InfertilityNCT03098199
AMH and Dosing Regimens for Initial IVF Stimulation Protocols
A study testing 300IU Gonal-F, 150IU Menopur and 225IU Gonal-F in people with Infertility, run by Reproductive Specialists of New York.
Trial summary
This is a research study on a hormone in women called anti-mullerian hormone (AMH) an indicator of the amount of egg reserve in the ovaries. The research involves a blood draw to determine the AMH level. Read more about this study
- Who is it for?
- Ages 25 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- 300IU Gonal-F, 150IU Menopur and 225IU Gonal-F
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2015to 31 Dec 2017
- Phase
- Interventional
- 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 25 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- first cycle of IVF with transfer of fresh embryo
Who cannot join
- use of non-autologous oocytes; prior diagnosis of premature ovarian failure or diminished ovarian reserve; BMI>= 40; cryopreservation cycles; smokers; use of PGS/PGD; use of surgically retrieved sperm or patients with severe male factor; and oocyte- or embryo-banking cycles
About this study
This is a research study on a hormone in women called anti-mullerian hormone (AMH) an indicator of the amount of egg reserve in the ovaries. The research involves a blood draw to determine the AMH level. This knowledge will help the investigators decide a dosage of gonadotropins, the hormones used to stimulate the production of more than one egg for use in an in vitro fertilization (IVF) cycle. The amount of gonadotropin given has to be tailored to each individual participant. The investigators can use information about the participant and the hormone levels to determine this dosage and the chances of becoming pregnant as a result of IVF treatment. The reason the investigators are doing this research is to find out if basing the gonadotropin dosage solely on the participant's AMH level will give the investigators a better result than the previous method based on age and other hormone levels.
Read the detailed description
Background / Rationale Anti-Müllerian Hormone (AMH) has been established as a valuable biomarker of ovarian reserve. It is a glycoprotein produced by granulosa cells of the ovary; it regulates the development of the primary follicle while inhibiting further recruitment of other surrounding follicles. Day 3 FSH and basal antral follicle count have traditionally been used to assess ovarian reserve and while they remain excellent predictors of poor ovarian response, they have not been shown to predict IVF success rates. Given the association between AMH and ovarian reserve, it has been proposed that AMH level can be used to predict ovarian response to gonadotropin stimulation and also, IVF success rates. An inverse relationship between AMH and total gonadotropin dosage has previously been demonstrated. As such, the concept of tailoring stimulation protocols to the patient's potential for oocyte production based on AMH level has gained favor. Individualization allows the practitioner to use the minimum dosage of medication required for maximum response, while limiting the risk of ovarian hyperstimulation syndrome. The question becomes how to determine the dosage of medication required for each AMH level and what effect will this have on clinical outcomes?
Hypothesis 1) Knowledge of AMH level used to determine medication dosage at the start of the stimulation cycle will result in a higher oocyte yield at the time of retrieval, higher clinical pregnancy rate, and higher live birth rate.
- Knowledge of AMH level used to determine initial medication dosage at the start of the stimulation cycle will result in a fewer number of dosage changes mid-cycle.
- Knowledge of AMH level prior to the start of a stimulation cycle will result in the use of a different initial stimulation dose compared to cycles in which the AMH is unknown.
- Knowledge of AMH level used to determine medication dosage prior to the start of the stimulation cycle will result in a lower rate of ovarian hyperstimulation syndrome (OHSS). (Defined as >=20 oocytes/follicles) 5) Knowledge of AMH level used to determine medication dosage prior to the start of the stimulation cycle will result in a lower rate of cancelled cycles.
Methods and Procedures. The AMH level for all patients will be assessed at the initial fertility evaluation for each patient.
Patients will undergo controlled ovarian hyperstimulation (COH) with a GnRH antagonist protocol. They will begin COH on day 3 of their menstrual cycle or they may need to begin with approximately one week of oral contraceptives. After one week, the patients will stop taking oral contraceptives if their ovaries appear quiescent on transvaginal ultrasound and their serum E2 levels are low. These patients will then begin COH three days later. Gonadotropin dosage will be determined at the start of the cycle by AMH level.
