InfertilityPhase 3NCT01006954
Outcome of Two Protocols in Poor Responders in Assisted Reproductive Technology (ART) Cycle
A Phase 3 study testing Microdose GnRh and Flare up in people with Infertility, run by Royan Institute at 1 site in Iran.
Trial summary
About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments have been suggested for increasing pregnancy rate. Read more about this study
- Who is it for?
- Ages 30 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Microdose GnRh and Flare up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIran
- Study dates
- Sep 2008to Feb 2010
- Phase
- Phase 3
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Poor responders (Presence of at least two of following items is necessary for inclusion to the study)
- History of Cycle Cancellation
- History of oocyte number 3 (in previous cycle)
- History of Number of antral follicle < 5 in previous cycle
- Age≥38
- FSH>12 on day 2 or 3
- Ovarian Volume 3 cm3
Who cannot join
- Male factor (azospermi)
- Myoma ≥6cm
- One way ovary
- Tumor or cyst >13mm
- Age >42
Trial locations and contacts
1 site in 1 country.
Iran1 site
1- Endocrinology and Female Infertility Department, Reproductive Medicine Research Centre, Royan Institute, ACECR
Tehran, 14114
About this study
Official title: Comparison of Micro Dose Gonadotropin-Releasing Hormone (GnRH) Agonist Flare up & Flare Protocol in Poor Responders in Assisted Reproductive Technology (ART) Cycle
About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments have been suggested for increasing pregnancy rate. In this study, the investigators will compare the outcome of Microflare protocol and Flare up regimen in poor responders.
Read the detailed description
In this randomized clinical trial study, a total of 200 infertile women with poor ovarian response who undergo IVF / ICSI treatment cycle at Royan Institute will enroll in this study and will randomly be divided into two groups of 100 patients. This study has been approved by Royan ethics committee and written consent will be obtained from each patient.
The patients will be randomized to one of two groups of Flare Up or Microdose GnRh agonist flare up.
Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), Estradiol, will be evaluated on day 2 or 3 and when follicle size become >14.
2 weeks after embryo transfer, the patients will be tested for serum β-hCG for assessing the pregnancy. The clinical pregnancy will be clarified by the number of women with gestational sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the number of gestational sacs will be considered.
- Conditions
- Infertility
- Being tested
- Microdose GnRh, Flare up
- Keywords
- Poor responder, Flare up, Micro dose GnRH agonist flare up, IVF/ICSI
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdose GnRhDrug
Also called Case
Microflare protocol in poor responders for IVF/ICSI
Flare upDrug
Also called Standard treatment
Flare up protocol in poor responders for IVF/ICSI
| Study group | Role | What they receive |
|---|---|---|
| Flare Up | Active comparator | Flare up protocol in poor responders for IVF/ICSI Receives: Drug: Flare up |
| Microdose GnRh | Experimental | Microflare protocol in poor responders for IVF/ICSI Receives: Drug: Microdose GnRh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Measured: 12 months
Secondary outcomes (5)
Cycle cancellation rates
Measured: 12 Months
Number of oocytes generated
Measured: 12 Months
Number of embryos generated
Measured: 12 Months
Implantation rate
Measured: 12 Months
Pregnancy rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionFeb 2010
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tahereh Madani, MD, Study chair, Royan InstituteFiroozeh Ghaffari, MD, Study director, Royan InstituteTahereh Madani, MD, Principal investigator, Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006954
- Sponsor's protocol ID
- Royan-Emb-003
- Status last verified
- Nov 2009
- First submitted
- 2 Nov 2009
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ghaffari F, Jahangiri N, Madani T, Khodabakhshi S, Chehrazi M. Randomized controlled trial of gonadotropin-releasing hormone agonist microdose flare-up versus flare-up among poor responders undergoing intracytoplasmic sperm injection. Int J Gynaecol Obstet. 2020 Jan;148(1):59-64. doi: 10.1002/ijgo.12988. Epub 2019 Oct 18.
PubMed 31569274
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Micro Dose Gonadotropin-Releasing Hormone (GnRH) Agonist Flare up & Flare Protocol in Poor Responders in Assisted Reproductive Technology (ART) Cycle
- ClinicalTrials.gov ID
- NCT01006954
- Acronym / sponsor ID
- Royan-Emb-003
- Conditions
- Infertility
- Keywords
- Poor responder, Flare up, Micro dose GnRH agonist flare up, IVF/ICSI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 3 Nov 2009 (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.
About 9 to 24 % of women undergoing in vitro fertilization (IVF) treatment respond poorly to the usual gonadotrophin stimulation protocol applied. Several induction ovulation treatments have been suggested for increasing pregnancy rate. In this study, the investigators will compare the outcome of Microflare protocol and Flare up regimen in poor responders.
Detailed description
In this randomized clinical trial study, a total of 200 infertile women with poor ovarian response who undergo IVF / ICSI treatment cycle at Royan Institute will enroll in this study and will randomly be divided into two groups of 100 patients. This study has been approved by Royan ethics committee and written consent will be obtained from each patient.
The patients will be randomized to one of two groups of Flare Up or Microdose GnRh agonist flare up.
Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), Estradiol, will be evaluated on day 2 or 3 and when follicle size become >14.
2 weeks after embryo transfer, the patients will be tested for serum β-hCG for assessing the pregnancy. The clinical pregnancy will be clarified by the number of women with gestational sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the number of gestational sacs will be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flare Up | Active comparator | Drug: Flare upFlare up protocol in poor responders for IVF/ICSI |
| Microdose GnRh | Experimental | Drug: Microdose GnRhMicroflare protocol in poor responders for IVF/ICSI |
Who may qualify
- Ages
- 30 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Poor responders (Presence of at least two of following items is necessary for inclusion to the study)
- History of Cycle Cancellation
- History of oocyte number 3 (in previous cycle)
- History of Number of antral follicle < 5 in previous cycle
- Age≥38
Key exclusion criteria (5 listed)
- Male factor (azospermi)
- Myoma ≥6cm
- One way ovary
- Tumor or cyst >13mm
- Age >42
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 |
|---|---|---|
| Microdose GnRhAlso: CaseMicroflare protocol in poor responders for IVF/ICSI | Drug | Microdose GnRh |
| Flare upAlso: Standard treatmentFlare up protocol in poor responders for IVF/ICSI | Drug | Flare Up |
Primary outcome
Live birth rate
Time frame: 12 months
5 secondary outcomes
Cycle cancellation rates
Time frame: 12 Months
Number of oocytes generated
Time frame: 12 Months
Number of embryos generated
Time frame: 12 Months
Implantation rate
Time frame: 12 Months
Pregnancy rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Derived from this study: PubMed 31569274Ghaffari F, Jahangiri N, Madani T, Khodabakhshi S, Chehrazi M. Randomized controlled trial of gonadotropin-releasing hormone agonist microdose flare-up versus flare-up among poor responders undergoing intracytoplasmic sperm injection. Int J Gynaecol Obstet. 2020 Jan;148(1):59-64. doi: 10.1002/ijgo.12988. Epub 2019 Oct 18.
- Related InfoLink 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.
Tahereh Madani, MD study chair
Royan Institute
Firoozeh Ghaffari, MD study director
Royan Institute
Tahereh Madani, MD principal investigator
Royan Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Microdose GnRh and Flare up in people with Infertility, run by Royan Institute at 1 site in Iran.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 19 Dec 2018. 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 Iran. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Live birth rate (time frame: 12 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 NCT01006954, 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 19 Dec 2018.