Female Infertility Due to Diminished Ovarian ReservePhase 1/2NCT02179255
Human Growth Hormone Pre-treatment for 6 Weeks Prior to Ovulation Induction for IVF
A Phase 1/2 study testing Human Growth Hormone and Follicle Stimulating Hormone in people with Female Infertility Due to Diminished Ovarian Reserve, run by Center for Human Reproduction at 1 site in United States.
Trial summary
Synthetic human growth hormone (HGH) has been available for more than a decade for specific indication in children and adults. Past Randomized Control Trials (RCT)s of HGH (under off-label use) for improving ovarian function have shown that a combination of traditional gonadotropin ovulation induction protocols, with… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Female Infertility Due to Diminished Ovarian Reserve
- What is being tested?
- Human Growth Hormone and Follicle Stimulating Hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2014to Jun 2022
- Phase
- Phase 1/2
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The study will be limited to women with Poor Response to prior treatment with evidence of diminished ovarian reserve with 2 or fewer oocytes in a previous ovulation induction cycles with maximal gonadotrophin stimulation. All women in this study will be <45 years old.
Who cannot join
- Cardiac disease, evidence of glucose intolerance
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Human Reproduction
New York, New York, 10021
About this study
Official title: An Open-Label Randomized Controlled Trial (RCT) of 6 Weeks of Human Growth Hormone (HGH) Prior to Ovulation Induction for In Vitro Fertilization (IVF)
Synthetic human growth hormone (HGH) has been available for more than a decade for specific indication in children and adults. Past Randomized Control Trials (RCT)s of HGH (under off-label use) for improving ovarian function have shown that a combination of traditional gonadotropin ovulation induction protocols, with addition of HGH is effective in increasing pregnancy rates, but not increasing egg production after IVF in women with documented diminished ovarian reserve (DOR). The investigators hypothesize that by initiating HGH at least 6 weeks prior to IVF start, the investigators will be able to increase production of oocytes and further improve pregnancy chances. This hypothesis is based on prior observations of effects of growth hormone on small antral follicles and the fact that prior studies utilized HGH principally only during ovulation induction itself.
The investigators plan to recruit 30 women (15 in each group) to an open label randomized controlled trial of HGH for augmentation of ovarian response among women with documented DOR and poor prior response to ovulation induction.
Read more
Eligible participants will be women < 45 years with documented history of prior retrieval of 2 or fewer oocytes while on maximal ovulation induction despite prior supplementation with dehydroepiandrosterone (DHEA).
Women will be treated with 1.9 mg (5.7 units) of HGH per day, beginning about 6 weeks before start of their treatment cycle. Cost of treatment with HGH will be a cost to the participating patient. HGH will cost the patient approximately $800 per week of treatment. Patients who are randomized to the non-HGH treated group, and do not conceive, will in the following cycle be offered HGH supplementation outside of this clinical trial. This subsequent cycle will not be part of the study dataset and patients will also be responsible for the cost of HGH.
Even with only 7 patients in each group, this trial will have a 99% power (error 0.05%) to detect a mean increase to 4 oocytes in the treated group. The investigators plan to recruit 15 patients in each group to allow for possible dropouts.
Read the detailed description
Synthetic HGH was developed in 1985 and approved by the FDA for specific uses in children and adults (1996; 2003). In children, HGH injections are approved for treating short stature of unknown cause as well as poor growth due to a number of medical causes, including:
- Turner's syndrome, a genetic disorder that affects a girl's development.
- Prader-Willi syndrome, an uncommon genetic disorder causing poor muscle tone, low levels of sex hormones, and a constant feeling of hunger.
- Chronic kidney insufficiency.
- HGH deficiency or insufficiency.
- Children born small for gestational age.
In adults, approved uses of HGH include:
- Short bowel syndrome, a condition in which nutrients are not properly absorbed due to severe intestinal disease or the surgical removal of a large portion of the small intestine.
- HGH deficiency due to rare pituitary tumors or their treatment.
- Muscle-wasting disease associated with HIV/AIDS.
HGH supplementation is potentially useful in ovulation induction. Over the last decade, as recombinant HGH has become commercially available, there have been many studies looking at the effects of HGH on ovulation induction. Almost all of these studies administered HGH along with routine fertility medication during the ovulation induction cycle. Most studies used HGH doses between 4 units and 12 Units. A few studies started GH on day 21 of the previous cycle.
A recent Cochrane review found that, while HGH did not improve results in routine IVF cycles there is "some evidence of increased pregnancy and birth rates in women who are considered 'poor responders' to in vitro fertilization."
