Poor Response to Ovulation InductionNCT05298657
The Angiotensin-Melatonin Axis in Poor and Hyper Responders for IVF Treatment
An observational study of Poor Response to Ovulation Induction and PCOS, run by Fatima College of Health Sciences at 1 site in United Arab Emirates.
Trial summary
According the World Health Organization (WHO), infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. In-vitro-fertilization (IVF) is considered to be a successful tool to overcome infertility. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poor Response to Ovulation Induction, PCOS, Endometriosis
- How many people
- 200 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Sep 2022to 31 Aug 2024
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: From the ART Fertility Clinic, Abu Dhabi, UAE, our collaborator in the project, we are planning to enroll (following the selection criteria detailed below) for a duration of 18 months, IVF female patients aged between 18 and 45 years old and who volunteer to participate in the study. Participants in the study have to sign a participant Information sheet and consent form specific to the urine testing before their enrollment in the study. A questionnaire will be filled out with the different demographics and a summary of the IVF protocol details.
Who may be able to join
- depending on the ART Fertility Clinic patients, we are intending to include:
- Women diagnosed with infertility (when pregnancy is not achieved after 1 year of having regular sexual intercourse without birth control for those under 35 years of age or if pregnancy is not achieved after 6 months of trying to conceive naturally for those older than 35 years of age). Further on, women with proven tubal factor infertility or couples with infertility as a result of a male factor, without the previously mentioned time of not achieving a pregnancy.
- Women undergoing or in the way to undergo IVF and classified as poor responders according to the four groups of the POSEIDON criteria (Conforti et al., 2019), including patients with a previous oral contraceptive intake.
- Women diagnosed with PCOS based on the Rotterdam criteria (Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group, 2004.
- Women diagnosed with endometriosis confirmed by Laparoscopy or visible endometrioma without being diagnosed by laparoscopy (If possible to be enrolled in the research).
- Women planned to undergo IVF treatment and categorized as expected normal responders) (Ozkan, 2019).
- Patients under thyroid medication.
Who cannot join
- Presence or history of endocrine abnormalities (at the exception of patients who are under thyroid medication).
- Abnormal outcome of blood biochemistry or hematology.
- Obese patients with BMI > 40.
- Couples for whom the male partner has to undergo surgical sperm retrieval.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
ART Fertility Clinic
Abu Dhabi, Abu Dhabi Emirate
Barbara Lawrenz, PhD, +971526500757, barbara.lawrenz@artfertilityclinics.com
About this study
According the World Health Organization (WHO), infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. In-vitro-fertilization (IVF) is considered to be a successful tool to overcome infertility. However, the current methods used to assess the ovarian reserve and to develop an optimal individualized controlled ovarian hyperstimulation (COH) protocol have shown some limitations. Growing evidence indicates that altered renal renin-angiotensin system (RAS) and/or melatonin are linked to infertility. Aims and Objectives: The current 2 years duration study aims first to investigate the demographic and clinical profiles of patients undergoing IVF in the UAE. In the second phase of the study, we hypothesis that an altered angiotensin-melatonin axis may be considered as an unfavorable prognosis factor in poor and hyper responders undergoing IVF treatment. This hypothesis will be assessed using an observational, longitudinal, prospective clinical study to determine whether the urinary angiotensinogen and/or melatonin deficiency might be present in poor and hyper responders undergoing IVF treatment. Thus, negatively impacting the clinical pregnancy rate. Methodology: various patient's data will be collected using a questionnaire and the levels of angiotensinogen and melatonin in patient's urine will be measured using ELISA test prior to, during and after the IVF treatment. To determine whether the angiotensinogen-melatonin axis disruption affects the IVF treatment outcome, we will analyze the following parameters: the AMH, Antral Follicular Count (AFC), day 2-4 FSH levels, the stimulation cycle in regards to number of stimulation days and amount of gonadotropins used for stimulation, number of oocytes retrieved and number of mature oocytes, quality and embryo's ploidy, number of available euploid embryos and the clinical pregnancy rate after frozen embryo transfer.
Read the detailed description
Infertility affects approximately 1 in every 4 couples and the WHO (World Health Organization) has defined infertility as a "disease" (World Health Organization (WHO). International Classification of Diseases, 11th Revision (ICD-11) Geneva: WHO 2018.). Rates of infertility are expected to increase in the future as many couples tend to postpone family planning due to various reasons (Mills et al., 2011). Assisted Reproductive Techniques (ART), with In-vitro-fertilization (IVF) being a part of the treatment options, are a successful tool to overcome infertility (Franasiak \& Scott, 2014). However, more research to thwart the global burden of infertility is required. This is possible if the underlying causes of infertility can be identified, and personalized therapy implemented (Sun et al., 2019).
