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

NCT05969574 | Recruiting DMC

• 1 other identifier: 2305-ABU-007-LM
• Study Type: observational
• Target: 2,059
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Infertility, Female; Miscarriage; Miscarriage, Recurrent; IVF

Keywords

miscarriage; infertility; IVF

Outcome Measures

Primary Outcomes (2)

• AMH

  Anti-Müllerian Hormone Test

  1 day

• AFC

  Antral follicle count

  1 day

Study Arms (4)

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.

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.

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.

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.

Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Blood test AMH

Interventions

Transvaginal ultrasound DIAGNOSTIC_TEST

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

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 AMH DIAGNOSTIC_TEST

Measurement of AMH performed on the day of first consultation

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

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants who visit ART Fertility clinics in Abu Dhabi, Al Ain and Dubai for first consultation

You may qualify if:

• \. All participants with at least 1 previous pregnancy, who are assessed in one of our clinics (ART Fertility Clinics Abu Dhabi, Al Ain, Dubai)

You may not qualify if:

• 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

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (3)

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

RECRUITING

ART Fertility Clinics Al Ain

Al Ain City, United Arab Emirates

RECRUITING

ART Fertility Clinics Dubai

Dubai, United Arab Emirates

RECRUITING

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 33915096 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 28865551 BACKGROUND

• 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.

  PMID: 29871793 BACKGROUND

• 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.

  PMID: 26806685 BACKGROUND

• 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.

  PMID: 31186176 BACKGROUND

• 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.

  PMID: 33583594 BACKGROUND

MeSH Terms

Conditions

Infertility, Female; Abortion, Spontaneous; Abortion, Habitual; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pregnancy Complications

Study Officials

• Laura Melado, PhD

  ART Fertility Clinics LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Lawrenz, PhD

CONTACT

+971 800 337845489; barbara.lawrenz@artfertilityclinics.com

Jonalyn Edades, RN

CONTACT

+971 800 337845489; jonalyn.edades@artfertilityclinics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IVF Specialist

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: September 9, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AE (3)