HGH is reported to modulate the action of follicle stimulating hormone (FSH) on follicles by up-regulating local synthesis of IGF-1. A similar effect was, interestingly, noted by Casson et al. (Casson, Santoro et al. 1998; Casson, Lindsay et al. 2000) in early experiments using DHEA with treated patients having increased IGF-1. Much of the focus on gonadotropin /IGF-1
interaction has revolved around the effects on granulosa cell cultures to increase aromatase activity, estradiol production progesterone production and Luteinizing Hormone (LH) receptor formation. However,Insulin-Like Growth Factor-1 (IGF-1) also has a proposed role in stimulating early follicle development and oocyte maturation (Yoshimura, Ando et al. 1996; Yoshimura, Aoki et al. 1996).
Based on these observations, we believe that HGH in past trials has not been used to maximal effect. Since HGH, like DHEA, appears to affect small growing follicles, weeks to months removed from gonadotropin sensitivity, the greatest potential for HGH, under our hypothesis, would be its use, attempting to affect these small growing follicles. In analogy to DHEA supplementation, this would mean that HGH supplementation would have to be initiated at least 6 weeks prior to IVF cycle stimulation start. Theoretically, administration of HGH during the 6 week before starting an IVF cycle will have an effect on developing antral follicles to present a larger and better quality cohort of follicles when ovulation induction is begun.
- Being tested
- Human Growth Hormone, Follicle Stimulating Hormone
- Keywords
- DOR, Premature Ovarian Failure (POF), Ovarian Failure, Human Growth Hormone
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Growth HormoneDrug
Also called Human Growth Hormone (HGH), Somatotropin, Omnitrope, Norditropin
1.9 mg (5.7 units) daily injection of Recombinant Human Growth Hormone (HGH) for at least 6 weeks (42 days) continuing into the approximately 14 days of ovulation induction phase of the trial.
Follicle Stimulating HormoneDrug
Also called Bravelle, Follistim, Gonal-F, Menopure
FSH 450 to 600 units per day administered SQ daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger
| Study group | Role | What they receive |
|---|---|---|
| Human Growth Hormone | Experimental | 1.9 mg (5.7 units) daily injection of Recombinant Human Growth Hormone (HGH) for at least 6 weeks (42 days) plus FSH 450 to 600 units per day administered subcutaneous (SQ) daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger Receives: Drug: Human Growth Hormone; Drug: Follicle Stimulating Hormone |
| Follicle Stimulating Hormone | Active comparator | FSH 450 to 600 units per day administered SQ daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger Receives: Drug: Follicle Stimulating Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocytes retrieved for IVF
Measured: 8 weeks after starting intervention
Secondary outcomes (1)
Clinical Pregnancy Rates
Presence of an established clinical pregnancy as evidenced by gestational sac with active fetal heart beat
Measured: 12 weeks after starting intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study start1 Aug 2014
- Primary completionJun 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Female Infertility Due to Diminished Ovarian ReserveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Human Reproduction
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David H Barad, MD, Principal investigator, Center for Human ReproductionNorbert Gleicher, Study chair, Center for Human Reproduction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179255
- Sponsor's protocol ID
- 04082014-02
- Status last verified
- Feb 2020
- First submitted
- 15 Jun 2014
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
FDA approves human growth hormone for wasting syndrome. AIDS Patient Care STDS. 1996 Dec;10(6):379-80. No abstract available.
PubMed 11361571FDA approves growth hormone for short children. Child Health Alert. 2003 Sep;21:4. No abstract available.
PubMed 14552287Bergh C, Hillensjo T, Wikland M, Nilsson L, Borg G, Hamberger L. Adjuvant growth hormone treatment during in vitro fertilization: a randomized, placebo-controlled study. Fertil Steril. 1994 Jul;62(1):113-20.
PubMed 7516295Dor J, Seidman DS, Amudai E, Bider D, Levran D, Mashiach S. Adjuvant growth hormone therapy in poor responders to in-vitro fertilization: a prospective randomized placebo-controlled double-blind study. Hum Reprod. 1995 Jan;10(1):40-3. doi: 10.1093/humrep/10.1.40.
PubMed 7745068Suikkari A, MacLachlan V, Koistinen R, Seppala M, Healy D. Double-blind placebo controlled study: human biosynthetic growth hormone for assisted reproductive technology. Fertil Steril. 1996 Apr;65(4):800-5. doi: 10.1016/s0015-0282(16)58217-x.
PubMed 8654642Bergh C, Carlstrom K, Selleskog U, Hillensjo T. Effect of growth hormone on follicular fluid androgen levels in patients treated with gonadotropins before in vitro fertilization. Eur J Endocrinol. 1996 Feb;134(2):190-6. doi: 10.1530/eje.0.1340190.