Poor and hyper responders are a diverse group of IVF patients, with specific needs. Their management can help in increasing the clinical pregnancy rates. Identifying and understanding how the endocrine variants are linked to the success of IVF responsiveness may lead to a better treatment strategy aimed at achieving successful live births.
Growing evidence indicates that altered renal renin-angiotensin system (RAS) and melatonin are linked to infertility, PCOS and endometriosis.
According to the literature, hyperandrogenemia in an experimental rat model of PCOS has been associated with an upregulation of the intrarenal RAS (Torres Fernandez et al. 2019). When compared to the eutopic endometrium in the proliferative phase, patients with endometriotic cysts had a significant increase in the expression of angiotensin type AT1 and AT2 receptors. This suggests that RAS may be involved in the pathophysiology of endometriosis (Nakao et al. 2017; Nakajima et al. 2018). In addition, alterations in the expression of Angiotensin-converting enzyme, ACE-1, ACE-2, and ACE-3 might be one of the most important mechanisms underlying both female and male infertility (Chen, Bi, Su, Chappell, \& Rose, 2016; Pan, Zhan, Le, Zheng, \& Jin, 2013).
On the other hand, the levels of melatonin, a powerful antioxidant and an effective free radical scavenger that protects ovarian follicles during follicular maturation are increasing in preovulatory follicular fluid and seem to have an important role in ovulation (Tamura et al., 2012). Similarly, melatonin requirements appear to increase during pregnancy (Voiculescu, Zygouropoulos, Zahiu, \& Zagrean, 2014). Melatonin levels are found to be lower in patients with PCOS (Mojaverrostami et al. 2019). And several studies suggest a potential link between melatonin and endometriosis (Mosher et al. 2019; Anderson 2019), leading to the use of melatonin as an adjuvant in the treatment of endometriosis (Mosher et al. 2019; Yesildaglar et al. 2016).
Clinical hypothesis:
This observational, longitudinal, prospective clinical study will investigate the IVF population demographic and clinical profile in the UAE. It will also test the hypothesis whether an altered angiotensin-melatonin axis may be considered an unfavorable prognosis factor in poor responders with or without endometriosis and hyper (PCOS) responders undergoing IVF treatment. Thus, negatively impacting the clinical pregnancy rate.
- Medical subject headings
- Endometriosis, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Poor IVF Treatment Responders | Not described | |
| Hyper IVF Treatment Responders | Not described | |
| Normal responders/ Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences on urine levels of angiotensinogen-melatonin-creatinine ratio between two groups: one with AMH < 1.1 ng/ml against other with AMH > 6.25 ng/ml.
Urinary excretion of angiotensinogen will be analyzed by sandwich-ELISA assay. Urinary melatonin excreted overnight will be determined through the 6-sulfatoxymelatonin molecule. This is a metabolite released in the urine that correlates directly with the melatonin produced, being a noninvasive method of dosing the said molecule. The urinary dosage of 6-sulfatoximelatonin will be performed by the ELISA technique according to the manufacturer's recommendations (IBL International Germany). All molecules will be quantitated using ELISA according to supplier's specifications.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Poor Response to Ovulation InductionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Fatima College of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- ART Fertility Clinics LLC
- Responsible party
- Principal investigator, Rym Ghimouz, Fatima College of Health Sciences
- Investigators
- Rym Ghimouz, PhD, Principal investigator, Fatima College of Health SciencesBarbara Lawrenz, PhD, Principal investigator, ART Fertility ClinicsLuciana Campos, PhD, Principal investigator, Universidade Anhembi Morumbi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298657
- Sponsor's protocol ID
- FCEC-1-21-22-GRD-1-SF
- Other IDs
- REFA073
- Status last verified
- Jul 2022
- First submitted
- 17 Mar 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson G. Endometriosis Pathoetiology and Pathophysiology: Roles of Vitamin A, Estrogen, Immunity, Adipocytes, Gut Microbiome and Melatonergic Pathway on Mitochondria Regulation. Biomol Concepts. 2019 Jul 19;10(1):133-149. doi: 10.1515/bmc-2019-0017.
