Infertility, FemaleNCT05969574
Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
An observational study of Infertility, Female and Miscarriage, run by ART Fertility Clinics LLC at 3 sites in United Arab Emirates.
Trial summary
This study aims to explore the potential correlation between decreased ovarian reserve and previous history of early miscarriage. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility, Female, Miscarriage, Miscarriage, Recurrent
- What is being tested?
- Transvaginal ultrasound and Blood test AMH
- How many people
- 2,059 participants
- Where
- 3 sitesUnited Arab Emirates
- Study dates
- 9 Sep 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Child, Adult, Older adult
Study population: All participants who visit ART Fertility clinics in Abu Dhabi, Al Ain and Dubai for first consultation
Who may be able to join
- 1. All participants with at least 1 previous pregnancy, who are assessed in one of our clinics (ART Fertility Clinics Abu Dhabi, Al Ain, Dubai)
Who cannot join
- Severe male factor (azoospermia, cryptozoospermia, severe oligoasthenoteratozoospermia (OAT))
- Severe Endometriosis and adenomyosis based on positive anamnesis or ultrasound performed in our center during the first consultation
- Uterine abnormalities (e.g. fibroids, different degrees of uterine septum), diagnosed by ultrasound
- History of ovarian surgery, chemotherapy, or radiation therapy
- Known genetic disorder or chromosomal abnormality
- BMI >40Kg/m2
- Currently using hormonal contraception or hormone replacement therapy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates3 sites, 3 recruiting
- Recruiting
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, 60202
Laura Melado, PhD, +971 800 337845489, laura.melado@artfertilityclinics.com
Jonalyn Edades, RN, +971 800 337845489, jonalyn.edades@artfertilityclinics.com
- Recruiting
ART Fertility Clinics Al Ain
Al Ain City
Anastasia Salame, MD, +971 800 337845489, jonalyn.edades@artfertilityclinics.com
- Recruiting
ART Fertility Clinics Dubai
Dubai
Carol Coughlan, PhD, +971 800 337845489, jonalyn.edades@artfertilityclinics.com
About this study
Official title: Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages? A Prospective Observational Study
This study aims to explore the potential correlation between decreased ovarian reserve and previous history of early miscarriage.
Read the detailed description
By investigating the prevalence of low ovarian reserve (LOR) in populations with specific reproductive histories (such as recurrent pregnancy loss, G0, and ectopic pregnancy), as well as the aneuploidy rates of embryos produced with Preimplantation Genetic Testing for Aneuploidies (PGT-A), Investigators can better understand how LOR impacts fertility outcomes in these populations. This information can be used to inform clinical decision-making, such as whether participants with LOR should consider alternative or whether they would benefit from additional interventions to improve ovarian function.
Ultimately, by improving our understanding of how LOR impacts fertility outcomes in specific populations, Investigators can help to improve the overall success rates of infertility treatment, reduce anxiety, and distress, and help participants achieve goals of becoming parents.