Dosages will be adjusted, beginning on the third day of gonadotropins, based on clinical response, determined by serum hormone levels and transvaginal ultrasound of the ovaries throughout the cycle. The patient will begin taking the GnRH antagonist, Ganirelix or Cetrotide, when the lead follicle measures ≥14mm on transvaginal ultrasound. Patients will be triggered with Lupron, hCG, or both when the lead follicle measures ≥20mm on transvaginal ultrasound. All medications are administered via subcutaneous injections.
Transvaginal ultrasound-guided oocyte retrieval will be performed 36 hours after the trigger medication(s) is administered. Cycles with a poor ovarian response, defined as <3 follicles and/or a peak estradiol level <600 pg/mL, will be canceled.
Patients will undergo culture day 5 embryo transfer; number of embryos transferred will be according to ASRM guidelines. If the patient exhibits symptoms of OHSS, she will discontinue luteal phase support and will not have an embryo transfer, and all good quality blastocyst mbryos will be cryopreserved. All patients eligible for embryo transfer will continue the luteal phase support protocol until the serum hCG pregnancy test 14 days post-retrieval. If the serum hCG is <5 mIU/mL, luteal phase support will be discontinued. If the serum hCG is ≥5 mIU/mL, Estrace will continue to be taken until 8 weeks gestation and Endometrin or intramuscular progesterone in oil will continue to be used until 10 weeks gestation. At this point, patient is released to the care of the obstetrician. The patient or the obstetrician will be contacted for pregnancy outcome data.
- Conditions
- Infertility
- Being tested
- 300IU Gonal-F, 150IU Menopur, 225IU Gonal-F, 75IU Menopur, 150IU Gonal-F
- Keywords
- Antimullerian Hormone, In vitro fertilization, Medications, Dosing
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300IU Gonal-FDrug
Also called follitropin
<1.5 AMH group
150IU MenopurDrug
Also called menotropin
<1.5 AMH group
225IU Gonal-FDrug
1.6-2.5 AMH group
75IU MenopurDrug
1.6-2.5 AMH group 2.6-6.9 AMH group >7.0 AMH group
150IU Gonal-FDrug
2.6-6.9 AMH group
75IU Gonal-FDrug
>7.0 AMH group
| Study group | Role | What they receive |
|---|---|---|
| AMH<1.5, 300IU Gonal-F + 150 IU Menopur | Experimental | dosage at 300IU Gonal-F + 150IU Menopur Receives: Drug: 300IU Gonal-F; Drug: 150IU Menopur |
| AMH 1.6-2.5, 225IU Gonal-F+75IU Menopur | Experimental | dosage of 225IU Gonal-F + 75IU Menopur Receives: Drug: 225IU Gonal-F; Drug: 75IU Menopur |
| AMH 2.6-6.9, 150IU Gonal-F+75IU Menopur | Experimental | start dosage of 150IU Gonal-F and 75IU Menopur Receives: Drug: 75IU Menopur; Drug: 150IU Gonal-F |
| AMH >=7.0, 75IU Gonal-F+75U Menopur | Experimental | start dosage of 75IU Gonal-F and 75U Menopur Receives: Drug: 75IU Menopur; Drug: 75IU Gonal-F |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Clinical pregnancy rate is defined as the number of pregnancies with the presence of an intrauterine gestational sac seen on transvaginal ultrasound by six weeks gestation divided by the number of completed embryo transfers.
Measured: two years
Secondary outcomes (1)
Oocyte yield
number of follicles produced
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start22 Oct 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Specialists of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Sung, MD, Principal investigator, Reproductive Specialists of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098199
- Sponsor's protocol ID
- 597102-3
- Status last verified
- Apr 2018
- First submitted
- 1 Mar 2017
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anderson RA, Nelson SM, Wallace WH. Measuring anti-Mullerian hormone for the assessment of ovarian reserve: when and for whom is it indicated? Maturitas. 2012 Jan;71(1):28-33. doi: 10.1016/j.maturitas.2011.11.008. Epub 2011 Nov 26.
PubMed 22119275de Vet A, Laven JS, de Jong FH, Themmen AP, Fauser BC. Antimullerian hormone serum levels: a putative marker for ovarian aging. Fertil Steril. 2002 Feb;77(2):357-62. doi: 10.1016/s0015-0282(01)02993-4.
PubMed 11821097Freour T, Mirallie S, Colombel A, Bach-Ngohou K, Masson D, Barriere P. Anti-mullerian hormone: clinical relevance in assisted reproductive therapy. Ann Endocrinol (Paris). 2006 Dec;67(6):567-74. doi: 10.1016/s0003-4266(06)73008-6.
