Ovarian ReserveNCT03009370
The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss
An observational study of Ovarian Reserve and Miscarriage, Recurrent, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether ovarian reserve is related to recurrent pregnancy loss Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Reserve, Miscarriage, Recurrent
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2016to Mar 2017
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Recurrent miscarriage is defined as three or more pregnancy loss at<20 weeks of gestation.The women between 20 -40 years old with history of RM are recruited.
Who may be able to join
- Women with RM between 20-40 years old
Who cannot join
- Anovulation or PCOS
- Presence of endometrosis by laparoscopy or ultrasonography
- History of ovarian surgery
- Tobacco use
- Systemic chemotherapy
- Pelvic irradition
Show all 9Show fewer
- Genetic abnormalities
- Irregular menstruel cycle
- family history of premature ovarian failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Istanbul, 34325
About this study
The purpose of this study is to determine whether ovarian reserve is related to recurrent pregnancy loss
Read the detailed description
This study will be conducted at the gynecology and infertility department of Kanuni Sultan Süleyman Training and Research Hospital from 2016 to 2017. The approval of the local Institutional Review Board (KAEK/2016.22.31) was obtained in June 2016 and informed consents of all subjects have been prepared. RM is defined as three or more pregnancy losses at <20 weeks of gestation or fetal weight <500 g. Women with history of RM for whom routine workup for RM (chromosomal analyses of both partners; levels of prolactin and TSH; anticardiolipin antibody, lupus anticoagulant, antinuclear antibody, and coagulation studies; and pelvic ultrasonography) is negative are assigned to the RM group. The control group consists of healthy women with no history of RM who are seeking contraception in the center's family planning unit. To keep the power of the study at 80% with an alpha-level of 0.05, a sample size of minumum 60 patients in each group was required.
Demographic data (age,gravidity,parity,pregnancy loss,bmı) ovarian reserve parameters(AMH,FSH,LH,E2,AFC) will be recorded and then two groups will be compared.
Data will be analyzed with the use of medcalc version 16.4.8 by Gökhan Yıldırım. Mean,median,SD,lowest and highest frequency ,and ratio values are used at statistical complementary of data .Quantitative data will be analyzed with the use of the Student t test and the Mann-Whitney U test. A chisquare test will be used for analyses of qualitative data
- Conditions
- Ovarian Reserve, Miscarriage, Recurrent
- Keywords
- Ovarian reserve, pregnancy loss
- Medical subject headings
- Abortion, Habitual
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 |
|---|---|---|
| Recurrent miscarriage | RM is defined as three or more pregnancy losses at< 20 weeks of gestation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the ovarian reserve on the recurrent pregnancy loss
Venous blood samples will be taken from the antecubital regions of all patients between 8:00 a.m and 9:00 a.m during the early follicular phase (days 2-4) of the menstrual cycle .Serum samples will be stored at -80C and assayed for FSH,LH,E2 and AMH .FSH levels are analyzed by means of an electrochemiluminescence method .The normal range for FSH is 2.5-10 U/L at the early follicular phase. Serum AMH levels will be measured with the use of a human ELİSA kit . The normal range for this assay is 0.05-1.5 ng/ml.In the same morning that the blood tests are performed , the total number of antral follicles measuring 2-10 mm in diameter are evaluated by the operator.A 7.5 -MHz transvaginal probe is used in all examinations.Data will be analyzed with the use of medcalc.
Measured: up to 6 months
Secondary outcomes (1)
Ovarian reserve tests can be used for the diagnosis of the cause of recurrent pregnancy loss
FSH,LH,E2,AMH assesment of at least 86 patients will be analyzed with the use of medcalc . Unıts of measure of FSH,LH,E2 levels are assesed by U/L. The normal range of AMH level is 0.05-1.5ng/ml. Mean ,median ,SD, lowest and highest frequency ,and ratio values are used at statistical complemantary data.Quantitative data are analyzed with the use of the student -t test and Mann-Whitney U test
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian ReserveStudies 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
- Cross-sectional
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Yetkin Yildirim, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Gonca Yetkin Yıdırım, MD, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009370
- Sponsor's protocol ID
- KanuniSSSTRH
- Status last verified
- Dec 2016
- First submitted
- 18 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Atasever M, Soyman Z, Demirel E, Gencdal S, Kelekci S. Diminished ovarian reserve: is it a neglected cause in the assessment of recurrent miscarriage? A cohort study. Fertil Steril. 2016 May;105(5):1236-1240. doi: 10.1016/j.fertnstert.2016.01.001. Epub 2016 Jan 21.
