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InfertilityPhase 2NCT01204840

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

A Phase 2 study testing Growth Hormone and Patch protocol in people with Infertility and Poor Ovarian Reserve, run by Ottawa Fertility Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 41 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Poor Ovarian Reserve
What is being tested?
Growth Hormone and Patch protocol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteCanada
Study dates
Sep 2010to May 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 41 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Ottawa Fertililty Centre

    Ottawa, Ontario, K2C 3V4

Other trials in Canada

About this study

Official title: Co-treatment With Recombinant Growth Hormone (GH) in Poor Responders Treated by in Vitro Fertilization (IVF-ET)

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).

Read the 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.

Being tested
Growth Hormone, Patch protocol
Keywords
in vitro fertilization, IVF, poor responder, growth hormone, Poor responders to in vitro fertilization treatments
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Growth HormoneDrug

    Also called Saizen (Somatoptropin; Human 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)

  • Patch protocolDrug

    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.

Study groups in NCT01204840
Study groupRoleWhat they receive
Group A - Control groupActive comparatorGroup 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).
Receives: Drug: Patch protocol
Group B - treatment groupExperimentalGroup 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.
Receives: Drug: Growth Hormone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of mature oocytes retrieved

    Measured: 8-12 weeks from IVF start date

Secondary outcomes (7)

  1. duration of stimulation

    Measured: 8-12 weeks from IVF start date

  2. gonadotropin requirements

    Measured: 8-12 weeks from IVF start date

  3. number of cumulus-oocyte complexes retrieved

    Measured: 8-12 weeks from IVF start date

  4. number of fertilized oocytes

    Measured: 8-12 weeks from IVF start date

  5. proportion of patients reaching embryo transfer

    Measured: 8-12 weeks from IVF start date

  6. implantation rate

    Measured: 8-12 weeks from IVF start date

  7. clinical pregnancy rate

    Measured: 8-12 weeks from IVF start date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01204840
Sponsor's protocol ID
OFC-001
Status last verified
Jun 2015
First submitted
14 Sep 2010
Last updated
1 Jul 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Growth Hormone and Patch protocol in people with Infertility and Poor Ovarian Reserve, run by Ottawa Fertility Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of mature oocytes retrieved (time frame: 8-12 weeks from IVF start date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01204840.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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