PubMed 17194966Gleicher N, Kim A, Weghofer A, Barad DH. Toward a better understanding of functional ovarian reserve: AMH (AMHo) and FSH (FSHo) hormone ratios per retrieved oocyte. J Clin Endocrinol Metab. 2012 Mar;97(3):995-1004. doi: 10.1210/jc.2011-2403. Epub 2011 Dec 14.
PubMed 22170712Jayaprakasan K, Campbell B, Hopkisson J, Johnson I, Raine-Fenning N. A prospective, comparative analysis of anti-Mullerian hormone, inhibin-B, and three-dimensional ultrasound determinants of ovarian reserve in the prediction of poor response to controlled ovarian stimulation. Fertil Steril. 2010 Feb;93(3):855-64. doi: 10.1016/j.fertnstert.2008.10.042. Epub 2008 Nov 30.
PubMed 19046583Kwee J, Schats R, McDonnell J, Themmen A, de Jong F, Lambalk C. Evaluation of anti-Mullerian hormone as a test for the prediction of ovarian reserve. Fertil Steril. 2008 Sep;90(3):737-43. doi: 10.1016/j.fertnstert.2007.07.1293. Epub 2007 Oct 17.
PubMed 17923131Panchal S, Nagori C. Comparison of anti-mullerian hormone and antral follicle count for assessment of ovarian reserve. J Hum Reprod Sci. 2012 Sep;5(3):274-8. doi: 10.4103/0974-1208.106340.
PubMed 23531919Tremellen KP, Kolo M, Gilmore A, Lekamge DN. Anti-mullerian hormone as a marker of ovarian reserve. Aust N Z J Obstet Gynaecol. 2005 Feb;45(1):20-4. doi: 10.1111/j.1479-828X.2005.00332.x.
PubMed 15730360van Rooij IA, Broekmans FJ, te Velde ER, Fauser BC, Bancsi LF, de Jong FH, Themmen AP. Serum anti-Mullerian hormone levels: a novel measure of ovarian reserve. Hum Reprod. 2002 Dec;17(12):3065-71. doi: 10.1093/humrep/17.12.3065.
PubMed 12456604Biasoni V, Patriarca A, Dalmasso P, Bertagna A, Manieri C, Benedetto C, Revelli A. Ovarian sensitivity index is strongly related to circulating AMH and may be used to predict ovarian response to exogenous gonadotropins in IVF. Reprod Biol Endocrinol. 2011 Aug 9;9:112. doi: 10.1186/1477-7827-9-112.
PubMed 21824441Choi MH, Yoo JH, Kim HO, Cha SH, Park CW, Yang KM, Song IO, Koong MK, Kang IS. Serum anti-Mullerian hormone levels as a predictor of the ovarian response and IVF outcomes. Clin Exp Reprod Med. 2011 Sep;38(3):153-8. doi: 10.5653/cerm.2011.38.3.153. Epub 2011 Sep 30.
PubMed 22384435Elgindy EA, El-Haieg DO, El-Sebaey A. Anti-Mullerian hormone: correlation of early follicular, ovulatory and midluteal levels with ovarian response and cycle outcome in intracytoplasmic sperm injection patients. Fertil Steril. 2008 Jun;89(6):1670-6. doi: 10.1016/j.fertnstert.2007.05.040. Epub 2007 Jul 20.
PubMed 17658520Honnma H, Baba T, Sasaki M, Hashiba Y, Oguri H, Fukunaga T, Endo T, Asada Y. Different ovarian response by age in an anti-Mullerian hormone-matched group undergoing in vitro fertilization. J Assist Reprod Genet. 2012 Feb;29(2):117-25. doi: 10.1007/s10815-011-9675-9. Epub 2011 Nov 16.
PubMed 22086616La Marca A, Giulini S, Tirelli A, Bertucci E, Marsella T, Xella S, Volpe A. Anti-Mullerian hormone measurement on any day of the menstrual cycle strongly predicts ovarian response in assisted reproductive technology. Hum Reprod. 2007 Mar;22(3):766-71. doi: 10.1093/humrep/del421. Epub 2006 Oct 27.