PubMed 31339848Barbakadze L, Kristesashvili J, Khonelidze N, Tsagareishvili G. The correlations of anti-mullerian hormone, follicle-stimulating hormone and antral follicle count in different age groups of infertile women. Int J Fertil Steril. 2015 Jan-Mar;8(4):393-8. doi: 10.22074/ijfs.2015.4179. Epub 2015 Feb 7.
PubMed 25780521Chen K, Bi J, Su Y, Chappell MC, Rose JC. Sex-Specific Changes in Renal Angiotensin-Converting Enzyme and Angiotensin-Converting Enzyme 2 Gene Expression and Enzyme Activity at Birth and Over the First Year of Life. Reprod Sci. 2016 Feb;23(2):200-10. doi: 10.1177/1933719115597760. Epub 2015 Aug 4.
PubMed 26243544Conforti A, Esteves SC, Cimadomo D, Vaiarelli A, Di Rella F, Ubaldi FM, Zullo F, De Placido G, Alviggi C. Management of Women With an Unexpected Low Ovarian Response to Gonadotropin. Front Endocrinol (Lausanne). 2019 Jun 27;10:387. doi: 10.3389/fendo.2019.00387. eCollection 2019.
PubMed 31316461Franasiak JM, Scott RT Jr. Embryonic aneuploidy: overcoming molecular genetics challenges improves outcomes and changes practice patterns. Trends Mol Med. 2014 Sep;20(9):499-508. doi: 10.1016/j.molmed.2014.06.006. Epub 2014 Aug 8.
PubMed 25113799Irani M, Robles A, Gunnala V, Reichman D, Rosenwaks Z. Optimal parameters for determining the LH surge in natural cycle frozen-thawed embryo transfers. J Ovarian Res. 2017 Oct 16;10(1):70. doi: 10.1186/s13048-017-0367-7.
PubMed 29037231Kuwayama M. Highly efficient vitrification for cryopreservation of human oocytes and embryos: the Cryotop method. Theriogenology. 2007 Jan 1;67(1):73-80. doi: 10.1016/j.theriogenology.2006.09.014. Epub 2006 Oct 20.
PubMed 17055564La Marca A, Sunkara SK. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum Reprod Update. 2014 Jan-Feb;20(1):124-40. doi: 10.1093/humupd/dmt037. Epub 2013 Sep 29.
PubMed 24077980Levi-Setti PE, Zerbetto I, Baggiani A, Zannoni E, Sacchi L, Smeraldi A, Morenghi E, De Cesare R, Drovanti A, Santi D. An Observational Retrospective Cohort Trial on 4,828 IVF Cycles Evaluating Different Low Prognosis Patients Following the POSEIDON Criteria. Front Endocrinol (Lausanne). 2019 May 8;10:282. doi: 10.3389/fendo.2019.00282. eCollection 2019.
PubMed 31139146Mills M, Rindfuss RR, McDonald P, te Velde E; ESHRE Reproduction and Society Task Force. Why do people postpone parenthood? Reasons and social policy incentives. Hum Reprod Update. 2011 Nov-Dec;17(6):848-60. doi: 10.1093/humupd/dmr026. Epub 2011 Jun 7.
PubMed 21652599Mojaverrostami S, Asghari N, Khamisabadi M, Heidari Khoei H. The role of melatonin in polycystic ovary syndrome: A review. Int J Reprod Biomed. 2019 Dec 30;17(12):865-882. doi: 10.18502/ijrm.v17i12.5789. eCollection 2019 Dec.
PubMed 31970309Mosher AA, Tsoulis MW, Lim J, Tan C, Agarwal SK, Leyland NA, Foster WG. Melatonin activity and receptor expression in endometrial tissue and endometriosis. Hum Reprod. 2019 Jul 8;34(7):1215-1224. doi: 10.1093/humrep/dez082.
PubMed 31211323Nakajima T, Chishima F, Nakao T, Hayashi C, Kasuga A, Shinya K, Nakayama T, Azuma H, Ichikawa G, Komatsu A, Yamamoto T, Kawana K. The Expression of MAS1, an Angiotensin (1-7) Receptor, in the Eutopic Proliferative Endometria of Endometriosis Patients. Gynecol Obstet Invest. 2018;83(6):600-607. doi: 10.1159/000490561. Epub 2018 Jul 6.
