NCT06263192

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2023

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

May 11, 2023

Last Update Submit

February 8, 2024

Conditions

Infertility, FemaleAnti-Mullerian Hormone Deficiency

Keywords

anti-mullerian hormoneinfertilityintrauterine inseminationsperm donationcumulative pregnancy rates

Outcome Measures

Primary Outcomes (1)

  • Cummulative pregnancy rate

    Pregnancy rate after 4 cycles of IUI

    36 months

Study Arms (2)

AMH < 1.1 ng/ml

Procedure: Intrauterine insemination

AMH > 1.1 ng/ml

Procedure: Intrauterine insemination

Interventions

Intrauterine inseminationPROCEDURE

Intrauterine insemination with sperm donors

AMH < 1.1 ng/mlAMH > 1.1 ng/ml

Eligibility Criteria

Age25 Years - 39 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertty International

Barcelona, 08010, Spain

Location

Related Publications (1)

  • Gayete-Lafuente S, Moreno-Sepulveda J, Sanchez-Alvarez J, Prat M, Robles A, Espinos JJ, Checa MA. Anti-Mullerian hormone does not predict cumulative pregnancy rate in non-infertile women following four IUI cycles with donor sperm. J Assist Reprod Genet. 2024 Sep;41(9):2319-2326. doi: 10.1007/s10815-024-03188-5. Epub 2024 Jul 10.

    PMID: 38987421DERIVED

MeSH Terms

Conditions

Infertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Miguel Angel Checa

    Fertty International

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2023

First Posted

February 16, 2024

Study Start

October 1, 2020

Primary Completion

December 1, 2022

Study Completion

May 1, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

ES(1)