Clinical trial NCT02442895: Biomarkers of Ovarian Reserve and Correlation With IVF Treatments
Official title: Predictors of Ovarian Response in Women Undergoing Ovarian Stimulation for IVF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy, Ovarian
Keywords: mature oocytes
antral follicles count
follicle stimulating hormone
antimullerian hormone
Lead sponsor: U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 236
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with primary or secondary infertility who underwent ovarian stimulation for in vitro fertilization in our centre.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of total and mature (MII) oocytes
timeFrame: 10 months
Secondary outcomes:
measure: duration of stimulation
timeFrame: 10 months
measure: ovarian sensitivity index or OSI
timeFrame: 10 months
measure: pregnancy rate
timeFrame: 10 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico
Study officials:
affiliation: U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
name: Raffaella Depalo, MD
role: STUDY_DIRECTOR
References:
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;119(10):1171-9. doi: 10.1111/j.1471-0528.2012.03412.x. Epub 2012 Jul 17.
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 Sep;288(3):697-703. doi: 10.1007/s00404-013-2802-3. Epub 2013 Mar 26.
citation: Arce JC, La Marca A, Mirner Klein B, Nyboe Andersen A, Fleming R. Antimullerian hormone in gonadotropin releasing-hormone antagonist cycles: prediction of ovarian response and cumulative treatment outcome in good-prognosis patients. Fertil Steril. 2013 May;99(6):1644-53. doi: 10.1016/j.fertnstert.2012.12.048. Epub 2013 Feb 5.
citation: 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;26(12):3413-23. doi: 10.1093/humrep/der318. Epub 2011 Sep 27.
citation: Lan VT, Linh NK, Tuong HM, Wong PC, Howles CM. Anti-Mullerian 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.