Growth Hormone in Poor Responders to IVF Trial

This study is currently recruiting participants.

Verified January 2013 by Pacific Centre for Reproductive Medicine

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: January 7, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 10, 2012

Last Updated Date

January 7, 2013

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01616225 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Growth Hormone in Poor Responders to IVF Trial

Official Title ^ICMJE

Adjuvant Growth Hormone in Infertile Women With Prior Poor IVF Response: a Randomized, Controlled, Open-label Study

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Infertility

Intervention ^ICMJE

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.
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.
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.

Study Arm (s)

Active Comparator: No Growth Hormone Supplementation
Intervention: Drug: No Saizen Control (Standard IVF Protocol)
Experimental: Luteal Growth Hormone Start
Growth hormone starting in the luteal phase of the previous menstrual cycle.

Intervention: Drug: Saizen (Human Growth Hormone)
Experimental: Follicular Growth Hormone Start
Starting growth hormone during the follicular phase of the prior menstrual cycle.

Intervention: Drug: Saizen (Human Growth Hormone)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2014

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 44 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jeffrey E Roberts, M.D.	604-422-7276	jroberts@pacificfertility.ca
Contact: Heather Abbey, R.N.	604-422-7276	habbey@pacificfertility.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01616225

Other Study ID Numbers ^ICMJE

PCRM-001

Has Data Monitoring Committee

Responsible Party

Pacific Centre for Reproductive Medicine

Study Sponsor ^ICMJE

Pacific Centre for Reproductive Medicine

Collaborators ^ICMJE

EMD Serono

Investigators ^ICMJE

Not Provided

Information Provided By

Pacific Centre for Reproductive Medicine

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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