Biomarkers of Ovarian Reserve and Correlation With IVF Treatments

Pregnancy, Ovarian Clinical Trial

Official title:

Predictors of Ovarian Response in Women Undergoing Ovarian Stimulation for IVF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442895
• Other study ID #: Uospmacg2
• Status: Completed
• Phase: N/A
• First received: April 27, 2015
• Last updated: May 8, 2015
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Observational

Clinical Trial Summary

Retrospective study to evaluate the correlation between AFC, FSHb, AMH and IVF outcomes of 347 cycles performed with three different protocols.

Description:

347 IVF cycles (236 patients) analyzed for a retrospective study to evaluate the correlation between the biomarkers of ovarian reserve (antral follicles count, antimullerian hormone, basal follicle stimulating hormone) and number of oocytes and mature oocytes (MII) retrieved during the pick up. For the stimulation were used three different protocols: long luteal, antagonist with daily administration of gonadotropins and antagonist with depot administration of gonadotropins.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• women with primary or secondary infertility underwent ovarian stimulation for in vitro fertilization.

Exclusion Criteria:

• women who underwent ovarian stimulation for cryopreservation in the presence of neoplastic disease.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pregnancy, Ovarian

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Consorziale Policlinico	Bari

Sponsors (1)

Lead Sponsor	Collaborator
U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Andersen AN, Witjes H, Gordon K, Mannaerts B; Xpect investigators. Predictive factors of ovarian response and clinical outcome after IVF/ICSI following a rFSH/GnRH antagonist protocol with or without oral contraceptive pre-treatment. Hum Reprod. 2011 Dec; — View Citation

Arce JC, La Marca A, Mirner Klein B, Nyboe Andersen A, Fleming R. Antimüllerian hormone in gonadotropin releasing-hormone antagonist cycles: prediction of ovarian response and cumulative treatment outcome in good-prognosis patients. Fertil Steril. 2013 Ma — View Citation

La Marca A, Papaleo E, Grisendi V, Argento C, Giulini S, Volpe A. Development of a nomogram based on markers of ovarian reserve for the individualisation of the follicle-stimulating hormone starting dose in in vitro fertilisation cycles. BJOG. 2012 Sep;11 — View Citation

Lan VT, Linh NK, Tuong HM, Wong PC, Howles CM. Anti-Müllerian hormone versus antral follicle count for defining the starting dose of FSH. Reprod Biomed Online. 2013 Oct;27(4):390-9. doi: 10.1016/j.rbmo.2013.07.008. Epub 2013 Jul 23. — View Citation

Singh N, Bahadur A, Malhotra N, Kalaivani M, Mittal S. Prospective analysis of ovarian reserve markers as determinant in response to controlled ovarian stimulation in women undergoing IVF cycles in low resource setting in India. Arch Gynecol Obstet. 2013 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of total and mature (MII) oocytes	the number of total and mature (MII) oocytes retrieved during the pick up.	10 months	No
Secondary	duration of stimulation	the number of days since the administration of rFSH o corifollitropina alfa until the administration of hCG	10 months	No
Secondary	ovarian sensitivity index or OSI	OSI was calculated dividing the total administered FSH dose by the number of retrieved oocytes	10 months	No
Secondary	pregnancy rate	the number of positive pregnancy tests with the evidence of an embyo with cardiac activity.	10 months	No