- Conditions
- Infertility, Female, Miscarriage, Miscarriage, Recurrent, IVF
- Being tested
- Transvaginal ultrasound, Blood test AMH
- Keywords
- miscarriage, infertility, IVF
- Medical subject headings
- Infertility, Female, Abortion, Spontaneous, Abortion, Habitual, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasoundDiagnostic test
Transvaginal ultrasound for antral follicle count (AFC) performed on the day of first consultation
Blood test AMHDiagnostic test
Measurement of AMH performed on the day of first consultation
| Study group | Role | What they receive |
|---|---|---|
| AMH <1.3, at least 1 pregnancy or at least 1 miscarriage | Participants will not undergo any additional intervention compared to normal clinical assessment and routine testing of the ovarian reserve, which includes AMH and AFC. Investigators will follow standard stimulation protocols and medications. Receives: Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Blood test AMH | |
| AMH <1.3, at least 1 pregnancy and no miscarriage | Participants will not undergo any additional intervention compared to normal clinical assessment and routine testing of the ovarian reserve, which includes AMH and AFC. Investigators will follow standard stimulation protocols and medications. Receives: Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Blood test AMH | |
| AMH ≥ 1.3, at least 1 pregnancy or at least 1 miscarriage | Participants will not undergo any additional intervention compared to normal clinical assessment and routine testing of the ovarian reserve, which includes AMH and AFC. Investigators will follow standard stimulation protocols and medications.ons. Receives: Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Blood test AMH | |
| AMH ≥1.3, at least 1 pregnancy and no miscarriage | Participants will not undergo any additional intervention compared to normal clinical assessment and routine testing of the ovarian reserve, which includes AMH and AFC. Investigators will follow standard stimulation protocols and medications. Receives: Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Blood test AMH |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH
Anti-Müllerian Hormone Test
Measured: 1 day
AFC
Antral follicle count
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start9 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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
- 2,059 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Melado, ART Fertility Clinics LLC
- Investigators
- Laura Melado, PhD, Principal investigator, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969574
- Sponsor's protocol ID
- 2305-ABU-007-LM
- Status last verified
- Jan 2026
- First submitted
- 24 Jul 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
ESHRE working group on Ectopic Pregnancy; Kirk E, Ankum P, Jakab A, Le Clef N, Ludwin A, Small R, Tellum T, Toyli M, Van den Bosch T, Jurkovic D. Terminology for describing normally sited and ectopic pregnancies on ultrasound: ESHRE recommendations for good practice. Hum Reprod Open. 2020 Dec 16;2020(4):hoaa055. doi: 10.1093/hropen/hoaa055. eCollection 2020.
PubMed 33354626Tan J, Luo L, Jiang J, Yan N, Wang Q. Decreased Ovarian Reserves With an Increasing Number of Previous Early Miscarriages: A Retrospective Analysis. Front Endocrinol (Lausanne). 2022 Jun 10;13:859332. doi: 10.3389/fendo.2022.859332. eCollection 2022.
PubMed 35757430Bliddal S, Feldt-Rasmussen U, Forman JL, Hilsted LM, Larsen EC, Christiansen OB, Nielsen CH, Kolte AM, Nielsen HS. Anti-Mullerian hormone and live birth in unexplained recurrent pregnancy loss. Reprod Biomed Online. 2023 Jun;46(6):995-1003. doi: 10.1016/j.rbmo.2023.01.023. Epub 2023 Feb 3.
PubMed 37055255Stirrat GM. Recurrent miscarriage. II: Clinical associations, causes, and management. Lancet. 1990 Sep 22;336(8717):728-33. doi: 10.1016/0140-6736(90)92215-4.
PubMed 1975901Wang X, Chen C, Wang L, Chen D, Guang W, French J. Conception, early pregnancy loss, and time to clinical pregnancy: a population-based prospective study. Fertil Steril. 2003 Mar;79(3):577-84. doi: 10.1016/s0015-0282(02)04694-0.
PubMed 12620443Coomarasamy A, Dhillon-Smith RK, Papadopoulou A, Al-Memar M, Brewin J, Abrahams VM, Maheshwari A, Christiansen OB, Stephenson MD, Goddijn M, Oladapo OT, Wijeyaratne CN, Bick D, Shehata H, Small R, Bennett PR, Regan L, Rai R, Bourne T, Kaur R, Pickering O, Brosens JJ, Devall AJ, Gallos ID, Quenby S. Recurrent miscarriage: evidence to accelerate action. Lancet. 2021 May 1;397(10285):1675-1682. doi: 10.1016/S0140-6736(21)00681-4. Epub 2021 Apr 27.
PubMed 33915096Bunnewell SJ, Honess ER, Karia AM, Keay SD, Al Wattar BH, Quenby S. Diminished ovarian reserve in recurrent pregnancy loss: a systematic review and meta-analysis. Fertil Steril. 2020 Apr;113(4):818-827.e3. doi: 10.1016/j.fertnstert.2019.11.014. Epub 2020 Mar 4.
