PCOSNCT01112111
A Novel Stimulation Protocol and the Conventional Low Dose Step-up and Step Down Regimens
An observational study of PCOS, run by Genesis Center for Fertility & Human Pre-Implantation Genetics at 1 site in Cyprus.
Trial summary
This study is designed to compare the efficacy of a novel stimulation protocol with the conventional low dose step-up and step down regimens in older than 30 years PCOS patients undergoing in vitro fertilisation. Read more about this study
- Who is it for?
- Ages 30 to 36 years
- Conditions the study is for
- PCOS
- What is being tested?
- mode of gonadotropin administration
- How many people
- 225 participants
- Where
- 1 siteCyprus
- Study dates
- May 2010to Sep 2010
- 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 30 to 36 years
- All sexes
- No healthy volunteers
- Adult
Study population: PCOS is defined as the presence of polycystic ovaries, described as enlarged under US with more than 10 cysts (2 and 8 mm) in mean diameter and symptoms of oligomenorhrea/ amenorhea, high LH/FSH ratio, obesity, hyperandrogenism hirsuitism and acnes), and withdrawal bleeding after administration of progesterone. All women had either failed to ovulate after receiving a maximum daily dosage of 100-150 mg of clomiphene citrate for 5 days or failed to conceive after at least three ovulatory cycles using CC or gonadotropin treatment. Other inclusion criteria included: patients between 30 and 36 years old with patent fallopian tubes, no previous IVF attempts, and nortmo-spermic partners.
Who may be able to join
- Failure to ovulate after CC treatment
- Over than 30 years of age No Previous IVF attempts
- Patent Fallopian Tubes
- Normo-spermic partners
Who cannot join
- Secondary Infertility
- Younger than 30 years
- Older than 36 years
- Other infertility cause
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
Genesis Centre for Fertility and Human Pre-implantation Genetics
Limassol, Limassol District, 3025
About this study
Official title: Conventional Step-up, Step Down and a Novel Stimulation Regime in Controlled Ovarian Stimulation of Older Than 30 Years PCOS Patients Undergoing IVF- A Prospective Randomized Study.
This study is designed to compare the efficacy of a novel stimulation protocol with the conventional low dose step-up and step down regimens in older than 30 years PCOS patients undergoing in vitro fertilisation. The novel regime was proposed under the basis of the combined effectiveness of the two standard protocols to induce a uniform follicular growth and forms a continuation to the author's previously published results examining a similar approach in younger PCOS candidates. In total 225 patients have been recruited for this study. The stimulation protocol will be assigned under the basis of prospective randomization using sealed and numbered envelopes. All patients will be down regulated using a desensitisation agent administered on day 2 of spontaneous or induced withdrawal bleeding. The initial dosage in the low dose step-up regimen (group A) will be 150 IU/d of FSH for the first 6 days followed by an increase of 75 IU thereafter. In the step-down regimen (group B) patients will administer a starting dose of 300 IU/d of FSH for the first 3 days followed by a decrease to 225 IU/d for the next 3 days. This dosage will be further decreased to 150 IU/d or sustained at 225 IU (according to the initial response) until the day of the hCG injection. Group C, patients received 225 IU on day 1 followed by a decrease to 150 IU on day 2. On day 3 the dosage will be increased back to 225 IU. This alternation of injection dosage will be followed until day 6. According to the initial ovarian response the dosage will be sustained at 225 IU/d or 150 IU/d until the day of the hCG injection. The 10,000 IU hCG will be administered when at least two follicles had reached a mean diameter of 18 mm and the serum E2 levels were consistent with the ultrasound findings. Egg retrieval will be undertaken at 35 hours after the administration of the hCG injection. Oocytes recovered will be inseminated 4 hours post egg collection. Patients will receive 3 embryos on the third day of development. The luteal phase will be supported by progesterone suppositories starting on the day of the egg collection. A positive outcome will be detected by a serum β-hCG analysis 13 days after embryo replacement. The presence of a fetal heart pulse on ultrasound 3 weeks later confirmed a clinical pregnancy.
- Conditions
- PCOS
- Being tested
- mode of gonadotropin administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mode of gonadotropin administrationDrug
Low dose step-up administration Step down administration sequential administration
| Study group | Role | What they receive |
|---|---|---|
| 75 PCOS Patients - step up regime | Group A will be comprised of 75 patients and these will receive a low dose step stimulation regime Receives: Drug: mode of gonadotropin administration | |
| 75 PCOS patients -step down regime | Group B will be comprised of 75 patients who will receive a step down regime of stimulation Receives: Drug: mode of gonadotropin administration | |
| 75 PCOS patients - sequential regime | Group C will be comprised of 75 patients who will be treated using a sequential stimulation regime Receives: Drug: mode of gonadotropin administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
Measured: The primary outcome measure will be assessed upon completion of the study estimated to September 2010
Secondary outcomes (1)
Ovarian Response
Measured: The secondary outcome measure will be assessed upon completion of the controlled ovarian stimulation and the egg collection procedures. This parameter will be made known at least 5 weeks prior to the primary outcome mesure being availablle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genesis Center for Fertility & Human Pre-Implantation Genetics
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112111
- Sponsor's protocol ID
- PCOS
- Other IDs
- PCOS2, livfe67
- Status last verified
- Apr 2010
- First submitted
- 26 Apr 2010
- Last updated
- 28 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Step-up, Step Down and a Novel Stimulation Regime in Controlled Ovarian Stimulation of Older Than 30 Years PCOS Patients Undergoing IVF- A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT01112111
- Acronym / sponsor ID
- PCOS
- Conditions
- PCOS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Genesis Center for Fertility & Human Pre-Implantation GeneticsUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2010 (estimated)
- First posted
- 28 Apr 2010 (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.