PubMed 8630518Casson PR, Lindsay MS, Pisarska MD, Carson SA, Buster JE. Dehydroepiandrosterone supplementation augments ovarian stimulation in poor responders: a case series. Hum Reprod. 2000 Oct;15(10):2129-32. doi: 10.1093/humrep/15.10.2129.
PubMed 11006185Casson PR, Santoro N, Elkind-Hirsch K, Carson SA, Hornsby PJ, Abraham G, Buster JE. Postmenopausal dehydroepiandrosterone administration increases free insulin-like growth factor-I and decreases high-density lipoprotein: a six-month trial. Fertil Steril. 1998 Jul;70(1):107-10. doi: 10.1016/s0015-0282(98)00121-6.
PubMed 9660430Hazout A, Junca Am, Menezo Y, Demouzon J, Cohen-Bacrie P. Effect of growth hormone on oocyte competence in patients with multiple IVF failures. Reprod Biomed Online. 2009 May;18(5):664-70. doi: 10.1016/s1472-6483(10)60011-9.
PubMed 19549445Kucuk T, Kozinoglu H, Kaba A. Growth hormone co-treatment within a GnRH agonist long protocol in patients with poor ovarian response: a prospective, randomized, clinical trial. J Assist Reprod Genet. 2008 Apr;25(4):123-7. doi: 10.1007/s10815-008-9212-7.
PubMed 18392675Owen EJ, Shoham Z, Mason BA, Ostergaard H, Jacobs HS. Cotreatment with growth hormone, after pituitary suppression, for ovarian stimulation in in vitro fertilization: a randomized, double-blind, placebo-control trial. Fertil Steril. 1991 Dec;56(6):1104-10. doi: 10.1016/s0015-0282(16)54724-4.
PubMed 1743329Tesarik J, Hazout A, Mendoza C. Improvement of delivery and live birth rates after ICSI in women aged >40 years by ovarian co-stimulation with growth hormone. Hum Reprod. 2005 Sep;20(9):2536-41. doi: 10.1093/humrep/dei066. Epub 2005 Apr 28.
PubMed 15860489Yoshimura Y, Ando M, Nagamatsu S, Iwashita M, Adachi T, Sueoka K, Miyazaki T, Kuji N, Tanaka M. Effects of insulin-like growth factor-I on follicle growth, oocyte maturation, and ovarian steroidogenesis and plasminogen activator activity in the rabbit. Biol Reprod. 1996 Jul;55(1):152-60. doi: 10.1095/biolreprod55.1.152.
PubMed 8793070Demeestere I, Gervy C, Centner J, Devreker F, Englert Y, Delbaere A. Effect of insulin-like growth factor-I during preantral follicular culture on steroidogenesis, in vitro oocyte maturation, and embryo development in mice. Biol Reprod. 2004 Jun;70(6):1664-9. doi: 10.1095/biolreprod.103.023317. Epub 2004 Feb 11.
PubMed 14960488Yoshimura Y, Aoki N, Sueoka K, Miyazaki T, Kuji N, Tanaka M, Kobayashi T. Interactions between insulin-like growth factor-I (IGF-I) and the renin-angiotensin system in follicular growth and ovulation. J Clin Invest. 1996 Jul 15;98(2):308-16. doi: 10.1172/JCI118794.
PubMed 8755639
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Randomized Controlled Trial (RCT) of 6 Weeks of Human Growth Hormone (HGH) Prior to Ovulation Induction for In Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT02179255
- Acronym / sponsor ID
- 04082014-02
- Keywords
- DOR, Premature Ovarian Failure (POF), Ovarian Failure, Human Growth Hormone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Center for Human ReproductionUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Synthetic human growth hormone (HGH) has been available for more than a decade for specific indication in children and adults. Past Randomized Control Trials (RCT)s of HGH (under off-label use) for improving ovarian function have shown that a combination of traditional gonadotropin ovulation induction protocols, with addition of HGH is effective in increasing pregnancy rates, but not increasing egg production after IVF in women with documented diminished ovarian reserve (DOR). The investigators hypothesize that by initiating HGH at least 6 weeks prior to IVF start, the investigators will be able to increase production of oocytes and further improve pregnancy chances. This hypothesis is based on prior observations of effects of growth hormone on small antral follicles and the fact that prior studies utilized HGH principally only during ovulation induction itself.
The investigators plan to recruit 30 women (15 in each group) to an open label randomized controlled trial of HGH for augmentation of ovarian response among women with documented DOR and poor prior response to ovulation induction.