PubMed 32145928Seifer DB. Connecting the dots between oocyte quantity and quality in diminished ovarian reserve. Fertil Steril. 2021 Apr;115(4):890. doi: 10.1016/j.fertnstert.2021.01.020. Epub 2021 Mar 6. No abstract available.
PubMed 33750616Tarasconi B, Tadros T, Ayoubi JM, Belloc S, de Ziegler D, Fanchin R. Serum antimullerian hormone levels are independently related to miscarriage rates after in vitro fertilization-embryo transfer. Fertil Steril. 2017 Sep;108(3):518-524. doi: 10.1016/j.fertnstert.2017.07.001.
PubMed 28865551Lyttle Schumacher BM, Jukic AMZ, Steiner AZ. Antimullerian hormone as a risk factor for miscarriage in naturally conceived pregnancies. Fertil Steril. 2018 Jun;109(6):1065-1071.e1. doi: 10.1016/j.fertnstert.2018.01.039. Epub 2018 Jun 2.
PubMed 29871793Atasever M, Soyman Z, Demirel E, Gencdal S, Kelekci S. Diminished ovarian reserve: is it a neglected cause in the assessment of recurrent miscarriage? A cohort study. Fertil Steril. 2016 May;105(5):1236-1240. doi: 10.1016/j.fertnstert.2016.01.001. Epub 2016 Jan 21.
PubMed 26806685Leclercq E, de Saint Martin L, Bohec C, Le Martelot MT, Roche S, Alavi Z, Mottier D, Pasquier E. Blood anti-Mullerian hormone is a possible determinant of recurrent early miscarriage, yet not conclusive in predicting a further miscarriage. Reprod Biomed Online. 2019 Aug;39(2):304-311. doi: 10.1016/j.rbmo.2019.04.004. Epub 2019 Apr 12.
PubMed 31186176Jaswa EG, McCulloch CE, Simbulan R, Cedars MI, Rosen MP. Diminished ovarian reserve is associated with reduced euploid rates via preimplantation genetic testing for aneuploidy independently from age: evidence for concomitant reduction in oocyte quality with quantity. Fertil Steril. 2021 Apr;115(4):966-973. doi: 10.1016/j.fertnstert.2020.10.051. Epub 2021 Feb 12.
PubMed 33583594
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages? A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05969574
- Acronym / sponsor ID
- 2305-ABU-007-LM
- Conditions
- Infertility, Female, Miscarriage, Miscarriage, Recurrent, IVF
- Keywords
- miscarriage, infertility, IVF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,059 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 2023 (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 study aims to explore the potential correlation between decreased ovarian reserve and previous history of early miscarriage.
Detailed description
By investigating the prevalence of low ovarian reserve (LOR) in populations with specific reproductive histories (such as recurrent pregnancy loss, G0, and ectopic pregnancy), as well as the aneuploidy rates of embryos produced with Preimplantation Genetic Testing for Aneuploidies (PGT-A), Investigators can better understand how LOR impacts fertility outcomes in these populations. This information can be used to inform clinical decision-making, such as whether participants with LOR should consider alternative or whether they would benefit from additional interventions to improve ovarian function.
