PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI CyclesPCOS and ivfNCT01354275
In Vitro Fertilization Outcomes of Two Treatment Protocols in Women With Polycystic Ovary Syndrome
A study testing To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle and GnRH Antagonist in people with PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles, run by Bulent Haydardedeoglu at 1 site in Turkey (Türkiye).
Trial summary
Outcomes of IVF/ICSI cycles of women with PCOS undergoing Gonadotropin Releasing Hormone (GnRH) agonist and GnRH Antagonist fixed protocol. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles
- What is being tested?
- To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle and GnRH Antagonist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2009to Jun 2011
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PCOS women undergoing ICSI cycles
- All women will be administered 150 IU rec FSH
Who cannot join
- Women having other endocrinopathies
- women older than 35
- third IVF/ICSI cycles
- previous and current use of metformin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IVF/ICSI Outcomes of OCP Plus GnRH Agonist Protocol Versus OCP Plus GnRH Antagonist Fixed Protocol in Women With PCOS
Outcomes of IVF/ICSI cycles of women with PCOS undergoing Gonadotropin Releasing Hormone (GnRH) agonist and GnRH Antagonist fixed protocol.
Read the detailed description
Women with PCOS undergoing IVF/ICSI cycles will be evaluated by two different protocols. One arm of the study includes oral contraceptive plus GnRH agonist protocol with 150 IU FSH (standard dose) and second arm includes oral contraceptive plus GnRH Antagonist with 150 IU FSH dose and fixed 6th day starting of GnRH Antagonist.
- Being tested
- To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle, GnRH Antagonist
- Keywords
- PCOS, IVF/ICSI, Clinical Pregnancy rates, GnRH Antagonist, GnRH Agonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycleOther
150 IU FSH dose and OCP plus GnRH Agonist (long luteal) IVF/ICSI cycle and 150 IU FSH dose and OCP plus GnRH Antagonist (Fixed protocol) IVF/ICSI Cycle
GnRH AntagonistOther
GnRH Antagonist cycle; 150 IU FSH and sixth day Antagonist will be administered
| Study group | Role | What they receive |
|---|---|---|
| GnRH Agonist | Active comparator | oral contraceptive pill and GnRH Agonist IVF/ICSI cycle Receives: Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle |
| GnRH Agonist Arm | Active comparator | Oral contraceptive pill and day 21 GnRH agonist began, Day 3 of menstruation 150 IU FSH will be started. If 3 or more follicle reach >17 mm hCG will be administered. Receives: Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle; Other: GnRH Antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rates
Ongoing pregnancy rates measured in OCP plus GnRH Agonist and OCP plus GnRH Antagonist cycles in women with PCOS
Measured: March 2009 to June 2011
clinical pregnancy rate
To evaluate the clinical pregnancy rates of both study arms
Measured: from march 2009 to july 2011
Total gonadotropin use
Total gonadotropin use of both study arms
Measured: From march 2009 to June 2011
Secondary outcomes (2)
OHSS rates
OHSS rates in both study groups
Measured: from march 2009 to july 2011
Total ongoing pregnancy rate
Total ongoing pregnacy rates of per protocol group including freezing-thawing embryo transfer cycles.
Measured: from march 2009 to june 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startMar 2009
- Primary completionMar 2011
- Study completionJun 2011
Why it stopped: . The trial would be continued if there was a difference of ≥3 % between trial arms. However, the difference between ongoing pregnancy rates was \<1 %
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI CyclesStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Haydardedeoglu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bulent Haydardedeoglu, Baskent University
- Investigators
- Bulent Haydardedeoglu, M.D., Study chair, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354275
- Sponsor's protocol ID
- BH532008
- Other IDs
- KA04/104
- Acronym
- PCOS and ivf
- Status last verified
- Feb 2012
- First submitted
- 12 May 2011
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVF/ICSI Outcomes of OCP Plus GnRH Agonist Protocol Versus OCP Plus GnRH Antagonist Fixed Protocol in Women With PCOS
- ClinicalTrials.gov ID
- NCT01354275
- Acronym / sponsor ID
- PCOS and ivf / BH532008
- Keywords
- PCOS, IVF/ICSI, Clinical Pregnancy rates, GnRH Antagonist, GnRH Agonist
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: . The trial would be continued if there was a difference of ≥3 % between trial arms. However, the difference between ongoing pregnancy rates was \<1 %
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Bulent HaydardedeogluUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 May 2011 (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.
Outcomes of IVF/ICSI cycles of women with PCOS undergoing Gonadotropin Releasing Hormone (GnRH) agonist and GnRH Antagonist fixed protocol.
Detailed description
Women with PCOS undergoing IVF/ICSI cycles will be evaluated by two different protocols. One arm of the study includes oral contraceptive plus GnRH agonist protocol with 150 IU FSH (standard dose) and second arm includes oral contraceptive plus GnRH Antagonist with 150 IU FSH dose and fixed 6th day starting of GnRH Antagonist.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH Agonist | Active comparator | Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycleoral contraceptive pill and GnRH Agonist IVF/ICSI cycle |
| GnRH Agonist Arm | Active comparator | Other: To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle, Other: GnRH AntagonistOral contraceptive pill and day 21 GnRH agonist began, Day 3 of menstruation 150 IU FSH will be started. If 3 or more follicle reach >17 mm hCG will be administered. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- PCOS women undergoing ICSI cycles
- All women will be administered 150 IU rec FSH
Key exclusion criteria (4 listed)
- Women having other endocrinopathies
- women older than 35
- third IVF/ICSI cycles
- previous and current use of metformin
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 |
|---|---|---|
| To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle150 IU FSH dose and OCP plus GnRH Agonist (long luteal) IVF/ICSI cycle and 150 IU FSH dose and OCP plus GnRH Antagonist (Fixed protocol) IVF/ICSI Cycle | Other | GnRH Agonist, GnRH Agonist Arm |
| GnRH AntagonistGnRH Antagonist cycle; 150 IU FSH and sixth day Antagonist will be administered | Other | GnRH Agonist Arm |
Primary outcome
Ongoing pregnancy rates
Time frame: March 2009 to June 2011
Ongoing pregnancy rates measured in OCP plus GnRH Agonist and OCP plus GnRH Antagonist cycles in women with PCOS
clinical pregnancy rate
Time frame: from march 2009 to july 2011
To evaluate the clinical pregnancy rates of both study arms
Total gonadotropin use
Time frame: From march 2009 to June 2011
Total gonadotropin use of both study arms
2 secondary outcomes
OHSS rates
Time frame: from march 2009 to july 2011
Total ongoing pregnancy rate
Time frame: from march 2009 to june 2011
Results and safety
The study was stopped early (reason given: . The trial would be continued if there was a difference of ≥3 % between trial arms. However, the difference between ongoing pregnancy rates was \<1 %). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
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.
Bulent Haydardedeoglu, M.D. study chair
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle and GnRH Antagonist in people with PCOS GnRH Antagonist and GnRH Agonist IVF/ICSI Cycles, run by Bulent Haydardedeoglu 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 2 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: stopped early, as of the sponsor's last update on 3 Feb 2012. 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?
The study was stopped early (reason given: . The trial would be continued if there was a difference of ≥3 % between trial arms. However, the difference between ongoing pregnancy rates was \<1 %). 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?
Ongoing pregnancy rates (time frame: March 2009 to June 2011). The study lists 3 primary outcomes in all. 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 3 Feb 2012.