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

February 17, 2025 updated by: Laura Melado, ART Fertility Clinics LLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2059

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMH
Time Frame: 1 day
Anti-Müllerian Hormone Test
1 day
AFC
Time Frame: 1 day
Antral follicle count
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Laura Melado, PhD, ART Fertility Clinics LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 24, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2305-ABU-007-LM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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