Ultimately, by improving our understanding of how LOR impacts fertility outcomes in specific populations, Investigators can help to improve the overall success rates of infertility treatment, reduce anxiety, and distress, and help participants achieve goals of becoming parents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AMH <1.3, at least 1 pregnancy or at least 1 miscarriage | – | Diagnostic Test: Transvaginal ultrasound, Diagnostic Test: Blood test AMHParticipants will not undergo any additional intervention compared to normal clinical assessment and routine testing of the ovarian reserve, which includes AMH and AFC. Investigators will follow standard stimulation protocols and medications. |
| AMH <1.3, at least 1 pregnancy and no miscarriage | – | Diagnostic Test: Transvaginal ultrasound, Diagnostic Test: Blood test AMHParticipants will not undergo any additional intervention compared to normal clinical assessment and routine testing of the ovarian reserve, which includes AMH and AFC. Investigators will follow standard stimulation protocols and medications. |
| AMH ≥ 1.3, at least 1 pregnancy or at least 1 miscarriage | – | Diagnostic Test: Transvaginal ultrasound, Diagnostic Test: Blood test AMHParticipants will not undergo any additional intervention compared to normal clinical assessment and routine testing of the ovarian reserve, which includes AMH and AFC. Investigators will follow standard stimulation protocols and medications.ons. |
| AMH ≥1.3, at least 1 pregnancy and no miscarriage | – | Diagnostic Test: Transvaginal ultrasound, Diagnostic Test: Blood test AMHParticipants will not undergo any additional intervention compared to normal clinical assessment and routine testing of the ovarian reserve, which includes AMH and AFC. Investigators will follow standard stimulation protocols and medications. |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- All participants who visit ART Fertility clinics in Abu Dhabi, Al Ain and Dubai for first consultation
Key inclusion criteria (1 listed)
- 1. All participants with at least 1 previous pregnancy, who are assessed in one of our clinics (ART Fertility Clinics Abu Dhabi, Al Ain, Dubai)
Key exclusion criteria (7 listed)
- Severe male factor (azoospermia, cryptozoospermia, severe oligoasthenoteratozoospermia (OAT))
- Severe Endometriosis and adenomyosis based on positive anamnesis or ultrasound performed in our center during the first consultation
- Uterine abnormalities (e.g. fibroids, different degrees of uterine septum), diagnosed by ultrasound
- History of ovarian surgery, chemotherapy, or radiation therapy
- Known genetic disorder or chromosomal abnormality
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 |
|---|---|---|
| Transvaginal ultrasoundTransvaginal ultrasound for antral follicle count (AFC) performed on the day of first consultation | Diagnostic test | AMH <1.3, at least 1 pregnancy and no miscarriage, AMH <1.3, at least 1 pregnancy or at least 1 miscarriage, AMH ≥ 1.3, at least 1 pregnancy or at least 1 miscarriage, AMH ≥1.3, at least 1 pregnancy and no miscarriage |
| Blood test AMHMeasurement of AMH performed on the day of first consultation | Diagnostic test | AMH <1.3, at least 1 pregnancy and no miscarriage, AMH <1.3, at least 1 pregnancy or at least 1 miscarriage, AMH ≥ 1.3, at least 1 pregnancy or at least 1 miscarriage, AMH ≥1.3, at least 1 pregnancy and no miscarriage |
Primary outcome
AMH
Time frame: 1 day
Anti-Müllerian Hormone Test
AFC
Time frame: 1 day
Antral follicle count
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 33354626ESHRE working group on Ectopic Pregnancy; Kirk E, Ankum P, Jakab A, Le Clef N, Ludwin A, Small R, Tellum T, Toyli M, Van den Bosch T, Jurkovic D. Terminology for describing normally sited and ectopic pregnancies on ultrasound: ESHRE recommendations for good practice. Hum Reprod Open. 2020 Dec 16;2020(4):hoaa055. doi: 10.1093/hropen/hoaa055. eCollection 2020.
- Background: PubMed 35757430Tan J, Luo L, Jiang J, Yan N, Wang Q. Decreased Ovarian Reserves With an Increasing Number of Previous Early Miscarriages: A Retrospective Analysis. Front Endocrinol (Lausanne). 2022 Jun 10;13:859332. doi: 10.3389/fendo.2022.859332. eCollection 2022.
- Background: PubMed 37055255Bliddal S, Feldt-Rasmussen U, Forman JL, Hilsted LM, Larsen EC, Christiansen OB, Nielsen CH, Kolte AM, Nielsen HS. Anti-Mullerian hormone and live birth in unexplained recurrent pregnancy loss. Reprod Biomed Online. 2023 Jun;46(6):995-1003. doi: 10.1016/j.rbmo.2023.01.023. Epub 2023 Feb 3.
