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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05969574
• Other study ID #: 2305-ABU-007-LM
• Status: Recruiting
• Start date: September 9, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: ART Fertility Clinics LLC
• Contact: Barbara Lawrenz, PhD
• Phone: +971 800 337845489
• Email: barbara.lawrenz[@]artfertilityclinics.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2059
• Est. completion date: September 30, 2024
• Est. primary completion date: April 30, 2024
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Infertility
• Infertility, Female
• IVF
• Miscarriage
• Miscarriage, Recurrent

Intervention

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

Locations

Country	Name	City	State
United Arab Emirates	ART Fertility Clinics LLC	Abu Dhabi
United Arab Emirates	ART Fertility Clinics Al Ain	Al Ain
United Arab Emirates	ART Fertility Clinics Dubai	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
ART Fertility Clinics LLC

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMH	Anti-Müllerian Hormone Test	1 day
Primary	AFC	Antral follicle count	1 day