Growth Hormone in Poor Responders to IVF Trial

This study has been terminated.
(Insufficient/slow patient recruitment)
Sponsor:
Collaborator:
EMD Serono
Information provided by (Responsible Party):
Pacific Centre for Reproductive Medicine
ClinicalTrials.gov Identifier:
NCT01616225
First received: April 10, 2012
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: Saizen (Human Growth Hormone)
Drug: No Saizen Control (Standard IVF Protocol)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Growth Hormone in Infertile Women With Prior Poor IVF Response: a Randomized, Controlled, Open-label Study

Resource links provided by NLM:


Further study details as provided by Pacific Centre for Reproductive Medicine:

Primary Outcome Measures:
  • Oocyte yield [ Time Frame: Following course of treatment (2-3 weeks) ] [ Designated as safety issue: No ]
    To assess the effect of adjuvant GH on the number of mature oocytes recovered from women undergoing COS using a GnRH antagonist protocol.


Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: Approximately 2 weeks following completion of treatment. ] [ Designated as safety issue: No ]
    To assess the effect of adjuvant GH on: the proportion of subjects reaching embryo transfer; embryo quality; implantation rate; clinical pregnancy rate evaluated 5 weeks after IVF/ICSI (week 7 of gestation); proportion of subjects with clinical pregnancy; mean (SD) crown-rump length 5 weeks after IVF/ICSI (week 7 of gestation); proportion of subjects with a viable fetus(es) at week 12 of gestation; proportion of subjects with live births; duration of FSH stimulation; ampules of FSH consumed; and safety.


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: No Growth Hormone Supplementation 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.
Experimental: Luteal Growth Hormone Start
Growth hormone starting in the luteal phase of the previous menstrual cycle.
Drug: 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.
Experimental: Follicular Growth Hormone Start
Starting growth hormone during the follicular phase of the prior menstrual cycle.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT01616225

Locations
Canada, British Columbia
Pacific Centre for Reproductive Medicine
Burnaby, British Columbia, Canada, V5G 4X7
Sponsors and Collaborators
Pacific Centre for Reproductive Medicine
EMD Serono
  More Information

No publications provided

Responsible Party: Pacific Centre for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT01616225     History of Changes
Other Study ID Numbers: PCRM-001
Study First Received: April 10, 2012
Last Updated: July 22, 2014
Health Authority: Health Canada: Health Products and Food Branch

Keywords provided by Pacific Centre for Reproductive Medicine:
Infertility
Poor Responder
In Vitro Fertilization
Growth Hormone

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014