Eligible participants will be women < 45 years with documented history of prior retrieval of 2 or fewer oocytes while on maximal ovulation induction despite prior supplementation with dehydroepiandrosterone (DHEA).
Women will be treated with 1.9 mg (5.7 units) of HGH per day, beginning about 6 weeks before start of their treatment cycle. Cost of treatment with HGH will be a cost to the participating patient. HGH will cost the patient approximately $800 per week of treatment. Patients who are randomized to the non-HGH treated group, and do not conceive, will in the following cycle be offered HGH supplementation outside of this clinical trial. This subsequent cycle will not be part of the study dataset and patients will also be responsible for the cost of HGH.
Even with only 7 patients in each group, this trial will have a 99% power (error 0.05%) to detect a mean increase to 4 oocytes in the treated group. The investigators plan to recruit 15 patients in each group to allow for possible dropouts.
Detailed description
Synthetic HGH was developed in 1985 and approved by the FDA for specific uses in children and adults (1996; 2003). In children, HGH injections are approved for treating short stature of unknown cause as well as poor growth due to a number of medical causes, including:
- Turner's syndrome, a genetic disorder that affects a girl's development.
- Prader-Willi syndrome, an uncommon genetic disorder causing poor muscle tone, low levels of sex hormones, and a constant feeling of hunger.
- Chronic kidney insufficiency.
- HGH deficiency or insufficiency.
- Children born small for gestational age.
In adults, approved uses of HGH include:
- Short bowel syndrome, a condition in which nutrients are not properly absorbed due to severe intestinal disease or the surgical removal of a large portion of the small intestine.
- HGH deficiency due to rare pituitary tumors or their treatment.
- Muscle-wasting disease associated with HIV/AIDS.
HGH supplementation is potentially useful in ovulation induction. Over the last decade, as recombinant HGH has become commercially available, there have been many studies looking at the effects of HGH on ovulation induction. Almost all of these studies administered HGH along with routine fertility medication during the ovulation induction cycle. Most studies used HGH doses between 4 units and 12 Units. A few studies started GH on day 21 of the previous cycle.
A recent Cochrane review found that, while HGH did not improve results in routine IVF cycles there is "some evidence of increased pregnancy and birth rates in women who are considered 'poor responders' to in vitro fertilization."
HGH is reported to modulate the action of follicle stimulating hormone (FSH) on follicles by up-regulating local synthesis of IGF-1. A similar effect was, interestingly, noted by Casson et al. (Casson, Santoro et al. 1998; Casson, Lindsay et al. 2000) in early experiments using DHEA with treated patients having increased IGF-1. Much of the focus on gonadotropin /IGF-1
interaction has revolved around the effects on granulosa cell cultures to increase aromatase activity, estradiol production progesterone production and Luteinizing Hormone (LH) receptor formation. However,Insulin-Like Growth Factor-1 (IGF-1) also has a proposed role in stimulating early follicle development and oocyte maturation (Yoshimura, Ando et al. 1996; Yoshimura, Aoki et al. 1996).
Based on these observations, we believe that HGH in past trials has not been used to maximal effect. Since HGH, like DHEA, appears to affect small growing follicles, weeks to months removed from gonadotropin sensitivity, the greatest potential for HGH, under our hypothesis, would be its use, attempting to affect these small growing follicles. In analogy to DHEA supplementation, this would mean that HGH supplementation would have to be initiated at least 6 weeks prior to IVF cycle stimulation start. Theoretically, administration of HGH during the 6 week before starting an IVF cycle will have an effect on developing antral follicles to present a larger and better quality cohort of follicles when ovulation induction is begun.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Growth Hormone | Experimental | Drug: Human Growth Hormone, Drug: Follicle Stimulating Hormone1.9 mg (5.7 units) daily injection of Recombinant Human Growth Hormone (HGH) for at least 6 weeks (42 days) plus FSH 450 to 600 units per day administered subcutaneous (SQ) daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger |
| Follicle Stimulating Hormone | Active comparator | Drug: Follicle Stimulating HormoneFSH 450 to 600 units per day administered SQ daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study will be limited to women with Poor Response to prior treatment with evidence of diminished ovarian reserve with 2 or fewer oocytes in a previous ovulation induction cycles with maximal gonadotrophin stimulation. All women in this study will be <45 years old.