PubMed 29982252Nakao T, Chishima F, Sugitani M, Tsujimura R, Hayashi C, Yamamoto T. Expression of Angiotensin II Types 1 and 2 Receptors in Endometriotic Lesions. Gynecol Obstet Invest. 2017;82(3):294-302. doi: 10.1159/000447591. Epub 2016 Jul 7.
PubMed 27384958Pan PP, Zhan QT, Le F, Zheng YM, Jin F. Angiotensin-converting enzymes play a dominant role in fertility. Int J Mol Sci. 2013 Oct 21;14(10):21071-86. doi: 10.3390/ijms141021071.
PubMed 24152441
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Angiotensin-Melatonin Axis in Poor and Hyper Responders for IVF Treatment
- ClinicalTrials.gov ID
- NCT05298657
- Acronym / sponsor ID
- FCEC-1-21-22-GRD-1-SF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fatima College of Health SciencesUniversity, hospital or other
- Collaborators
- ART Fertility Clinics LLC
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 28 Mar 2022 (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.
According the World Health Organization (WHO), infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. In-vitro-fertilization (IVF) is considered to be a successful tool to overcome infertility. However, the current methods used to assess the ovarian reserve and to develop an optimal individualized controlled ovarian hyperstimulation (COH) protocol have shown some limitations. Growing evidence indicates that altered renal renin-angiotensin system (RAS) and/or melatonin are linked to infertility. Aims and Objectives: The current 2 years duration study aims first to investigate the demographic and clinical profiles of patients undergoing IVF in the UAE. In the second phase of the study, we hypothesis that an altered angiotensin-melatonin axis may be considered as an unfavorable prognosis factor in poor and hyper responders undergoing IVF treatment. This hypothesis will be assessed using an observational, longitudinal, prospective clinical study to determine whether the urinary angiotensinogen and/or melatonin deficiency might be present in poor and hyper responders undergoing IVF treatment. Thus, negatively impacting the clinical pregnancy rate. Methodology: various patient's data will be collected using a questionnaire and the levels of angiotensinogen and melatonin in patient's urine will be measured using ELISA test prior to, during and after the IVF treatment. To determine whether the angiotensinogen-melatonin axis disruption affects the IVF treatment outcome, we will analyze the following parameters: the AMH, Antral Follicular Count (AFC), day 2-4 FSH levels, the stimulation cycle in regards to number of stimulation days and amount of gonadotropins used for stimulation, number of oocytes retrieved and number of mature oocytes, quality and embryo's ploidy, number of available euploid embryos and the clinical pregnancy rate after frozen embryo transfer.
Detailed description
Infertility affects approximately 1 in every 4 couples and the WHO (World Health Organization) has defined infertility as a "disease" (World Health Organization (WHO). International Classification of Diseases, 11th Revision (ICD-11) Geneva: WHO 2018.). Rates of infertility are expected to increase in the future as many couples tend to postpone family planning due to various reasons (Mills et al., 2011). Assisted Reproductive Techniques (ART), with In-vitro-fertilization (IVF) being a part of the treatment options, are a successful tool to overcome infertility (Franasiak \& Scott, 2014). However, more research to thwart the global burden of infertility is required. This is possible if the underlying causes of infertility can be identified, and personalized therapy implemented (Sun et al., 2019).
Poor and hyper responders are a diverse group of IVF patients, with specific needs. Their management can help in increasing the clinical pregnancy rates. Identifying and understanding how the endocrine variants are linked to the success of IVF responsiveness may lead to a better treatment strategy aimed at achieving successful live births.
Growing evidence indicates that altered renal renin-angiotensin system (RAS) and melatonin are linked to infertility, PCOS and endometriosis.
According to the literature, hyperandrogenemia in an experimental rat model of PCOS has been associated with an upregulation of the intrarenal RAS (Torres Fernandez et al. 2019). When compared to the eutopic endometrium in the proliferative phase, patients with endometriotic cysts had a significant increase in the expression of angiotensin type AT1 and AT2 receptors. This suggests that RAS may be involved in the pathophysiology of endometriosis (Nakao et al. 2017; Nakajima et al. 2018). In addition, alterations in the expression of Angiotensin-converting enzyme, ACE-1, ACE-2, and ACE-3 might be one of the most important mechanisms underlying both female and male infertility (Chen, Bi, Su, Chappell, \& Rose, 2016; Pan, Zhan, Le, Zheng, \& Jin, 2013).
