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

Sponsor
ART Fertility Clinics LLC (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05969574
Collaborator
(none)
2,059
3
13.5
686.3
50.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Transvaginal ultrasound
  • Diagnostic Test: Blood test AMH

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 Design

Study Type:
Observational
Anticipated Enrollment :
2059 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages? A Prospective Observational Study
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. AMH [1 day]

    Anti-Müllerian Hormone Test

  2. AFC [1 day]

    Antral follicle count

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ART Fertility Clinics LLC Abu Dhabi United Arab Emirates 60202
2 ART Fertility Clinics Al Ain Al Ain United Arab Emirates
3 ART Fertility Clinics Dubai Dubai United Arab Emirates

Sponsors and Collaborators

  • ART Fertility Clinics LLC

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Laura Melado, IVF Specialist, ART Fertility Clinics LLC
ClinicalTrials.gov Identifier:
NCT05969574
Other Study ID Numbers:
  • 2305-ABU-007-LM
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Laura Melado, IVF Specialist, ART Fertility Clinics LLC
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2023