Key exclusion criteria (1 listed)
- Cardiac disease, evidence of glucose intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Growth HormoneAlso: Human Growth Hormone (HGH), Somatotropin, Omnitrope, Norditropin1.9 mg (5.7 units) daily injection of Recombinant Human Growth Hormone (HGH) for at least 6 weeks (42 days) continuing into the approximately 14 days of ovulation induction phase of the trial. | Drug | Human Growth Hormone |
| Follicle Stimulating HormoneAlso: Bravelle, Follistim, Gonal-F, MenopureFSH 450 to 600 units per day administered SQ daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger | Drug | Follicle Stimulating Hormone, Human Growth Hormone |
Primary outcome
Oocytes retrieved for IVF
Time frame: 8 weeks after starting intervention
1 secondary outcome
Clinical Pregnancy Rates
Time frame: 12 weeks after starting intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Background: PubMed 11361571FDA approves human growth hormone for wasting syndrome. AIDS Patient Care STDS. 1996 Dec;10(6):379-80. No abstract available.
- Background: PubMed 14552287FDA approves growth hormone for short children. Child Health Alert. 2003 Sep;21:4. No abstract available.
- Background: PubMed 7516295Bergh C, Hillensjo T, Wikland M, Nilsson L, Borg G, Hamberger L. Adjuvant growth hormone treatment during in vitro fertilization: a randomized, placebo-controlled study. Fertil Steril. 1994 Jul;62(1):113-20.
- Background: PubMed 7745068Dor J, Seidman DS, Amudai E, Bider D, Levran D, Mashiach S. Adjuvant growth hormone therapy in poor responders to in-vitro fertilization: a prospective randomized placebo-controlled double-blind study. Hum Reprod. 1995 Jan;10(1):40-3. doi: 10.1093/humrep/10.1.40.
- Background: PubMed 8654642Suikkari A, MacLachlan V, Koistinen R, Seppala M, Healy D. Double-blind placebo controlled study: human biosynthetic growth hormone for assisted reproductive technology. Fertil Steril. 1996 Apr;65(4):800-5. doi: 10.1016/s0015-0282(16)58217-x.
- Background: PubMed 8630518Bergh C, Carlstrom K, Selleskog U, Hillensjo T. Effect of growth hormone on follicular fluid androgen levels in patients treated with gonadotropins before in vitro fertilization. Eur J Endocrinol. 1996 Feb;134(2):190-6. doi: 10.1530/eje.0.1340190.
- Background: PubMed 11006185Casson PR, Lindsay MS, Pisarska MD, Carson SA, Buster JE. Dehydroepiandrosterone supplementation augments ovarian stimulation in poor responders: a case series. Hum Reprod. 2000 Oct;15(10):2129-32. doi: 10.1093/humrep/15.10.2129.
- Background: PubMed 9660430Casson PR, Santoro N, Elkind-Hirsch K, Carson SA, Hornsby PJ, Abraham G, Buster JE. Postmenopausal dehydroepiandrosterone administration increases free insulin-like growth factor-I and decreases high-density lipoprotein: a six-month trial. Fertil Steril. 1998 Jul;70(1):107-10. doi: 10.1016/s0015-0282(98)00121-6.
- Background: PubMed 19549445Hazout A, Junca Am, Menezo Y, Demouzon J, Cohen-Bacrie P. Effect of growth hormone on oocyte competence in patients with multiple IVF failures. Reprod Biomed Online. 2009 May;18(5):664-70. doi: 10.1016/s1472-6483(10)60011-9.
- Background: PubMed 18392675Kucuk T, Kozinoglu H, Kaba A. Growth hormone co-treatment within a GnRH agonist long protocol in patients with poor ovarian response: a prospective, randomized, clinical trial. J Assist Reprod Genet. 2008 Apr;25(4):123-7. doi: 10.1007/s10815-008-9212-7.
- Background: PubMed 1743329Owen EJ, Shoham Z, Mason BA, Ostergaard H, Jacobs HS. Cotreatment with growth hormone, after pituitary suppression, for ovarian stimulation in in vitro fertilization: a randomized, double-blind, placebo-control trial. Fertil Steril. 1991 Dec;56(6):1104-10. doi: 10.1016/s0015-0282(16)54724-4.
- Background: PubMed 15860489Tesarik J, Hazout A, Mendoza C. Improvement of delivery and live birth rates after ICSI in women aged >40 years by ovarian co-stimulation with growth hormone. Hum Reprod. 2005 Sep;20(9):2536-41. doi: 10.1093/humrep/dei066. Epub 2005 Apr 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David H Barad, MD principal investigator
Center for Human Reproduction
Norbert Gleicher study chair
Center for Human Reproduction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human Growth Hormone and Follicle Stimulating Hormone in people with Female Infertility Due to Diminished Ovarian Reserve, run by Center for Human Reproduction at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Feb 2020. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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?
Oocytes retrieved for IVF (time frame: 8 weeks after starting intervention). 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 NCT02179255, which also lists 17 linked publications.
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 18 Feb 2020.