PubMed 17071823Muttukrishna S, McGarrigle H, Wakim R, Khadum I, Ranieri DM, Serhal P. Antral follicle count, anti-mullerian hormone and inhibin B: predictors of ovarian response in assisted reproductive technology? BJOG. 2005 Oct;112(10):1384-90. doi: 10.1111/j.1471-0528.2005.00670.x.
PubMed 16167941
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMH and Dosing Regimens for Initial IVF Stimulation Protocols
- ClinicalTrials.gov ID
- NCT03098199
- Acronym / sponsor ID
- 597102-3
- Conditions
- Infertility
- Keywords
- Antimullerian Hormone, In vitro fertilization, Medications, Dosing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Reproductive Specialists of New YorkUniversity, hospital or other
- Study start
- 22 Oct 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 31 Mar 2017 (actual)
- 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.
This is a research study on a hormone in women called anti-mullerian hormone (AMH) an indicator of the amount of egg reserve in the ovaries. The research involves a blood draw to determine the AMH level. This knowledge will help the investigators decide a dosage of gonadotropins, the hormones used to stimulate the production of more than one egg for use in an in vitro fertilization (IVF) cycle. The amount of gonadotropin given has to be tailored to each individual participant. The investigators can use information about the participant and the hormone levels to determine this dosage and the chances of becoming pregnant as a result of IVF treatment. The reason the investigators are doing this research is to find out if basing the gonadotropin dosage solely on the participant's AMH level will give the investigators a better result than the previous method based on age and other hormone levels.
Detailed description
Background / Rationale Anti-Müllerian Hormone (AMH) has been established as a valuable biomarker of ovarian reserve. It is a glycoprotein produced by granulosa cells of the ovary; it regulates the development of the primary follicle while inhibiting further recruitment of other surrounding follicles. Day 3 FSH and basal antral follicle count have traditionally been used to assess ovarian reserve and while they remain excellent predictors of poor ovarian response, they have not been shown to predict IVF success rates. Given the association between AMH and ovarian reserve, it has been proposed that AMH level can be used to predict ovarian response to gonadotropin stimulation and also, IVF success rates. An inverse relationship between AMH and total gonadotropin dosage has previously been demonstrated. As such, the concept of tailoring stimulation protocols to the patient's potential for oocyte production based on AMH level has gained favor. Individualization allows the practitioner to use the minimum dosage of medication required for maximum response, while limiting the risk of ovarian hyperstimulation syndrome. The question becomes how to determine the dosage of medication required for each AMH level and what effect will this have on clinical outcomes?
Hypothesis 1) Knowledge of AMH level used to determine medication dosage at the start of the stimulation cycle will result in a higher oocyte yield at the time of retrieval, higher clinical pregnancy rate, and higher live birth rate.
- Knowledge of AMH level used to determine initial medication dosage at the start of the stimulation cycle will result in a fewer number of dosage changes mid-cycle.
- Knowledge of AMH level prior to the start of a stimulation cycle will result in the use of a different initial stimulation dose compared to cycles in which the AMH is unknown.
- Knowledge of AMH level used to determine medication dosage prior to the start of the stimulation cycle will result in a lower rate of ovarian hyperstimulation syndrome (OHSS). (Defined as >=20 oocytes/follicles) 5) Knowledge of AMH level used to determine medication dosage prior to the start of the stimulation cycle will result in a lower rate of cancelled cycles.
Methods and Procedures. The AMH level for all patients will be assessed at the initial fertility evaluation for each patient.
Patients will undergo controlled ovarian hyperstimulation (COH) with a GnRH antagonist protocol. They will begin COH on day 3 of their menstrual cycle or they may need to begin with approximately one week of oral contraceptives. After one week, the patients will stop taking oral contraceptives if their ovaries appear quiescent on transvaginal ultrasound and their serum E2 levels are low. These patients will then begin COH three days later. Gonadotropin dosage will be determined at the start of the cycle by AMH level.
Dosages will be adjusted, beginning on the third day of gonadotropins, based on clinical response, determined by serum hormone levels and transvaginal ultrasound of the ovaries throughout the cycle. The patient will begin taking the GnRH antagonist, Ganirelix or Cetrotide, when the lead follicle measures ≥14mm on transvaginal ultrasound. Patients will be triggered with Lupron, hCG, or both when the lead follicle measures ≥20mm on transvaginal ultrasound. All medications are administered via subcutaneous injections.
