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

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ClinicalTrials.gov Identifier: NCT05969574
Recruitment Status : Recruiting
First Posted : August 1, 2023
Last Update Posted : November 24, 2023
Sponsor:
Information provided by (Responsible Party):
Laura Melado, ART Fertility Clinics LLC

Study Description
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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
Infertility, Female Miscarriage Miscarriage, Recurrent IVF 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
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Study Type : Observational
Estimated 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
Actual Study Start Date : September 9, 2023
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. AMH [ Time Frame: 1 day ]
    Anti-Müllerian Hormone Test

  2. AFC [ Time Frame: 1 day ]
    Antral follicle count


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All participants who visit ART Fertility clinics in Abu Dhabi, Al Ain and Dubai for first consultation
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:

  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
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05969574


Contacts
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Contact: Barbara Lawrenz, PhD +971 800 337845489 barbara.lawrenz@artfertilityclinics.com
Contact: Jonalyn Edades, RN +971 800 337845489 jonalyn.edades@artfertilityclinics.com

Locations
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United Arab Emirates
ART Fertility Clinics LLC Recruiting
Abu Dhabi, United Arab Emirates, 60202
Contact: Laura Melado, PhD    +971 800 337845489    laura.melado@artfertilityclinics.com   
Contact: Jonalyn Edades, RN    +971 800 337845489    jonalyn.edades@artfertilityclinics.com   
Principal Investigator: Laura Melado, PhD         
ART Fertility Clinics Al Ain Recruiting
Al Ain, United Arab Emirates
Contact: Anastasia Salame, MD    +971 800 337845489    jonalyn.edades@artfertilityclinics.com   
ART Fertility Clinics Dubai Recruiting
Dubai, United Arab Emirates
Contact: Carol Coughlan, PhD    +971 800 337845489    jonalyn.edades@artfertilityclinics.com   
Sponsors and Collaborators
ART Fertility Clinics LLC
Investigators
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Principal Investigator: Laura Melado, PhD ART Fertility Clinics LLC
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: Laura Melado, IVF Specialist, ART Fertility Clinics LLC
ClinicalTrials.gov Identifier: NCT05969574    
Other Study ID Numbers: 2305-ABU-007-LM
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: November 24, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Melado, ART Fertility Clinics LLC:
miscarriage
infertility
IVF
Additional relevant MeSH terms:
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Infertility
Abortion, Spontaneous
Infertility, Female
Abortion, Habitual
Genital Diseases
 Urogenital Diseases
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Genital Diseases, Female
Female Urogenital Diseases