Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles

February 8, 2024 updated by: Jose Antonio Moreno

Pregnancy Prediction in Non-sterile Patients After 4 Intrauterine Inseminations With Donor Using Anti-Müllerian Hormone

The goal of this study is to compare the cumulative pregnancy rates after 4 artificial inseminations with donor (IAD) in non-sterile women with plasma AMH levels > and < 1.1 ng/mL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

342

Contacts and Locations

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

Study Locations

  • Spain
      • Barcelona, Spain, 08010
        • Fertty International

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

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The study includes all patients between 25 and 39 years of age who have undergone IUI cycles with sperm donors

Description

Inclusion Criteria:

  • IUI cycles with sperm donors either due to severe oligoasthenoteratozoospermia in the partner (defined as a motile sperm count (MSC) < 5 million in the ejaculate) or for social reasons, with up to 4 attempts accounted for.

Exclusion Criteria:

  • BMI >30
  • Infertility due to bilateral tubal factor
  • Endometriosis grade II-IV.

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 < 1.1 ng/ml
Procedure: Intrauterine insemination
Intrauterine insemination with sperm donors
AMH > 1.1 ng/ml
Procedure: Intrauterine insemination
Intrauterine insemination with sperm donors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cummulative pregnancy rate
Time Frame: 36 months
Pregnancy rate after 4 cycles of IUI
36 months

Collaborators and Investigators

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

Sponsor

Jose Antonio Moreno

Collaborators

Universitat Autonoma de Barcelona

Investigators

  • Study Director: Miguel Angel Checa, Fertty International

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)

October 1, 2020

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMH-IUI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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