This study is designed to compare the efficacy of a novel stimulation protocol with the conventional low dose step-up and step down regimens in older than 30 years PCOS patients undergoing in vitro fertilisation. The novel regime was proposed under the basis of the combined effectiveness of the two standard protocols to induce a uniform follicular growth and forms a continuation to the author's previously published results examining a similar approach in younger PCOS candidates. In total 225 patients have been recruited for this study. The stimulation protocol will be assigned under the basis of prospective randomization using sealed and numbered envelopes. All patients will be down regulated using a desensitisation agent administered on day 2 of spontaneous or induced withdrawal bleeding. The initial dosage in the low dose step-up regimen (group A) will be 150 IU/d of FSH for the first 6 days followed by an increase of 75 IU thereafter. In the step-down regimen (group B) patients will administer a starting dose of 300 IU/d of FSH for the first 3 days followed by a decrease to 225 IU/d for the next 3 days. This dosage will be further decreased to 150 IU/d or sustained at 225 IU (according to the initial response) until the day of the hCG injection. Group C, patients received 225 IU on day 1 followed by a decrease to 150 IU on day 2. On day 3 the dosage will be increased back to 225 IU. This alternation of injection dosage will be followed until day 6. According to the initial ovarian response the dosage will be sustained at 225 IU/d or 150 IU/d until the day of the hCG injection. The 10,000 IU hCG will be administered when at least two follicles had reached a mean diameter of 18 mm and the serum E2 levels were consistent with the ultrasound findings. Egg retrieval will be undertaken at 35 hours after the administration of the hCG injection. Oocytes recovered will be inseminated 4 hours post egg collection. Patients will receive 3 embryos on the third day of development. The luteal phase will be supported by progesterone suppositories starting on the day of the egg collection. A positive outcome will be detected by a serum β-hCG analysis 13 days after embryo replacement. The presence of a fetal heart pulse on ultrasound 3 weeks later confirmed a clinical pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 75 PCOS Patients - step up regime | – | Drug: mode of gonadotropin administrationGroup A will be comprised of 75 patients and these will receive a low dose step stimulation regime |
| 75 PCOS patients -step down regime | – | Drug: mode of gonadotropin administrationGroup B will be comprised of 75 patients who will receive a step down regime of stimulation |
| 75 PCOS patients - sequential regime | – | Drug: mode of gonadotropin administrationGroup C will be comprised of 75 patients who will be treated using a sequential stimulation regime |
Who may qualify
- Ages
- 30 to 36 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- PCOS is defined as the presence of polycystic ovaries, described as enlarged under US with more than 10 cysts (2 and 8 mm) in mean diameter and symptoms of oligomenorhrea/ amenorhea, high LH/FSH ratio, obesity, hyperandrogenism hirsuitism and acnes), and withdrawal bleeding after administration of progesterone. All women had either failed to ovulate after receiving a maximum daily dosage of 100-150 mg of clomiphene citrate for 5 days or failed to conceive after at least three ovulatory cycles using CC or gonadotropin treatment. Other inclusion criteria included: patients between 30 and 36 years old with patent fallopian tubes, no previous IVF attempts, and nortmo-spermic partners.
Key inclusion criteria (4 listed)
- Failure to ovulate after CC treatment
- Patent Fallopian Tubes
- Normo-spermic partners
Key exclusion criteria (4 listed)
- Secondary Infertility
- Younger than 30 years
- Older than 36 years
- Other infertility cause
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 |
|---|---|---|
| mode of gonadotropin administrationLow dose step-up administration Step down administration sequential administration | Drug | 75 PCOS Patients - step up regime, 75 PCOS patients - sequential regime, 75 PCOS patients -step down regime |
Primary outcome
Pregnancy Rate
Time frame: The primary outcome measure will be assessed upon completion of the study estimated to September 2010
1 secondary outcome
Ovarian Response
Time frame: The secondary outcome measure will be assessed upon completion of the controlled ovarian stimulation and the egg collection procedures. This parameter will be made known at least 5 weeks prior to the primary outcome mesure being availablle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 PCOS, run by Genesis Center for Fertility & Human Pre-Implantation Genetics at 1 site in Cyprus.
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 4 inclusion and 4 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 28 Apr 2010. 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 Cyprus. 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?
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?
Pregnancy Rate (time frame: The primary outcome measure will be assessed upon completion of the study estimated to September 2010). 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 28 Apr 2010.