Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?

NCT ID: NCT05969574

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2059 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-09

Study Completion Date

2025-12-31

Brief Summary

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This study aims to explore the potential correlation between decreased ovarian reserve and previous history of early miscarriage.

Detailed Description

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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

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Infertility, Female Miscarriage Miscarriage, Recurrent IVF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Transvaginal ultrasound

Intervention Type DIAGNOSTIC_TEST

Transvaginal ultrasound for antral follicle count (AFC) performed on the day of first consultation

Blood test AMH

Intervention Type DIAGNOSTIC_TEST

Measurement of AMH performed on the day of first consultation

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.

Transvaginal ultrasound

Intervention Type DIAGNOSTIC_TEST

Transvaginal ultrasound for antral follicle count (AFC) performed on the day of first consultation

Blood test AMH

Intervention Type DIAGNOSTIC_TEST

Measurement of AMH performed on the day of first consultation

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.

Transvaginal ultrasound

Intervention Type DIAGNOSTIC_TEST

Transvaginal ultrasound for antral follicle count (AFC) performed on the day of first consultation

Blood test AMH

Intervention Type DIAGNOSTIC_TEST

Measurement of AMH performed on the day of first consultation

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.

Transvaginal ultrasound

Intervention Type DIAGNOSTIC_TEST

Transvaginal ultrasound for antral follicle count (AFC) performed on the day of first consultation

Blood test AMH

Intervention Type DIAGNOSTIC_TEST

Measurement of AMH performed on the day of first consultation

Interventions

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Transvaginal ultrasound

Transvaginal ultrasound for antral follicle count (AFC) performed on the day of first consultation

Intervention Type DIAGNOSTIC_TEST

Blood test AMH

Measurement of AMH performed on the day of first consultation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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)

Exclusion Criteria

1. Severe male factor (azoospermia, cryptozoospermia, severe oligoasthenoteratozoospermia (OAT))
2. Severe Endometriosis and adenomyosis based on positive anamnesis or ultrasound performed in our center during the first consultation
3. Uterine abnormalities (e.g. fibroids, different degrees of uterine septum), diagnosed by ultrasound
4. History of ovarian surgery, chemotherapy, or radiation therapy
5. Known genetic disorder or chromosomal abnormality
6. BMI \>40Kg/m2
7. Currently using hormonal contraception or hormone replacement therapy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ART Fertility Clinics LLC

OTHER

Sponsor Role lead

Responsible Party

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Laura Melado

IVF Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Melado, PhD

Role: PRINCIPAL_INVESTIGATOR

ART Fertility Clinics LLC

Locations

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ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Site Status RECRUITING

ART Fertility Clinics Al Ain

Al Ain City, , United Arab Emirates

Site Status RECRUITING

ART Fertility Clinics Dubai

Dubai, , United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Barbara Lawrenz, PhD

Role: CONTACT

+971 800 337845489

Jonalyn Edades, RN

Role: CONTACT

+971 800 337845489

Facility Contacts

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Laura Melado, PhD

Role: primary

+971 800 337845489

Jonalyn Edades, RN

Role: backup

+971 800 337845489

Anastasia Salame, MD

Role: primary

+971 800 337845489

Carol Coughlan, PhD

Role: primary

+971 800 337845489

References

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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.

Reference Type BACKGROUND
PMID: 33354626 (View on PubMed)

Tan 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.

Reference Type BACKGROUND
PMID: 35757430 (View on PubMed)

Bliddal 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.

Reference Type BACKGROUND
PMID: 37055255 (View on PubMed)

Stirrat 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.

Reference Type BACKGROUND
PMID: 1975901 (View on PubMed)

Wang 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.

Reference Type BACKGROUND
PMID: 12620443 (View on PubMed)

Coomarasamy 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.

Reference Type BACKGROUND
PMID: 33915096 (View on PubMed)

Bunnewell 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.

Reference Type BACKGROUND
PMID: 32145928 (View on PubMed)

Seifer 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.

Reference Type BACKGROUND
PMID: 33750616 (View on PubMed)

Tarasconi 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.

Reference Type BACKGROUND
PMID: 28865551 (View on PubMed)

Lyttle 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.

Reference Type BACKGROUND
PMID: 29871793 (View on PubMed)

Atasever 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.

Reference Type BACKGROUND
PMID: 26806685 (View on PubMed)

Leclercq 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.

Reference Type BACKGROUND
PMID: 31186176 (View on PubMed)

Jaswa 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.

Reference Type BACKGROUND
PMID: 33583594 (View on PubMed)

Other Identifiers

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2305-ABU-007-LM

Identifier Type: -

Identifier Source: org_study_id

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