On the other hand, the levels of melatonin, a powerful antioxidant and an effective free radical scavenger that protects ovarian follicles during follicular maturation are increasing in preovulatory follicular fluid and seem to have an important role in ovulation (Tamura et al., 2012). Similarly, melatonin requirements appear to increase during pregnancy (Voiculescu, Zygouropoulos, Zahiu, \& Zagrean, 2014). Melatonin levels are found to be lower in patients with PCOS (Mojaverrostami et al. 2019). And several studies suggest a potential link between melatonin and endometriosis (Mosher et al. 2019; Anderson 2019), leading to the use of melatonin as an adjuvant in the treatment of endometriosis (Mosher et al. 2019; Yesildaglar et al. 2016).
Clinical hypothesis:
This observational, longitudinal, prospective clinical study will investigate the IVF population demographic and clinical profile in the UAE. It will also test the hypothesis whether an altered angiotensin-melatonin axis may be considered an unfavorable prognosis factor in poor responders with or without endometriosis and hyper (PCOS) responders undergoing IVF treatment. Thus, negatively impacting the clinical pregnancy rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Poor IVF Treatment Responders | – | – |
| Hyper IVF Treatment Responders | – | – |
| Normal responders/ Control group | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- From the ART Fertility Clinic, Abu Dhabi, UAE, our collaborator in the project, we are planning to enroll (following the selection criteria detailed below) for a duration of 18 months, IVF female patients aged between 18 and 45 years old and who volunteer to participate in the study. Participants in the study have to sign a participant Information sheet and consent form specific to the urine testing before their enrollment in the study. A questionnaire will be filled out with the different demographics and a summary of the IVF protocol details.
Key inclusion criteria (7 listed)
- Women diagnosed with infertility (when pregnancy is not achieved after 1 year of having regular sexual intercourse without birth control for those under 35 years of age or if pregnancy is not achieved after 6 months of trying to conceive naturally for those older than 35 years of age). Further on, women with proven tubal factor infertility or couples with infertility as a result of a male factor, without the previously mentioned time of not achieving a pregnancy.
- Women undergoing or in the way to undergo IVF and classified as poor responders according to the four groups of the POSEIDON criteria (Conforti et al., 2019), including patients with a previous oral contraceptive intake.
- Women diagnosed with PCOS based on the Rotterdam criteria (Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group, 2004.
- Women diagnosed with endometriosis confirmed by Laparoscopy or visible endometrioma without being diagnosed by laparoscopy (If possible to be enrolled in the research).
- Women planned to undergo IVF treatment and categorized as expected normal responders) (Ozkan, 2019).
Key exclusion criteria (4 listed)
- Presence or history of endocrine abnormalities (at the exception of patients who are under thyroid medication).
- Abnormal outcome of blood biochemistry or hematology.
- Obese patients with BMI > 40.
- Couples for whom the male partner has to undergo surgical sperm retrieval.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences on urine levels of angiotensinogen-melatonin-creatinine ratio between two groups: one with AMH < 1.1 ng/ml against other with AMH > 6.25 ng/ml.
Time frame: 18 months
Urinary excretion of angiotensinogen will be analyzed by sandwich-ELISA assay. Urinary melatonin excreted overnight will be determined through the 6-sulfatoxymelatonin molecule. This is a metabolite released in the urine that correlates directly with the melatonin produced, being a noninvasive method of dosing the said molecule. The urinary dosage of 6-sulfatoximelatonin will be performed by the ELISA technique according to the manufacturer's recommendations (IBL International Germany). All molecules will be quantitated using ELISA according to supplier's specifications.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Background: PubMed 31339848Anderson G. Endometriosis Pathoetiology and Pathophysiology: Roles of Vitamin A, Estrogen, Immunity, Adipocytes, Gut Microbiome and Melatonergic Pathway on Mitochondria Regulation. Biomol Concepts. 2019 Jul 19;10(1):133-149. doi: 10.1515/bmc-2019-0017.
- Background: PubMed 25780521Barbakadze L, Kristesashvili J, Khonelidze N, Tsagareishvili G. The correlations of anti-mullerian hormone, follicle-stimulating hormone and antral follicle count in different age groups of infertile women. Int J Fertil Steril. 2015 Jan-Mar;8(4):393-8. doi: 10.22074/ijfs.2015.4179. Epub 2015 Feb 7.
