Infertility, FemaleNCT06263192
Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles
An observational study of Infertility, Female and Anti-Mullerian Hormone Deficiency, run by Jose Antonio Moreno at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 39 years, women only
- Conditions the study is for
- Infertility, Female, Anti-Mullerian Hormone Deficiency
- What is being tested?
- Intrauterine insemination
- Type of treatment
- Surgery or procedure
- How many people
- 342 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2020to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 39 years
- Women only
- Adult
Study population: The study includes all patients between 25 and 39 years of age who have undergone IUI cycles with sperm donors
Who may be able to join
- 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.
Who cannot join
- BMI >30
- Infertility due to bilateral tubal factor
- Endometriosis grade II-IV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Intrauterine insemination
- Keywords
- anti-mullerian hormone, infertility, intrauterine insemination, sperm donation, cumulative pregnancy rates
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine inseminationProcedure or surgery
Intrauterine insemination with sperm donors
| Study group | Role | What they receive |
|---|---|---|
| AMH < 1.1 ng/ml | Not described Receives: Procedure: Intrauterine insemination | |
| AMH > 1.1 ng/ml | Not described Receives: Procedure: Intrauterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cummulative pregnancy rate
Pregnancy rate after 4 cycles of IUI
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Oct 2020
- Primary completion1 Dec 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Antonio Moreno
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona
- Responsible party
- Sponsor-investigator, Jose Antonio Moreno, Clinica de la Mujer Medicina Reproductiva, Chile
- Investigators
- Miguel Angel Checa, Study director, Fertty International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263192
- Sponsor's protocol ID
- AMH-IUI
- Status last verified
- Feb 2024
- First submitted
- 11 May 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38987421
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Prediction in Non-sterile Patients After 4 Intrauterine Inseminations With Donor Using Anti-Müllerian Hormone
- ClinicalTrials.gov ID
- NCT06263192
- Acronym / sponsor ID
- AMH-IUI
- Keywords
- anti-mullerian hormone, infertility, intrauterine insemination, sperm donation, cumulative pregnancy rates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Jose Antonio MorenoUniversity, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMH < 1.1 ng/ml | – | Procedure: Intrauterine insemination |
| AMH > 1.1 ng/ml | – | Procedure: Intrauterine insemination |
Who may qualify
- Ages
- 25 to 39 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study includes all patients between 25 and 39 years of age who have undergone IUI cycles with sperm donors
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- BMI >30
- Infertility due to bilateral tubal factor
- Endometriosis grade II-IV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrauterine inseminationIntrauterine insemination with sperm donors | Procedure or surgery | AMH < 1.1 ng/ml, AMH > 1.1 ng/ml |
Primary outcome
Cummulative pregnancy rate
Time frame: 36 months
Pregnancy rate after 4 cycles of IUI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Derived from this study: PubMed 38987421Gayete-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Angel Checa study director
Fertty International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Anti-Mullerian Hormone Deficiency, run by Jose Antonio Moreno at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cummulative pregnancy rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.