Pregnancy Prediction Using Anti-Müllerian Hormone in Intr... | NCT06263192

Studies
Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles

NCT06263192

Sponsor

Jose Antonio Moreno

Status

Completed

Last Update Posted

Feb 16, 2024Actual

Enrollment

342Actual

Phase

Not provided

Conditions

Infertility, Female
Anti-Mullerian Hormone Deficiency

Interventions

Intrauterine insemination

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

May 1, 2023Actual

First Submitted Date

May 11, 2023

First Submission Date that Met QC Criteria

Feb 8, 2024

First Posted Date

Feb 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2024

Last Update Posted Date

Feb 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jose Antonio Moreno, Principal Investigator, Clinica de la Mujer Medicina Reproductiva, ChileSponsor-Investigator

Lead Sponsor

Jose Antonio MorenoOTHER

Collaborators

Name	Class
Universitat Autonoma de Barcelona	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

342Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AMH < 1.1 ng/ml			Procedure: Intrauterine insemination
AMH > 1.1 ng/ml			Procedure: Intrauterine insemination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intrauterine insemination	Procedure	Intrauterine insemination with sperm donors	AMH < 1.1 ng/ml AMH > 1.1 ng/ml

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miguel Angel Checa	Fertty International	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fertty International		Barcelona		08010	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38987421	Derived	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.

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D007247	Infertility, Female
D007246	Infertility