- Background: PubMed 26243544Chen K, Bi J, Su Y, Chappell MC, Rose JC. Sex-Specific Changes in Renal Angiotensin-Converting Enzyme and Angiotensin-Converting Enzyme 2 Gene Expression and Enzyme Activity at Birth and Over the First Year of Life. Reprod Sci. 2016 Feb;23(2):200-10. doi: 10.1177/1933719115597760. Epub 2015 Aug 4.
- Background: PubMed 31316461Conforti A, Esteves SC, Cimadomo D, Vaiarelli A, Di Rella F, Ubaldi FM, Zullo F, De Placido G, Alviggi C. Management of Women With an Unexpected Low Ovarian Response to Gonadotropin. Front Endocrinol (Lausanne). 2019 Jun 27;10:387. doi: 10.3389/fendo.2019.00387. eCollection 2019.
- Background: PubMed 25113799Franasiak JM, Scott RT Jr. Embryonic aneuploidy: overcoming molecular genetics challenges improves outcomes and changes practice patterns. Trends Mol Med. 2014 Sep;20(9):499-508. doi: 10.1016/j.molmed.2014.06.006. Epub 2014 Aug 8.
- Background: PubMed 29037231Irani M, Robles A, Gunnala V, Reichman D, Rosenwaks Z. Optimal parameters for determining the LH surge in natural cycle frozen-thawed embryo transfers. J Ovarian Res. 2017 Oct 16;10(1):70. doi: 10.1186/s13048-017-0367-7.
- Background: PubMed 17055564Kuwayama M. Highly efficient vitrification for cryopreservation of human oocytes and embryos: the Cryotop method. Theriogenology. 2007 Jan 1;67(1):73-80. doi: 10.1016/j.theriogenology.2006.09.014. Epub 2006 Oct 20.
- Background: PubMed 24077980La Marca A, Sunkara SK. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum Reprod Update. 2014 Jan-Feb;20(1):124-40. doi: 10.1093/humupd/dmt037. Epub 2013 Sep 29.
- Background: PubMed 31139146Levi-Setti PE, Zerbetto I, Baggiani A, Zannoni E, Sacchi L, Smeraldi A, Morenghi E, De Cesare R, Drovanti A, Santi D. An Observational Retrospective Cohort Trial on 4,828 IVF Cycles Evaluating Different Low Prognosis Patients Following the POSEIDON Criteria. Front Endocrinol (Lausanne). 2019 May 8;10:282. doi: 10.3389/fendo.2019.00282. eCollection 2019.
- Background: PubMed 21652599Mills M, Rindfuss RR, McDonald P, te Velde E; ESHRE Reproduction and Society Task Force. Why do people postpone parenthood? Reasons and social policy incentives. Hum Reprod Update. 2011 Nov-Dec;17(6):848-60. doi: 10.1093/humupd/dmr026. Epub 2011 Jun 7.
- Background: PubMed 31970309Mojaverrostami S, Asghari N, Khamisabadi M, Heidari Khoei H. The role of melatonin in polycystic ovary syndrome: A review. Int J Reprod Biomed. 2019 Dec 30;17(12):865-882. doi: 10.18502/ijrm.v17i12.5789. eCollection 2019 Dec.
- Background: PubMed 31211323Mosher AA, Tsoulis MW, Lim J, Tan C, Agarwal SK, Leyland NA, Foster WG. Melatonin activity and receptor expression in endometrial tissue and endometriosis. Hum Reprod. 2019 Jul 8;34(7):1215-1224. doi: 10.1093/humrep/dez082.
- Individual participant dataSharing planned: No
Related trials for Poor Response to Ovulation Induction
RecruitingPhase 2/3
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
Poor Response to Ovulation Induction, Infertility, Female
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.
Rym Ghimouz, PhD principal investigator
Fatima College of Health Sciences
Barbara Lawrenz, PhD principal investigator
ART Fertility Clinics
Luciana Campos, PhD principal investigator
Universidade Anhembi Morumbi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Response to Ovulation Induction and PCOS, run by Fatima College of Health Sciences at 1 site in United Arab Emirates.
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 7 inclusion and 4 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 12 Jul 2022. 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 Arab Emirates. 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.
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?
Contact Rym Ghimouz, PhD (+971551156892, rym.ghimouz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences on urine levels of angiotensinogen-melatonin-creatinine ratio between two groups: one with AMH < 1.1 ng/ml against other with AMH > 6.25 ng/ml. (time frame: 18 months). 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 NCT05298657, which also lists 26 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 Jul 2022.