Polycystic Ovary SyndromeNCT04528849
Comparison of Ovulation Induction Cycle Outcomes Between Early and Late Dose Increments for Low Dose Gonadotropin Step-up Protocol Among Infertile Women Diagnosed With Polycystic Ovary Syndrome: Prospective Randomised Trial
A study testing Gonadotropin dose increment timing in people with Polycystic Ovary Syndrome and Infertility, Female, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 21 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Infertility, Female
- What is being tested?
- Gonadotropin dose increment timing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2020to 20 Aug 2022
- Phase
- Interventional
- 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 21 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria:Infertile women who have been diagnosed with PCOS based on Rotterdam criteriae and who have not succeeded to get pregnant by using oral ovulation induction agents and whose BMI levels are <30 kg/m2 will be included to the study.
Exclusion Criteria:Infertile women with tubal diseases, male factor infertility, endometriosis, previous pelvic surgery history, chronic systemic disease, BMI levels>30 kg/m2 and who are not voluntary to attend to the study will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences, Ankara City Hospital, Department of Reproductive Endocrinology
Ankara
Serkan Kahyaoglu, M.D, +905058868040, serkan.kahyaoglu@sbu.edu.tr
Serkan Kahyaoglu, M.D
About this study
Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome (PCOS). First dose increment is advised on 14th day of ovarian stimulation with gonadotropins to decrease multiple follicle generation and cycle cancellation rates. However, clinicians impatiently increase gonadotropin dose on 7th day of stimulation without strong scientific evidence. This randomised controlled study will be the first study which will compare safety and ovulation induction cyle outcomes of early and late dose increments among infertile women diagnosed with PCOS.
Read the detailed description
Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome. First dose increment is advised on 14th day of ovarian stimulation with gonadotropins to decrease multiple follicle generation and cycle cancellation rates. However, clinicians impatiently increase gonadotropin dose on 7th day of stimulation without strong scientific evidence. This randomised controlled study will be the first study which will compare safety and ovulation induction cyle outcomes of early and late dose increments among infertile women diagnosed with polycystic ovary syndrome.
We will start low dose step-up ovulation induction treatment by using 50 IU recombinant FSH for 21-39 years old non- obese patients (BMI <30 kg/m2) diagnosed with PCOS and . We will perform folliculometry on 7th day of ovulation induction. In case of absence for at least one >10 mm dominant follicle, we will randomise these women by using blind envelope selection method for assignment of early or late dose incerement groups. Half of the patients will receive 25 IU dose increment on 7th day of ovulation induction, remaining half will receive dose increment on 14th day of ovulation induction. We will continue ovarian stimulation without any other dose increment until 35th day of stimulation as deadline time restriction. We will perform folliculometry and serum estradiol measurement intermittently during ovulation induction. We will record ovulation induction cycle outcomes and clinical pregnancy results of the study group following finalization for treatment cyle of each patient. We will compare ovulation induction cycle outcomes of these two dose increment groups.
- Conditions
- Polycystic Ovary Syndrome, Infertility, Female
- Being tested
- Gonadotropin dose increment timing
- Keywords
- Polycystic ovary syndrome, Infertility, Low dose step-up, Gonadotropin, Ovulation induction
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotropin dose increment timingDrug
Gonadotropin dose increments of 25 IU will be utilized on 7th and 14th day of ovulation induction for each study group.
| Study group | Role | What they receive |
|---|---|---|
| Early dose increment | Active comparator | Patients who have received 25 IU gonadotropin dose increment on 7th day of ovulation induction Receives: Drug: Gonadotropin dose increment timing |
| Late dose increment | Active comparator | Patients who have received 25 IU gonadotropin dose increment on 14th day of ovulation induction Receives: Drug: Gonadotropin dose increment timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of preovulatory follicles
Number of >14 mm sized follicles at the end of the ovulation induction treatment
Measured: 35 days
Secondary outcomes (5)
Biochemical pregnancy rate
Serum pregnancy test will be performed 2 weeks after ovulation triggering
Measured: 2 weeks after ovulation triggering
Clinical pregnancy rate
Clinical pregnancy rate which will be evaluated 3 weeks after ovulation triggering
Measured: 3 weeks after ovulation triggering
Cycle length in days
Total number of ovulation induction days until ovulation triggering
Measured: 7-35 days
Cycle cancellation
Cycle cancellation due to >=3 preovulatory follicles (>14 mm in size) at the end of the ovulation induction treatment
Measured: 35 days
Multiple pregnancy rate
Multiple pregnancy rate which will be evaluated 3 weeks after ovulation triggering
Measured: 3 weeks after ovulation triggering
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start20 Aug 2020
- Primary completion20 Aug 2020
- Study completion20 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Kahyaoglu, Saglik Bilimleri Universitesi
- Investigators
- Serkan Kahyaoglu, M.D, Principal investigator, Ankara City Hospital, Department of Reproductive Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528849
- Sponsor's protocol ID
- E1-20-377
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ovulation Induction Cycle Outcomes Between Early and Late Dose Increments for Low Dose Gonadotropin Step-up Protocol Among Infertile Women Diagnosed With Polycystic Ovary Syndrome: Prospective Randomised Trial
- ClinicalTrials.gov ID
- NCT04528849
- Acronym / sponsor ID
- E1-20-377
- Conditions
- Polycystic Ovary Syndrome, Infertility, Female
- Keywords
- Polycystic ovary syndrome, Infertility, Low dose step-up, Gonadotropin, Ovulation induction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2022 (estimated)
- First posted
- 27 Aug 2020 (actual)
- 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.
Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome (PCOS). First dose increment is advised on 14th day of ovarian stimulation with gonadotropins to decrease multiple follicle generation and cycle cancellation rates. However, clinicians impatiently increase gonadotropin dose on 7th day of stimulation without strong scientific evidence. This randomised controlled study will be the first study which will compare safety and ovulation induction cyle outcomes of early and late dose increments among infertile women diagnosed with PCOS.
Detailed description
Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome. First dose increment is advised on 14th day of ovarian stimulation with gonadotropins to decrease multiple follicle generation and cycle cancellation rates. However, clinicians impatiently increase gonadotropin dose on 7th day of stimulation without strong scientific evidence. This randomised controlled study will be the first study which will compare safety and ovulation induction cyle outcomes of early and late dose increments among infertile women diagnosed with polycystic ovary syndrome.
We will start low dose step-up ovulation induction treatment by using 50 IU recombinant FSH for 21-39 years old non- obese patients (BMI <30 kg/m2) diagnosed with PCOS and . We will perform folliculometry on 7th day of ovulation induction. In case of absence for at least one >10 mm dominant follicle, we will randomise these women by using blind envelope selection method for assignment of early or late dose incerement groups. Half of the patients will receive 25 IU dose increment on 7th day of ovulation induction, remaining half will receive dose increment on 14th day of ovulation induction. We will continue ovarian stimulation without any other dose increment until 35th day of stimulation as deadline time restriction. We will perform folliculometry and serum estradiol measurement intermittently during ovulation induction. We will record ovulation induction cycle outcomes and clinical pregnancy results of the study group following finalization for treatment cyle of each patient. We will compare ovulation induction cycle outcomes of these two dose increment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early dose increment | Active comparator | Drug: Gonadotropin dose increment timingPatients who have received 25 IU gonadotropin dose increment on 7th day of ovulation induction |
| Late dose increment | Active comparator | Drug: Gonadotropin dose increment timingPatients who have received 25 IU gonadotropin dose increment on 14th day of ovulation induction |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gonadotropin dose increment timingGonadotropin dose increments of 25 IU will be utilized on 7th and 14th day of ovulation induction for each study group. | Drug | Early dose increment, Late dose increment |
Primary outcome
Number of preovulatory follicles
Time frame: 35 days
Number of >14 mm sized follicles at the end of the ovulation induction treatment
5 secondary outcomes
Biochemical pregnancy rate
Time frame: 2 weeks after ovulation triggering
Clinical pregnancy rate
Time frame: 3 weeks after ovulation triggering
Cycle length in days
Time frame: 7-35 days
Cycle cancellation
Time frame: 35 days
Multiple pregnancy rate
Time frame: 3 weeks after ovulation triggering
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Improved monofollicular ovulation in anovulatory or oligo-ovulatory women after a low-dose step-up protocol with weekly increments of 25 international units of follicle-stimulating hormoneLink provided by the sponsor.
- Pilot study of the optimal protocol of low dose step-up follicle stimulating hormone therapy for infertile womenLink provided by the sponsor.
- Ovulation induction with a starting dose of 50 IU of recombinant follicle stimulating hormone in WHO group II anovulatory women: the IO-50 study, a prospective, observational, multicentre, open trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Serkan Kahyaoglu, M.D principal investigator
Ankara City Hospital, Department of Reproductive Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gonadotropin dose increment timing in people with Polycystic Ovary Syndrome and Infertility, Female, run by Saglik Bilimleri Universitesi 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?
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 27 Aug 2020. 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 Serkan Kahyaoglu, M.D (+905058868040, serkan.kahyaoglu@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of preovulatory follicles (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2020.