Trial record 4 of 96 for:    Open Studies | "Fertilization in Vitro"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Ottawa Fertility Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
EMD Serono
Information provided by:
Ottawa Fertility Centre
ClinicalTrials.gov Identifier:
NCT01204840
First received: September 14, 2010
Last updated: September 22, 2010
Last verified: September 2010
  Purpose

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).


Condition Intervention Phase
In Vitro Fertilization
Drug: Growth Hormone
Drug: Patch protocol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Co-treatment With Recombinant Growth Hormone (GH) in Poor Responders Treated by in Vitro Fertilization (IVF-ET)

Resource links provided by NLM:


Further study details as provided by Ottawa Fertility Centre:

Primary Outcome Measures:
  • number of mature oocytes retrieved [ Time Frame: 8-12 weeks from IVF start date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • duration of stimulation [ Time Frame: 8-12 weeks from IVF start date ] [ Designated as safety issue: No ]
  • gonadotropin requirements [ Time Frame: 8-12 weeks from IVF start date ] [ Designated as safety issue: No ]
  • number of cumulus-oocyte complexes retrieved [ Time Frame: 8-12 weeks from IVF start date ] [ Designated as safety issue: No ]
  • number of fertilized oocytes [ Time Frame: 8-12 weeks from IVF start date ] [ Designated as safety issue: No ]
  • proportion of patients reaching embryo transfer [ Time Frame: 8-12 weeks from IVF start date ] [ Designated as safety issue: No ]
  • implantation rate [ Time Frame: 8-12 weeks from IVF start date ] [ Designated as safety issue: No ]
  • clinical pregnancy rate [ Time Frame: 8-12 weeks from IVF start date ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A - Control group
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 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.
Experimental: Group B - treatment group
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
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)
Other Name: Saizen (Somatoptropin; Human growth hormone)

Detailed Description:

Growth hormone (GH; Saizen®) is indicated for the treatment of growth hormone deficiency in both children and adults, as well as for Turner's Syndrome, chronic renal failure, and children born short for gestational age.

In animal studies, growth hormone has been shown to be important in early antral follicle recruitment, subsequent follicular growth, and oocyte maturation. Together with insulin-like growth factor-1 (IGF-1), growth hormone is essential early on in the recruitment of primordial follicles in the growing pool (Slot et al 2006, Wandji et al 1992, Donadeu & Peterson 2008, Scaramuzi et al 2006, Liu et al, 1998).

Two recent meta-analyses have concluded that the addition of growth hormone during the ovarian stimulation phase of in vitro fertilization (IVF) cycles in poor responders will result in an increased probability of clinical pregnancy (Kolibianakas et al, 2009 and Ahmad et al, 2009). However, these studies have investigated the role of growth hormone in IVF when starting growth hormone injections with the initiation of gonadotropin stimulation. This may be too late to show an effect as GH may have more of an impact in the month prior to stimulation when primordial follicles are in the recruitment phase. Adding growth hormone in the month prior to stimulation with gonadotropins, as well as during stimulation phase may improve IVF outcomes by increasing the number of antral follicles that are recruited in the month prior to a stimulated cycle, and may ultimately improve the response to gonadotropin stimulation.

Starting growth hormone prior to stimulation has been studied in one previous publication (Kucuk et al, 2008), and showed that by starting growth hormone on day 21 of the menstrual cycle preceding gonadotropin stimulation, and continuing co-treatment with growth hormone until human chorionic gonadotropin (hCG) trigger resulted in a significantly higher number of fertilized oocytes when compared to a control group receiving no growth hormone (4.4 +/-1.8 vs 1.5 +/-0.9; p<0.001).

The addition of growth hormone to an IVF treatment protocol is directed at those infertile women who have previously undergone an IVF cycle on maximal doses of gonadotropins with a poor ovarian response. This study is aimed at improving IVF success in this population of women at the Ottawa Fertility Centre.

The purpose of this study is to determine if the addition of growth hormone both in the month prior to gonadotropin stimulation and during the active phase of stimulation, will result in an increased number of mature oocytes retrieved in previously poor responders during an IVF cycle.

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204840

Contacts
Contact: Arthur Leader, BSc., MD, FRCSC 613-686-3378 ext 624 aleader@conceive.ca

Locations
Canada, Ontario
Ottawa Fertililty Centre Recruiting
Ottawa, Ontario, Canada, K2C 3V4
Contact: Valerie Wilkie    613-686-3378 ext 620    vwilkie@conceive.ca   
Contact: Aaron Jackson, MD    819-918-9129    ajackson@conceive.ca   
Sub-Investigator: Aaron L Jackson, BSc., MD, FRCSC         
Sub-Investigator: Marie Claude Leveille, BSc., PhD         
Principal Investigator: Arthur Leader, BSc., MD, FRCSC         
Sponsors and Collaborators
Ottawa Fertility Centre
EMD Serono
Investigators
Principal Investigator: Arthur Leader, BSc., MD, FRCSC Ottawa Fertility Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Arthur Leader, Ottawa Fertility Centre
ClinicalTrials.gov Identifier: NCT01204840     History of Changes
Other Study ID Numbers: OFC-001
Study First Received: September 14, 2010
Last Updated: September 22, 2010
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Fertility Centre:
in vitro fertilization
IVF
poor responder
growth hormone
Poor responders to in vitro fertilization treatments

Additional relevant MeSH terms:
Chorionic Gonadotropin
Hormones
Follicle Stimulating Hormone
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014