CClinicalTrials.gg
CompletedNCT02442895Updated May 13, 2015

Biomarkers of Ovarian Reserve and Correlation With IVF Treatments

An observational study in Pregnancy, Ovarian, sponsored by U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti. Completed at 1 site in Italy. Open to female participants. Per ClinicalTrials.gov, last updated 2015-05-13.

Sponsored by U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
236
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pregnancy, Ovarian

Keywords

  • mature oocytes
  • antral follicles count
  • follicle stimulating hormone
  • antimullerian hormone
03

In context

Lead sponsor

U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • women who underwent ovarian stimulation for cryopreservation in the presence of neoplastic disease.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
236 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. number of total and mature (MII) oocytes

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

    Time frame: 10 months

Secondary outcomes

  1. duration of stimulation

    the number of days since the administration of rFSH o corifollitropina alfa until the administration of hCG

    Time frame: 10 months

  2. ovarian sensitivity index or OSI

    OSI was calculated dividing the total administered FSH dose by the number of retrieved oocytes

    Time frame: 10 months

  3. pregnancy rate

    the number of positive pregnancy tests with the evidence of an embyo with cardiac activity.

    Time frame: 10 months

07

Study locations

1 site
  • Azienda Ospedaliero Universitaria Consorziale Policlinico
    Bari, 70124, Italy
08

References and documents

Publications

  • 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. PubMed 22805536 ↗
  • 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. PubMed 23529683 ↗
  • 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. PubMed 23394782 ↗
  • 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. PubMed 21954280 ↗
  • 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. PubMed 23953069 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02442895
Lead sponsor
U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti
Responsible party
Dr.ssa Raffaella Depalo (Director of U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti) — Principal investigator
First posted
May 13, 2015
Start date
Feb 2014
Primary completion
Dec 2014
Completion
Feb 2015
Last update
May 13, 2015

Study contacts

Raffaella Depalo, MD
study director · U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion