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Recruiting NCT05969574

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

Observational Infertility, Female Miscarriage Miscarriage, Recurrent IVF

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transvaginal ultrasound, Blood test AMH.
Who it may be relevant to
Registry conditions: Infertility, Female, Miscarriage, Miscarriage, Recurrent, IVF. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Arab Emirates
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages? A Prospective Observational Study

Overview

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.

Interventions

  • Diagnostic test Transvaginal ultrasound
    Transvaginal ultrasound for antral follicle count (AFC) performed on the day of first consultation
  • Diagnostic test Blood test AMH
    Measurement of AMH performed on the day of first consultation

Primary outcome measures

  • AMH [Time frame: 1 day]
  • AFC [Time frame: 1 day]

Eligibility criteria

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United Arab Emirates · 3 centers
  • ART Fertility Clinics LLC — Abu Dhabi
  • ART Fertility Clinics Al Ain — Al Ain City
  • ART Fertility Clinics Dubai — Dubai

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. PMID 33354626
  • 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. PMID 35757430
  • 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. PMID 37055255
  • 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. PMID 1975901
  • 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. PMID 12620443
  • 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: PMID 33915096
  • 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. PMID 32145928
  • 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. PMID 33750616

Identifiers

NCT: NCT05969574 · 2305-ABU-007-LM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