Biomarkers of Ovarian Reserve and Correlation With IVF Treatments

NCT02442895 | Completed

• 1 other identifier: Uospmacg2
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy, Ovarian

Keywords

mature oocytes; antral follicles count; follicle stimulating hormone; antimullerian hormone

Outcome Measures

Primary Outcomes (1)

• number of total and mature (MII) oocytes

  the number of total and mature (MII) oocytes retrieved during the pick up.

  10 months

Secondary Outcomes (3)

• duration of stimulation

  10 months

• ovarian sensitivity index or OSI

  10 months

• pregnancy rate

  10 months

Study Arms (3)

Long luteal protocol

Subcutaneous administration of GnRH agonist (Triptorelina pamoato 0.1 mg/ml) in the medium-luteal phase (21th day) of the cycle before the stimulation. The next menstruation, in the presence of estradiol level (E2)\<30pg/ml and in the absence of follicular cysts, the gonadotropin stimulation was begun. In the presence of at least three follicles of diameter ≥18mm was induced final oocyte maturation by administration of human chorionic gonadotropin (hCG).

Daily antagonist protocol

GnRH antagonist (cetrorelix acetate 0.25 mg) was administered subcutaneously with a fixed protocol from the day +6 of stimulation or with a flexible protocol from the day in which at least one follicle reached a diameter of 14mm. In both protocols GnRH antagonist was administered until the day of the assumption of hCG. Recombinant Follicle Stimulating Hormone (rFSH) was administered from the 3rd day of menstruation at a dose of 150-300 IU/die according to the characteristics of women. The hCG was administered when at least three follicles had reached 18 mm in diameter and estradiol levels were higher than 150 pg/mL/dominant follicle.

Depot antagonist protocol

GnRH antagonist (Cetrorelix acetate 0.25 mg) was administered subcutaneously with a fixed or flexible protocol until the day of the assumption of hCG. Corifollitropila alfa was used at dose of 100μg (in women with weight ≤60 kg and age ≤36 years) or 150μg (in women with weight\> 60 kg of any age or weight ≥50 kg and age greater than 36 years). Corifollitropina alfa was administered subcutaneously in the day +3 and in the day +5 or +6 was supplemented with rFSH at doses 112-300 IU/day. The hCG was administered when at least three follicles had reached 18 mm in diameter and estradiol levels were higher than 150 pg/mL/dominant follicle.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with primary or secondary infertility who underwent ovarian stimulation for in vitro fertilization in our centre.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Consorziale Policlinico

Bari, Bari, 70124, Italy

Location

Related Publications (5)

• 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.

  PMID: 22805536 RESULT

• 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.

  PMID: 23529683 RESULT

• 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.

  PMID: 23394782 RESULT

• 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.

  PMID: 21954280 RESULT

• 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.

  PMID: 23953069 RESULT

MeSH Terms

Conditions

Pregnancy, Ovarian

Condition Hierarchy (Ancestors)

Pregnancy, Ectopic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Raffaella Depalo, MD

  U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 13, 2015
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

IT (1)