG) trigger (approximately 5-6 weeks)

Also known as: Saizen (Somatoptropin; Human growth hormone)

Group B - treatment group

Patch protocol DRUG

Group A (n=10; control group) will receive "patch protocol": 100ug estrogen patch (Estradot), Gonadotropin releasing hormone (GnRH) antagonist (Cetrotide; 0.25mg/d), gonadotropin stimulation 412 IU recombinant follicle stimulating hormone (r-FSH; Gonal F) and 150 IU of recombinant luteinizing hormone (r-LH; Luveris). With 3 or more follicles at mean diameter equal to or greater than 17mm, urinary human chorionic gonadotropin (u-hCG) 10,000 IU self-injected to complete final maturation of oocytes. Egg retrieval will occur 36 hours after hCG injection. Eggs fertilized by standard IVF or intra-cytoplasmic sperm injection (ICSI) depending on semen parameters. Embryos cultured to day 2 and the best 2-4 will be transferred back under ultrasound guidance. Surplus embryos will be frozen as per clinic protocol. Luteal support: Endometrin 100mg vaginally three times daily, starting on the day of egg retrieval and continuing until menses or positive serum beta-hCG, then stopped.

Group A - Control group

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• less than 42 years of age
• previous IVF cycle with high doses of gonadotropins (defined as greater than or equal to 400 IU/day)
• produced less than 6 follicles greater than or equal to 15mm

You may not qualify if:

• any known contraindications to the approved fertility drugs as per the Canadian Product Monographs
• any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment), or are at risk for gestational diabetes

Sponsors & Collaborators

• Ottawa Fertility Centre: lead
• EMD Serono: collaborator

Study Sites (1)

Ottawa Fertililty Centre

Ottawa, Ontario, K2C 3V4, Canada

Location

Related Links

• Ottawa Fertility Centre webpage

MeSH Terms

Conditions

Infertility

Interventions

Growth Hormone; Human Growth Hormone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Arthur Leader, BSc., MD, FRCSC

  Ottawa Fertility Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 17, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

CA (1)