- Background: PubMed 1975901Stirrat GM. Recurrent miscarriage. II: Clinical associations, causes, and management. Lancet. 1990 Sep 22;336(8717):728-33. doi: 10.1016/0140-6736(90)92215-4.
- Background: PubMed 12620443Wang X, Chen C, Wang L, Chen D, Guang W, French J. Conception, early pregnancy loss, and time to clinical pregnancy: a population-based prospective study. Fertil Steril. 2003 Mar;79(3):577-84. doi: 10.1016/s0015-0282(02)04694-0.
- Background: PubMed 33915096Coomarasamy A, Dhillon-Smith RK, Papadopoulou A, Al-Memar M, Brewin J, Abrahams VM, Maheshwari A, Christiansen OB, Stephenson MD, Goddijn M, Oladapo OT, Wijeyaratne CN, Bick D, Shehata H, Small R, Bennett PR, Regan L, Rai R, Bourne T, Kaur R, Pickering O, Brosens JJ, Devall AJ, Gallos ID, Quenby S. Recurrent miscarriage: evidence to accelerate action. Lancet. 2021 May 1;397(10285):1675-1682. doi: 10.1016/S0140-6736(21)00681-4. Epub 2021 Apr 27.
- Background: PubMed 32145928Bunnewell SJ, Honess ER, Karia AM, Keay SD, Al Wattar BH, Quenby S. Diminished ovarian reserve in recurrent pregnancy loss: a systematic review and meta-analysis. Fertil Steril. 2020 Apr;113(4):818-827.e3. doi: 10.1016/j.fertnstert.2019.11.014. Epub 2020 Mar 4.
- Background: PubMed 33750616Seifer DB. Connecting the dots between oocyte quantity and quality in diminished ovarian reserve. Fertil Steril. 2021 Apr;115(4):890. doi: 10.1016/j.fertnstert.2021.01.020. Epub 2021 Mar 6. No abstract available.
- Background: PubMed 28865551Tarasconi B, Tadros T, Ayoubi JM, Belloc S, de Ziegler D, Fanchin R. Serum antimullerian hormone levels are independently related to miscarriage rates after in vitro fertilization-embryo transfer. Fertil Steril. 2017 Sep;108(3):518-524. doi: 10.1016/j.fertnstert.2017.07.001.
- Background: PubMed 29871793Lyttle Schumacher BM, Jukic AMZ, Steiner AZ. Antimullerian hormone as a risk factor for miscarriage in naturally conceived pregnancies. Fertil Steril. 2018 Jun;109(6):1065-1071.e1. doi: 10.1016/j.fertnstert.2018.01.039. Epub 2018 Jun 2.
- Background: PubMed 26806685Atasever M, Soyman Z, Demirel E, Gencdal S, Kelekci S. Diminished ovarian reserve: is it a neglected cause in the assessment of recurrent miscarriage? A cohort study. Fertil Steril. 2016 May;105(5):1236-1240. doi: 10.1016/j.fertnstert.2016.01.001. Epub 2016 Jan 21.
- Background: PubMed 31186176Leclercq E, de Saint Martin L, Bohec C, Le Martelot MT, Roche S, Alavi Z, Mottier D, Pasquier E. Blood anti-Mullerian hormone is a possible determinant of recurrent early miscarriage, yet not conclusive in predicting a further miscarriage. Reprod Biomed Online. 2019 Aug;39(2):304-311. doi: 10.1016/j.rbmo.2019.04.004. Epub 2019 Apr 12.
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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.
Laura Melado, PhD principal investigator
ART Fertility Clinics LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Miscarriage, run by ART Fertility Clinics LLC at 3 sites 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Lawrenz, PhD (+971 800 337845489, barbara.lawrenz@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT05969574, which also lists 13 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 25 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.