Transvaginal ultrasound-guided oocyte retrieval will be performed 36 hours after the trigger medication(s) is administered. Cycles with a poor ovarian response, defined as <3 follicles and/or a peak estradiol level <600 pg/mL, will be canceled.
Patients will undergo culture day 5 embryo transfer; number of embryos transferred will be according to ASRM guidelines. If the patient exhibits symptoms of OHSS, she will discontinue luteal phase support and will not have an embryo transfer, and all good quality blastocyst mbryos will be cryopreserved. All patients eligible for embryo transfer will continue the luteal phase support protocol until the serum hCG pregnancy test 14 days post-retrieval. If the serum hCG is <5 mIU/mL, luteal phase support will be discontinued. If the serum hCG is ≥5 mIU/mL, Estrace will continue to be taken until 8 weeks gestation and Endometrin or intramuscular progesterone in oil will continue to be used until 10 weeks gestation. At this point, patient is released to the care of the obstetrician. The patient or the obstetrician will be contacted for pregnancy outcome data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AMH<1.5, 300IU Gonal-F + 150 IU Menopur | Experimental | Drug: 300IU Gonal-F, Drug: 150IU Menopurdosage at 300IU Gonal-F + 150IU Menopur |
| AMH 1.6-2.5, 225IU Gonal-F+75IU Menopur | Experimental | Drug: 225IU Gonal-F, Drug: 75IU Menopurdosage of 225IU Gonal-F + 75IU Menopur |
| AMH 2.6-6.9, 150IU Gonal-F+75IU Menopur | Experimental | Drug: 75IU Menopur, Drug: 150IU Gonal-Fstart dosage of 150IU Gonal-F and 75IU Menopur |
| AMH >=7.0, 75IU Gonal-F+75U Menopur | Experimental | Drug: 75IU Menopur, Drug: 75IU Gonal-Fstart dosage of 75IU Gonal-F and 75U Menopur |
Who may qualify
- Ages
- 25 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- first cycle of IVF with transfer of fresh embryo
Key exclusion criteria (1 listed)
- use of non-autologous oocytes; prior diagnosis of premature ovarian failure or diminished ovarian reserve; BMI>= 40; cryopreservation cycles; smokers; use of PGS/PGD; use of surgically retrieved sperm or patients with severe male factor; and oocyte- or embryo-banking cycles
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 |
|---|---|---|
| 300IU Gonal-FAlso: follitropin<1.5 AMH group | Drug | AMH<1.5, 300IU Gonal-F + 150 IU Menopur |
| 150IU MenopurAlso: menotropin<1.5 AMH group | Drug | AMH<1.5, 300IU Gonal-F + 150 IU Menopur |
| 225IU Gonal-F1.6-2.5 AMH group | Drug | AMH 1.6-2.5, 225IU Gonal-F+75IU Menopur |
| 75IU Menopur1.6-2.5 AMH group 2.6-6.9 AMH group >7.0 AMH group | Drug | AMH 1.6-2.5, 225IU Gonal-F+75IU Menopur, AMH 2.6-6.9, 150IU Gonal-F+75IU Menopur, AMH >=7.0, 75IU Gonal-F+75U Menopur |
| 150IU Gonal-F2.6-6.9 AMH group | Drug | AMH 2.6-6.9, 150IU Gonal-F+75IU Menopur |
| 75IU Gonal-F>7.0 AMH group | Drug | AMH >=7.0, 75IU Gonal-F+75U Menopur |
Primary outcome
clinical pregnancy rate
Time frame: two years
Clinical pregnancy rate is defined as the number of pregnancies with the presence of an intrauterine gestational sac seen on transvaginal ultrasound by six weeks gestation divided by the number of completed embryo transfers.
1 secondary outcome
Oocyte yield
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Background: PubMed 22119275Anderson RA, Nelson SM, Wallace WH. Measuring anti-Mullerian hormone for the assessment of ovarian reserve: when and for whom is it indicated? Maturitas. 2012 Jan;71(1):28-33. doi: 10.1016/j.maturitas.2011.11.008. Epub 2011 Nov 26.
- Background: PubMed 11821097de Vet A, Laven JS, de Jong FH, Themmen AP, Fauser BC. Antimullerian hormone serum levels: a putative marker for ovarian aging. Fertil Steril. 2002 Feb;77(2):357-62. doi: 10.1016/s0015-0282(01)02993-4.
