InfertilityNCT03160872
Anti-Müllerian Hormone is Not Predictive of Pregnancy in Donor Insemination Cycles in Non-infertile Women
An observational study of Infertility, run by Fundacion Dexeus.
Trial summary
To evaluate if ovarian reserve (measured by means of anti-mullerian hormone -AMH- and antral follicle count -AFC-) can predict pregnancy in donor insemination cycles (dIUI) performed in non-infertile women. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Anti Mullerian Hormone Measurement
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 15 Dec 2016
- 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 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Non Infertile women who undergo a donor sperm insemination due to absence of male partner or complete azoospermia or the presence of a genetic condition in the partner that made the couple opt for donor sperm.
Who may be able to join
- absence of male partner
- complete azoospermia or the presence of a genetic condition in the partner that made the couple opt for donor sperm
- absence of previous history of infertility.
- d ta on AMH and AFC assessment before the first dIUI cycle.
Who cannot join
- previous history of infertility.
- Presence of any gynaecological condition that could impair the inseminations results:
- endometriosis, hydrosalpinx,…
About this study
Official title: Ovarian Reserve Does Not Predict Pregnancy in Non-Infertile Women: An Assessment Using the Donor Sperm Insemination Model
To evaluate if ovarian reserve (measured by means of anti-mullerian hormone -AMH- and antral follicle count -AFC-) can predict pregnancy in donor insemination cycles (dIUI) performed in non-infertile women.
- Conditions
- Infertility
- Being tested
- Anti Mullerian Hormone Measurement
- Keywords
- Donor sperm insemination, Anti Mullerian Hormone, Ovarian reserve, Antral follicle count
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti Mullerian Hormone MeasurementDiagnostic test
Anti Mullerian Hormone was measured in all patients within two months before the first insemination cycle
| Study group | Role | What they receive |
|---|---|---|
| Women who undergo donor sperm insemination | Non infertile women who undergo donor sperm insemination cycle Receives: Diagnostic Test: Anti Mullerian Hormone Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy
Clinical Pregnancy evaluated by ultrasound with fetal heart beat
Measured: 6 weeks after insemination procedure
Secondary outcomes (1)
Miscarriage rate
Number of clinical miscarriage after clinical pregnancy
Measured: Evaluated until 15 weeks after insemination procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Jan 2013
- Primary completion30 Jun 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Retrospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iñaki González Foruria, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160872
- Sponsor's protocol ID
- SMD-2016-033
- Status last verified
- May 2017
- First submitted
- 18 May 2017
- Last updated
- 19 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Catteau-Jonard S, Roux M, Dumont A, Delesalle AS, Robin G, Dewailly D. Anti-Mullerian hormone concentrations and parity in fertile women: the model of oocyte donors. Reprod Biomed Online. 2017 May;34(5):541-545. doi: 10.1016/j.rbmo.2017.02.010. Epub 2017 Mar 1.
PubMed 28285954Hvidman HW, Bentzen JG, Thuesen LL, Lauritsen MP, Forman JL, Loft A, Pinborg A, Nyboe Andersen A. Infertile women below the age of 40 have similar anti-Mullerian hormone levels and antral follicle count compared with women of the same age with no history of infertility. Hum Reprod. 2016 May;31(5):1034-45. doi: 10.1093/humrep/dew032. Epub 2016 Mar 9.
PubMed 26965431Somigliana E, Lattuada D, Colciaghi B, Filippi F, La Vecchia I, Tirelli A, Baffero GM, Paffoni A, Persico N, Bolis G, Fedele L. Serum anti-Mullerian hormone in subfertile women. Acta Obstet Gynecol Scand. 2015 Dec;94(12):1307-12. doi: 10.1111/aogs.12761. Epub 2015 Sep 16.
PubMed 26332870
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Reserve Does Not Predict Pregnancy in Non-Infertile Women: An Assessment Using the Donor Sperm Insemination Model
- ClinicalTrials.gov ID
- NCT03160872
- Acronym / sponsor ID
- SMD-2016-033
- Conditions
- Infertility
- Keywords
- Donor sperm insemination, Anti Mullerian Hormone, Ovarian reserve, Antral follicle count
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 19 May 2017 (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.
To evaluate if ovarian reserve (measured by means of anti-mullerian hormone -AMH- and antral follicle count -AFC-) can predict pregnancy in donor insemination cycles (dIUI) performed in non-infertile women.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women who undergo donor sperm insemination | – | Diagnostic Test: Anti Mullerian Hormone MeasurementNon infertile women who undergo donor sperm insemination cycle |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Non Infertile women who undergo a donor sperm insemination due to absence of male partner or complete azoospermia or the presence of a genetic condition in the partner that made the couple opt for donor sperm.
Key inclusion criteria (4 listed)
- absence of male partner
- complete azoospermia or the presence of a genetic condition in the partner that made the couple opt for donor sperm
- absence of previous history of infertility.
- d ta on AMH and AFC assessment before the first dIUI cycle.
Key exclusion criteria (3 listed)
- previous history of infertility.
- Presence of any gynaecological condition that could impair the inseminations results:
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 |
|---|---|---|
| Anti Mullerian Hormone MeasurementAnti Mullerian Hormone was measured in all patients within two months before the first insemination cycle | Diagnostic test | Women who undergo donor sperm insemination |
Primary outcome
Clinical Pregnancy
Time frame: 6 weeks after insemination procedure
Clinical Pregnancy evaluated by ultrasound with fetal heart beat
1 secondary outcome
Miscarriage rate
Time frame: Evaluated until 15 weeks after insemination procedure
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 19 May 2017.
- Background: PubMed 28285954Catteau-Jonard S, Roux M, Dumont A, Delesalle AS, Robin G, Dewailly D. Anti-Mullerian hormone concentrations and parity in fertile women: the model of oocyte donors. Reprod Biomed Online. 2017 May;34(5):541-545. doi: 10.1016/j.rbmo.2017.02.010. Epub 2017 Mar 1.
- Background: PubMed 26965431Hvidman HW, Bentzen JG, Thuesen LL, Lauritsen MP, Forman JL, Loft A, Pinborg A, Nyboe Andersen A. Infertile women below the age of 40 have similar anti-Mullerian hormone levels and antral follicle count compared with women of the same age with no history of infertility. Hum Reprod. 2016 May;31(5):1034-45. doi: 10.1093/humrep/dew032. Epub 2016 Mar 9.
- Background: PubMed 26332870Somigliana E, Lattuada D, Colciaghi B, Filippi F, La Vecchia I, Tirelli A, Baffero GM, Paffoni A, Persico N, Bolis G, Fedele L. Serum anti-Mullerian hormone in subfertile women. Acta Obstet Gynecol Scand. 2015 Dec;94(12):1307-12. doi: 10.1111/aogs.12761. Epub 2015 Sep 16.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Fundacion Dexeus.
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 4 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical Pregnancy (time frame: 6 weeks after insemination procedure). 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 NCT03160872, which also lists 3 linked publications.
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 19 May 2017.