InfertilityNCT02114645
The Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes
A study testing Leuprolide acetate, vaginal progesterone and 4 mg oral estradiol valerate in people with Infertility, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Leuprolide acetate, vaginal progesterone and 4 mg oral estradiol valerate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2014to Apr 2015
- 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 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Couples undergoing ART with their own gametes.
- Couples having at least one good embryo available for transfer.
- Normoresponder
- Infertility etiology is unexplained
- ovulation triggered by intramuscular injection of 10000 IU of HCG
Who cannot join
- Patients older than 38 years old
- High and poor responder patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Hospital
Ankara, Cankaya, 06500
About this study
Official title: To Evaluate the Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes in Both GnRH Agonist and GnRH Antagonist Treated Ovarian Stimulation Protocols
This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol.
Read the detailed description
This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol. Decision between each of these two protocols was subjective and depended on the clinical context.In addition to routine luteal phase support with progesterone and estradiol valerate,women received two dose of GnRH agonist on the fifth and tenth day after ET.Live birth rate was the primary outcome measure.
- Conditions
- Infertility
- Being tested
- Leuprolide acetate, vaginal progesterone, 4 mg oral estradiol valerate
- Keywords
- Luteal phase support,GnRH agonist,ART cycles
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide acetateDrug
Also called lucrin
in experimentals groups,on fifth and tenth day after embryo transfer 0,5mg leuprolide acetate is given subcutaneously as luteal phase support
vaginal progesteroneDrug
Also called crinone gel
crinone gel is applied till fetal heart beat is detected
4 mg oral estradiol valerateDrug
Also called estrofem 2mg tablet
estrofem is given twice a day
| Study group | Role | What they receive |
|---|---|---|
| LongGnRH agonist protocol(controlgroup) | Active comparator | Long GnRH agonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate Receives: Drug: vaginal progesterone; Drug: 4 mg oral estradiol valerate |
| Long protocol-leuprolide acetate | Experimental | Long GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer Receives: Drug: Leuprolide acetate; Drug: vaginal progesterone; Drug: 4 mg oral estradiol valerate |
| GnRHantagonist protocol(control group) | Active comparator | GnRH antagonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate Receives: Drug: vaginal progesterone; Drug: 4 mg oral estradiol valerate |
| antagonist protocol-leuprolide acetate | Experimental | GnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer Receives: Drug: Leuprolide acetate; Drug: vaginal progesterone; Drug: 4 mg oral estradiol valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate
Measured: 42 weeks
Secondary outcomes (3)
Ongoing pregnancy
Measured: more than 20 weeks
miscarriage
Measured: up to 20 weeks
OHSS
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagihan CENGAVER, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Nagihan Cengaver, Resident, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114645
- Sponsor's protocol ID
- ZTB-5030
- Other IDs
- ZTB5030
- Status last verified
- Apr 2014
- First submitted
- 8 Apr 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes in Both GnRH Agonist and GnRH Antagonist Treated Ovarian Stimulation Protocols
- ClinicalTrials.gov ID
- NCT02114645
- Acronym / sponsor ID
- ZTB-5030
- Conditions
- Infertility
- Keywords
- Luteal phase support,GnRH agonist,ART cycles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 15 Apr 2014 (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 prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol.
Detailed description
This prospective clinical trial evaluates the effect of a two dose GnRH agonist administered in the luteal phase on the outcome of ART cycles stimulated with the long GnRH agonist and GnRH antagonist protocol. Decision between each of these two protocols was subjective and depended on the clinical context.In addition to routine luteal phase support with progesterone and estradiol valerate,women received two dose of GnRH agonist on the fifth and tenth day after ET.Live birth rate was the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LongGnRH agonist protocol(controlgroup) | Active comparator | Drug: vaginal progesterone, Drug: 4 mg oral estradiol valerateLong GnRH agonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate |
| Long protocol-leuprolide acetate | Experimental | Drug: Leuprolide acetate, Drug: vaginal progesterone, Drug: 4 mg oral estradiol valerateLong GnRH agonist protocol Luteal Phase Support: Vaginal progesterone+oral estradiol valerate subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer |
| GnRHantagonist protocol(control group) | Active comparator | Drug: vaginal progesterone, Drug: 4 mg oral estradiol valerateGnRH antagonist protocol ( control group) Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate |
| antagonist protocol-leuprolide acetate | Experimental | Drug: Leuprolide acetate, Drug: vaginal progesterone, Drug: 4 mg oral estradiol valerateGnRH antagonist protocol Luteal Phase Support: Vaginal progesterone + 4mg oral estradiol valerate + subcutaneous 0.5mg leuprolide acetate fifth and tenth day after embryo transfer |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Couples undergoing ART with their own gametes.
- Couples having at least one good embryo available for transfer.
- Normoresponder
- Infertility etiology is unexplained
- ovulation triggered by intramuscular injection of 10000 IU of HCG
Key exclusion criteria (2 listed)
- Patients older than 38 years old
- High and poor responder patients
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 |
|---|---|---|
| Leuprolide acetateAlso: lucrinin experimentals groups,on fifth and tenth day after embryo transfer 0,5mg leuprolide acetate is given subcutaneously as luteal phase support | Drug | Long protocol-leuprolide acetate, antagonist protocol-leuprolide acetate |
| vaginal progesteroneAlso: crinone gelcrinone gel is applied till fetal heart beat is detected | Drug | GnRHantagonist protocol(control group), Long protocol-leuprolide acetate, LongGnRH agonist protocol(controlgroup), antagonist protocol-leuprolide acetate |
| 4 mg oral estradiol valerateAlso: estrofem 2mg tabletestrofem is given twice a day | Drug | GnRHantagonist protocol(control group), Long protocol-leuprolide acetate, LongGnRH agonist protocol(controlgroup), antagonist protocol-leuprolide acetate |
Primary outcome
Live Birth Rate
Time frame: 42 weeks
3 secondary outcomes
Ongoing pregnancy
Time frame: more than 20 weeks
miscarriage
Time frame: up to 20 weeks
OHSS
Time frame: up to 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles.Link provided by the sponsor.
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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.
Nagihan Cengaver, Resident principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leuprolide acetate, vaginal progesterone and 4 mg oral estradiol valerate in people with Infertility, run by Zekai Tahir Burak Women's Health Research and Education 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 5 inclusion and 2 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 15 Apr 2014. 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 Nagihan Cengaver, MD (+905556309298, nagihancengaver@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth Rate (time frame: 42 weeks). 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 15 Apr 2014.