- Background: PubMed 17194966Freour T, Mirallie S, Colombel A, Bach-Ngohou K, Masson D, Barriere P. Anti-mullerian hormone: clinical relevance in assisted reproductive therapy. Ann Endocrinol (Paris). 2006 Dec;67(6):567-74. doi: 10.1016/s0003-4266(06)73008-6.
- Background: PubMed 22170712Gleicher N, Kim A, Weghofer A, Barad DH. Toward a better understanding of functional ovarian reserve: AMH (AMHo) and FSH (FSHo) hormone ratios per retrieved oocyte. J Clin Endocrinol Metab. 2012 Mar;97(3):995-1004. doi: 10.1210/jc.2011-2403. Epub 2011 Dec 14.
- Background: PubMed 19046583Jayaprakasan K, Campbell B, Hopkisson J, Johnson I, Raine-Fenning N. A prospective, comparative analysis of anti-Mullerian hormone, inhibin-B, and three-dimensional ultrasound determinants of ovarian reserve in the prediction of poor response to controlled ovarian stimulation. Fertil Steril. 2010 Feb;93(3):855-64. doi: 10.1016/j.fertnstert.2008.10.042. Epub 2008 Nov 30.
- Background: PubMed 17923131Kwee J, Schats R, McDonnell J, Themmen A, de Jong F, Lambalk C. Evaluation of anti-Mullerian hormone as a test for the prediction of ovarian reserve. Fertil Steril. 2008 Sep;90(3):737-43. doi: 10.1016/j.fertnstert.2007.07.1293. Epub 2007 Oct 17.
- Background: PubMed 23531919Panchal S, Nagori C. Comparison of anti-mullerian hormone and antral follicle count for assessment of ovarian reserve. J Hum Reprod Sci. 2012 Sep;5(3):274-8. doi: 10.4103/0974-1208.106340.
- Background: PubMed 15730360Tremellen KP, Kolo M, Gilmore A, Lekamge DN. Anti-mullerian hormone as a marker of ovarian reserve. Aust N Z J Obstet Gynaecol. 2005 Feb;45(1):20-4. doi: 10.1111/j.1479-828X.2005.00332.x.
- Background: PubMed 12456604van Rooij IA, Broekmans FJ, te Velde ER, Fauser BC, Bancsi LF, de Jong FH, Themmen AP. Serum anti-Mullerian hormone levels: a novel measure of ovarian reserve. Hum Reprod. 2002 Dec;17(12):3065-71. doi: 10.1093/humrep/17.12.3065.
- Background: PubMed 21824441Biasoni V, Patriarca A, Dalmasso P, Bertagna A, Manieri C, Benedetto C, Revelli A. Ovarian sensitivity index is strongly related to circulating AMH and may be used to predict ovarian response to exogenous gonadotropins in IVF. Reprod Biol Endocrinol. 2011 Aug 9;9:112. doi: 10.1186/1477-7827-9-112.
- Background: PubMed 22384435Choi MH, Yoo JH, Kim HO, Cha SH, Park CW, Yang KM, Song IO, Koong MK, Kang IS. Serum anti-Mullerian hormone levels as a predictor of the ovarian response and IVF outcomes. Clin Exp Reprod Med. 2011 Sep;38(3):153-8. doi: 10.5653/cerm.2011.38.3.153. Epub 2011 Sep 30.
- Background: PubMed 17658520Elgindy EA, El-Haieg DO, El-Sebaey A. Anti-Mullerian hormone: correlation of early follicular, ovulatory and midluteal levels with ovarian response and cycle outcome in intracytoplasmic sperm injection patients. Fertil Steril. 2008 Jun;89(6):1670-6. doi: 10.1016/j.fertnstert.2007.05.040. Epub 2007 Jul 20.
- Individual participant dataSharing planned: Undecided
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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.
Linda Sung, MD principal investigator
Reproductive Specialists of New York
Questions about this trial
What is this clinical trial studying?
A study testing 300IU Gonal-F, 150IU Menopur and 225IU Gonal-F in people with Infertility, run by Reproductive Specialists of New York.
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: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
clinical pregnancy rate (time frame: two years). 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 NCT03098199, which also lists 27 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 12 Apr 2018.