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Growth Hormone in Poor Responders to IVF Trial

Primary Purpose

Infertility

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Saizen (Human Growth Hormone)

No Saizen Control (Standard IVF Protocol)

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, Poor Responder, In Vitro Fertilization, Growth Hormone

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Pacific Centre for Reproductive Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

No Growth Hormone Supplementation

Luteal Growth Hormone Start

Follicular Growth Hormone Start

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pregnancy rate

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.

Full Information

NCT ID

NCT01616225

First Posted

April 10, 2012

Last Updated

July 22, 2014

Sponsor

Pacific Centre for Reproductive Medicine

Collaborators

EMD Serono

1. Study Identification

Unique Protocol Identification Number

NCT01616225

Brief Title

Growth Hormone in Poor Responders to IVF Trial

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Terminated

Why Stopped

Insufficient/slow patient recruitment

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2015 (Anticipated)

Study Completion Date

August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pacific Centre for Reproductive Medicine

Collaborators

EMD Serono

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Infertility, Poor Responder, In Vitro Fertilization, Growth Hormone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

No Growth Hormone Supplementation

Arm Type

Active Comparator

Arm Title

Luteal Growth Hormone Start

Arm Type

Experimental

Arm Description

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

Arm Title

Follicular Growth Hormone Start

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Saizen (Human Growth Hormone)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Saizen (Human Growth Hormone)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

No Saizen Control (Standard IVF Protocol)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Oocyte yield

Description

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

Time Frame

Following course of treatment (2-3 weeks)

Secondary Outcome Measure Information:

Title

Pregnancy rate

Description

Time Frame

Approximately 2 weeks following completion of treatment.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

44 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Pacific Centre for Reproductive Medicine

City

Burnaby

State/Province

British Columbia

ZIP/Postal Code

V5G 4X7

Country

Canada

12. IPD Sharing Statement

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Growth Hormone in Poor Responders to IVF Trial

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