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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03160872
Other study ID # SMD-2016-033
Secondary ID
Status Completed
Phase N/A
First received May 18, 2017
Last updated May 18, 2017
Start date January 1, 2013
Est. completion date December 15, 2016

Study information

Verified date May 2017
Source Institut Universitari Dexeus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date December 15, 2016
Est. primary completion date June 30, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 43 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- previous history of infertility.

- Presence of any gynaecological condition that could impair the inseminations results:

- endometriosis, hydrosalpinx,…

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Anti Mullerian Hormone Measurement
Anti Mullerian Hormone was measured in all patients within two months before the first insemination cycle

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Institut Universitari Dexeus

References & Publications (3)

Catteau-Jonard S, Roux M, Dumont A, Delesalle AS, Robin G, Dewailly D. Anti-Müllerian 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. — View Citation

Hvidman 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-Müllerian 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. — View Citation

Somigliana E, Lattuada D, Colciaghi B, Filippi F, La Vecchia I, Tirelli A, Baffero GM, Paffoni A, Persico N, Bolis G, Fedele L. Serum anti-Müllerian hormone in subfertile women. Acta Obstet Gynecol Scand. 2015 Dec;94(12):1307-12. doi: 10.1111/aogs.12761. Epub 2015 Sep 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Pregnancy Clinical Pregnancy evaluated by ultrasound with fetal heart beat 6 weeks after insemination procedure
Secondary Miscarriage rate Number of clinical miscarriage after clinical pregnancy Evaluated until 15 weeks after insemination procedure
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