Anti-Müllerian Hormone is Not Predictive of Pregnancy in Donor Insemination Cycles in Non-infertile Women

NCT03160872 | Completed

• 1 other identifier: SMD-2016-033
• Study Type: observational
• Target: 143
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Infertility

Keywords

Donor sperm insemination; Anti Mullerian Hormone; Ovarian reserve; Antral follicle count

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy

  Clinical Pregnancy evaluated by ultrasound with fetal heart beat

  6 weeks after insemination procedure

Secondary Outcomes (1)

• Miscarriage rate

  Evaluated until 15 weeks after insemination procedure

Study Arms (1)

Women who undergo donor sperm insemination

Non infertile women who undergo donor sperm insemination cycle

Diagnostic Test: Anti Mullerian Hormone Measurement

Interventions

Anti Mullerian Hormone Measurement DIAGNOSTIC_TEST

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

Women who undergo donor sperm insemination

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• previous history of infertility.
• Presence of any gynaecological condition that could impair the inseminations results:
• endometriosis, hydrosalpinx,…

Sponsors & Collaborators

• Fundacion Dexeus: lead

Related Publications (3)

• 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.

  PMID: 28285954 BACKGROUND

• 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-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.

  PMID: 26965431 BACKGROUND

• 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-Mullerian hormone in subfertile women. Acta Obstet Gynecol Scand. 2015 Dec;94(12):1307-12. doi: 10.1111/aogs.12761. Epub 2015 Sep 16.

  PMID: 26332870 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: January 1, 2013
• Primary Completion: June 30, 2016
• Study Completion: December 15, 2016
• Last Updated: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share