Pregnancy, OvarianNCT02442895
Biomarkers of Ovarian Reserve and Correlation With IVF Treatments
An observational study of Pregnancy, Ovarian, run by U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti at 1 site in Italy.
Trial summary
Retrospective study to evaluate the correlation between AFC, FSHb, AMH and IVF outcomes of 347 cycles performed with three different protocols. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy, Ovarian
- Type of treatment
- Injection or infusion
- How many people
- 236 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with primary or secondary infertility who underwent ovarian stimulation for in vitro fertilization in our centre.
Who may be able to join
- women with primary or secondary infertility underwent ovarian stimulation for in vitro fertilization.
Who cannot join
- women who underwent ovarian stimulation for cryopreservation in the presence of neoplastic disease.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, Bari, 70124
About this study
Official title: Predictors of Ovarian Response in Women Undergoing Ovarian Stimulation for IVF
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.
- Conditions
- Pregnancy, Ovarian
- Keywords
- mature oocytes, antral follicles count, follicle stimulating hormone, antimullerian hormone
- Medical subject headings
- Pregnancy, Ovarian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of total and mature (MII) oocytes
the number of total and mature (MII) oocytes retrieved during the pick up.
Measured: 10 months
Secondary outcomes (3)
duration of stimulation
the number of days since the administration of rFSH o corifollitropina alfa until the administration of hCG
Measured: 10 months
ovarian sensitivity index or OSI
OSI was calculated dividing the total administered FSH dose by the number of retrieved oocytes
Measured: 10 months
pregnancy rate
the number of positive pregnancy tests with the evidence of an embyo with cardiac activity.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, OvarianStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.ssa Raffaella Depalo, U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti
- Investigators
- Raffaella Depalo, MD, Study director, U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442895
- Sponsor's protocol ID
- Uospmacg2
- Status last verified
- May 2015
- First submitted
- 27 Apr 2015
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
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 22805536Singh 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 23529683Arce 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 23394782Andersen 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 21954280Lan 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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Ovarian Response in Women Undergoing Ovarian Stimulation for IVF
- ClinicalTrials.gov ID
- NCT02442895
- Acronym / sponsor ID
- Uospmacg2
- Conditions
- Pregnancy, Ovarian
- Keywords
- mature oocytes, antral follicles count, follicle stimulating hormone, antimullerian hormone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- U.O.S. Procreazione Medicalmente Assistita e Congelamento GametiUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with primary or secondary infertility who underwent ovarian stimulation for in vitro fertilization in our centre.
Key inclusion criteria (1 listed)
- women with primary or secondary infertility underwent ovarian stimulation for in vitro fertilization.
Key exclusion criteria (1 listed)
- women who underwent ovarian stimulation for cryopreservation in the presence of neoplastic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of total and mature (MII) oocytes
Time frame: 10 months
the number of total and mature (MII) oocytes retrieved during the pick up.
3 secondary outcomes
duration of stimulation
Time frame: 10 months
ovarian sensitivity index or OSI
Time frame: 10 months
pregnancy rate
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
- Results publication: PubMed 22805536La 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.
- Results publication: PubMed 23529683Singh 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.
- Results publication: PubMed 23394782Arce 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.
- Results publication: PubMed 21954280Andersen 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.
- Results publication: PubMed 23953069Lan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaella Depalo, MD study director
U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, Ovarian, run by U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of total and mature (MII) oocytes (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02442895, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.