PubMed 26806685
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT03009370
- Acronym / sponsor ID
- KanuniSSSTRH
- Conditions
- Ovarian Reserve, Miscarriage, Recurrent
- Keywords
- Ovarian reserve, pregnancy loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 4 Jan 2017 (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.
The purpose of this study is to determine whether ovarian reserve is related to recurrent pregnancy loss
Detailed description
This study will be conducted at the gynecology and infertility department of Kanuni Sultan Süleyman Training and Research Hospital from 2016 to 2017. The approval of the local Institutional Review Board (KAEK/2016.22.31) was obtained in June 2016 and informed consents of all subjects have been prepared. RM is defined as three or more pregnancy losses at <20 weeks of gestation or fetal weight <500 g. Women with history of RM for whom routine workup for RM (chromosomal analyses of both partners; levels of prolactin and TSH; anticardiolipin antibody, lupus anticoagulant, antinuclear antibody, and coagulation studies; and pelvic ultrasonography) is negative are assigned to the RM group. The control group consists of healthy women with no history of RM who are seeking contraception in the center's family planning unit. To keep the power of the study at 80% with an alpha-level of 0.05, a sample size of minumum 60 patients in each group was required.
Demographic data (age,gravidity,parity,pregnancy loss,bmı) ovarian reserve parameters(AMH,FSH,LH,E2,AFC) will be recorded and then two groups will be compared.
Data will be analyzed with the use of medcalc version 16.4.8 by Gökhan Yıldırım. Mean,median,SD,lowest and highest frequency ,and ratio values are used at statistical complementary of data .Quantitative data will be analyzed with the use of the Student t test and the Mann-Whitney U test. A chisquare test will be used for analyses of qualitative data
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent miscarriage | – | –RM is defined as three or more pregnancy losses at< 20 weeks of gestation. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Recurrent miscarriage is defined as three or more pregnancy loss at<20 weeks of gestation.The women between 20 -40 years old with history of RM are recruited.
Key inclusion criteria (1 listed)
- Women with RM between 20-40 years old
Key exclusion criteria (9 listed)
- Anovulation or PCOS
- Presence of endometrosis by laparoscopy or ultrasonography
- History of ovarian surgery
- Tobacco use
- Systemic chemotherapy
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
The effect of the ovarian reserve on the recurrent pregnancy loss
Time frame: up to 6 months
Venous blood samples will be taken from the antecubital regions of all patients between 8:00 a.m and 9:00 a.m during the early follicular phase (days 2-4) of the menstrual cycle .Serum samples will be stored at -80C and assayed for FSH,LH,E2 and AMH .FSH levels are analyzed by means of an electrochemiluminescence method .The normal range for FSH is 2.5-10 U/L at the early follicular phase. Serum AMH levels will be measured with the use of a human ELİSA kit . The normal range for this assay is 0.05-1.5 ng/ml.In the same morning that the blood tests are performed , the total number of antral follicles measuring 2-10 mm in diameter are evaluated by the operator.A 7.5 -MHz transvaginal probe is used in all examinations.Data will be analyzed with the use of medcalc.
1 secondary outcome
Ovarian reserve tests can be used for the diagnosis of the cause of recurrent pregnancy loss
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Results publication: PubMed 26806685Atasever M, Soyman Z, Demirel E, Gencdal S, Kelekci S. Diminished ovarian reserve: is it a neglected cause in the assessment of recurrent miscarriage? A cohort study. Fertil Steril. 2016 May;105(5):1236-1240. doi: 10.1016/j.fertnstert.2016.01.001. Epub 2016 Jan 21.
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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.
Gonca Yetkin Yıdırım, MD study director
Saglik Bilimleri Universitesi
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 Ovarian Reserve and Miscarriage, Recurrent, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 9 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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gonca Yetkin Yıldırım, MD (+90 5323532205, goncayetkinyildirim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of the ovarian reserve on the recurrent pregnancy loss (time frame: up to 6 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 NCT03009370, which also lists 1 linked publication.
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 4 Jan 2017.